EMA Write PMS API Implementation Guide - Enrichments
1.2.0 - ci-build

EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: EmaWriteApiMedicinalProductDefinition - Detailed Descriptions

Draft as of 2025-08-08

Definitions for the emaWriteApiMedicinalProductDefinition resource profile.

Guidance on how to interpret the contents of this table can be found here

0. MedicinalProductDefinition
Definition

A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).

ShortDetailed definition of a medicinal product
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
2. MedicinalProductDefinition.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

ShortA set of rules under which this content was created
Comments

Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

Control0..01
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. MedicinalProductDefinition.language
Definition

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

Control0..01
BindingThe codes SHALL be taken from AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0
(required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

IETF language tag for a human language

Typecode
Is Modifierfalse
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summaryfalse
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
6. MedicinalProductDefinition.text
Definition

A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

ShortText summary of the resource, for human interpretation
Comments

Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

Control0..01
This element is affected by the following invariants: dom-6
TypeNarrative
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesnarrative, html, xhtml, display
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
8. MedicinalProductDefinition.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

ShortContained, inline Resources
Comments

This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

Control0..0*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
10. MedicinalProductDefinition.extension
Definition

Authorised Dose Form


May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

ShortAuthorised Dose Form
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control1..*
TypeExtension(Authorised Dose Form) (Extension Type: Coding(EMA Coding))
Is Modifierfalse
Must Supportfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
12. MedicinalProductDefinition.modifierExtension
Definition

An Extension


May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

ShortExtensionExtensions that cannot be ignored
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..0*
TypeExtension
Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Supportfalse
Summarytrue
Requirements

Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
14. MedicinalProductDefinition.identifier
Definition

Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.

ShortBusiness identifier for this product. Could be an MPID
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..3*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
Summarytrue
Alternate NamesMPID
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on MedicinalProductDefinition.identifier. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
  • value @ system
  • 16. MedicinalProductDefinition.identifier.extension
    Definition

    An Extension


    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

    ShortExtensionAdditional content defined by implementations
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..0*
    TypeExtension
    Is Modifierfalse
    Summaryfalse
    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    SlicingThis element introduces a set of slices on MedicinalProductDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 18. MedicinalProductDefinition.identifier.use
      Definition

      The purpose of this identifier.

      Shortusual | official | temp | secondary | old (If known)
      Comments

      Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

      Control0..01
      BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
      (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

      Identifies the purpose for this identifier, if known .

      Typecode
      Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Summarytrue
      Requirements

      Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      20. MedicinalProductDefinition.identifier.type
      Definition

      A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

      ShortDescription of identifier
      Comments

      This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

      Control0..01
      BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type
      (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

      A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

      TypeCodeableConcept
      Is Modifierfalse
      Summarytrue
      Requirements

      Allows users to make use of identifiers when the identifier system is not known.

      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      22. MedicinalProductDefinition.identifier.period
      Definition

      Time period during which identifier is/was valid for use.

      ShortTime period when id is/was valid for use
      Control0..01
      TypePeriod
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      24. MedicinalProductDefinition.identifier.assigner
      Definition

      Organization that issued/manages the identifier.

      ShortOrganization that issued id (may be just text)
      Comments

      The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

      Control0..01
      TypeReference(Organization)
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      26. MedicinalProductDefinition.identifier:eurdId
      Slice NameeurdId
      Definition

      Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.

      ShortBusiness identifier for this product. Could be an MPID
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..1*
      TypeIdentifier(EMA EURD Identifier)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Alternate NamesMPID
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      28. MedicinalProductDefinition.identifier:eurdId.extension
      Definition

      An Extension


      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

      ShortExtensionAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..0*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on MedicinalProductDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 30. MedicinalProductDefinition.identifier:eurdId.use
        Definition

        The purpose of this identifier.

        Shortusual | official | temp | secondary | old (If known)
        Comments

        Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

        Control0..01
        BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
        (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

        Identifies the purpose for this identifier, if known .

        Typecode
        Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        32. MedicinalProductDefinition.identifier:eurdId.type
        Definition

        A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

        ShortDescription of identifier
        Comments

        This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

        Control0..01
        BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type
        (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

        A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

        TypeCodeableConcept
        Is Modifierfalse
        Summarytrue
        Requirements

        Allows users to make use of identifiers when the identifier system is not known.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        34. MedicinalProductDefinition.identifier:eurdId.system
        Definition

        Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

        ShortThe namespace for the identifier value
        Comments

        Identifier.system is always case sensitive.

        Control10..1
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

        Pattern Valuehttp://ema.europa.eu/fhir/eurdId
        Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        36. MedicinalProductDefinition.identifier:eurdId.value
        Definition

        The portion of the identifier typically relevant to the user and which is unique within the context of the system.

        ShortThe value that is unique
        Comments

        If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

        Control10..1
        This element is affected by the following invariants: ident-1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Example<br/><b>General</b>:123456
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        38. MedicinalProductDefinition.identifier:eurdId.period
        Definition

        Time period during which identifier is/was valid for use.

        ShortTime period when id is/was valid for use
        Control0..01
        TypePeriod
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        40. MedicinalProductDefinition.identifier:eurdId.assigner
        Definition

        Organization that issued/manages the identifier.

        ShortOrganization that issued id (may be just text)
        Comments

        The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

        Control0..01
        TypeReference(Organization)
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        42. MedicinalProductDefinition.identifier:mpId
        Slice NamempId
        Definition

        Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.

        ShortBusiness identifier for this product. Could be an MPID
        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..1*
        TypeIdentifier(EMA MP Identifier)
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Alternate NamesMPID
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        44. MedicinalProductDefinition.identifier:mpId.extension
        Definition

        An Extension


        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        ShortExtensionAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..0*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on MedicinalProductDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 46. MedicinalProductDefinition.identifier:mpId.use
          Definition

          The purpose of this identifier.

          Shortusual | official | temp | secondary | old (If known)
          Comments

          Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

          Control0..01
          BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
          (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

          Identifies the purpose for this identifier, if known .

          Typecode
          Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          48. MedicinalProductDefinition.identifier:mpId.type
          Definition

          A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

          ShortDescription of identifier
          Comments

          This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

          Control0..01
          BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type
          (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

          A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

          TypeCodeableConcept
          Is Modifierfalse
          Summarytrue
          Requirements

          Allows users to make use of identifiers when the identifier system is not known.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          50. MedicinalProductDefinition.identifier:mpId.system
          Definition

          Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

          ShortThe namespace for the identifier value
          Comments

          Identifier.system is always case sensitive.

          Control10..1
          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

          Pattern Valuehttp://ema.europa.eu/fhir/mpId
          Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          52. MedicinalProductDefinition.identifier:mpId.value
          Definition

          The portion of the identifier typically relevant to the user and which is unique within the context of the system.

          ShortThe value that is unique
          Comments

          If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

          Control10..1
          This element is affected by the following invariants: ident-1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Example<br/><b>General</b>:123456
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          54. MedicinalProductDefinition.identifier:mpId.period
          Definition

          Time period during which identifier is/was valid for use.

          ShortTime period when id is/was valid for use
          Control0..01
          TypePeriod
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          56. MedicinalProductDefinition.identifier:mpId.assigner
          Definition

          Organization that issued/manages the identifier.

          ShortOrganization that issued id (may be just text)
          Comments

          The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

          Control0..01
          TypeReference(Organization)
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          58. MedicinalProductDefinition.identifier:apiv2Id
          Slice Nameapiv2Id
          Definition

          Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.

          ShortBusiness identifier for this product. Could be an MPID
          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control0..1*
          TypeIdentifier(EMA API V2 Identifier)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Alternate NamesMPID
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          60. MedicinalProductDefinition.identifier:apiv2Id.extension
          Definition

          An Extension


          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortExtensionAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..0*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on MedicinalProductDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 62. MedicinalProductDefinition.identifier:apiv2Id.use
            Definition

            The purpose of this identifier.

            Shortusual | official | temp | secondary | old (If known)
            Comments

            Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

            Control0..01
            BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
            (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

            Identifies the purpose for this identifier, if known .

            Typecode
            Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

            Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            64. MedicinalProductDefinition.identifier:apiv2Id.type
            Definition

            A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

            ShortDescription of identifier
            Comments

            This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

            Control0..01
            BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type
            (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

            A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

            TypeCodeableConcept
            Is Modifierfalse
            Summarytrue
            Requirements

            Allows users to make use of identifiers when the identifier system is not known.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            66. MedicinalProductDefinition.identifier:apiv2Id.system
            Definition

            Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

            ShortThe namespace for the identifier value
            Comments

            Identifier.system is always case sensitive.

            Control10..1
            Typeuri
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

            There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

            Pattern Valuehttp://spor.azure-api.net/pms/api/v2
            Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            68. MedicinalProductDefinition.identifier:apiv2Id.value
            Definition

            The portion of the identifier typically relevant to the user and which is unique within the context of the system.

            ShortThe value that is unique
            Comments

            If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

            Control10..1
            This element is affected by the following invariants: ident-1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Example<br/><b>General</b>:123456
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            70. MedicinalProductDefinition.identifier:apiv2Id.period
            Definition

            Time period during which identifier is/was valid for use.

            ShortTime period when id is/was valid for use
            Control0..01
            TypePeriod
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            72. MedicinalProductDefinition.identifier:apiv2Id.assigner
            Definition

            Organization that issued/manages the identifier.

            ShortOrganization that issued id (may be just text)
            Comments

            The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

            Control0..01
            TypeReference(Organization)
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            74. MedicinalProductDefinition.type
            Definition

            Regulatory type, e.g. Investigational or Authorized.

            ShortRegulatory type, e.g. Investigational or Authorized
            Control0..1
            BindingThe codes SHALL be taken from For example codes, see Medicinal Product Typehttp://hl7.org/fhir/ValueSet/medicinal-product-type
            (required to http://ema.europa.eu/fhir/vs/medicinalProductType)
            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            76. MedicinalProductDefinition.domain
            Definition

            If this medicine applies to human or veterinary uses.

            ShortIf this medicine applies to human or veterinary uses
            Control10..1
            BindingThe codes SHALL be taken from For example codes, see Domainhttp://hl7.org/fhir/ValueSet/medicinal-product-domain
            (required to http://ema.europa.eu/fhir/vs/domain)
            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            78. MedicinalProductDefinition.version
            Definition

            A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product.

            ShortA business identifier relating to a specific version of the product
            NoteThis is a business version Id, not a resource version Id (see discussion)
            Control0..01
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            80. MedicinalProductDefinition.status
            Definition

            The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status.

            ShortThe status within the lifecycle of this product record
            Control10..1
            BindingThe codes SHALL be taken from The codes SHOULD be taken from Record Statushttp://hl7.org/fhir/ValueSet/publication-status
            (required to http://ema.europa.eu/fhir/vs/recordStatus)
            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
            Is Modifiertrue because This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            82. MedicinalProductDefinition.statusDate
            Definition

            The date at which the given status became applicable.

            ShortThe date at which the given status became applicable
            Control0..01
            TypedateTime
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            84. MedicinalProductDefinition.description
            Definition

            General description of this product.

            ShortGeneral description of this product
            Control0..01
            Typemarkdown
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            86. MedicinalProductDefinition.combinedPharmaceuticalDoseForm
            Definition

            The dose form for a single part product, or combined form of a multiple part product. This is one concept that describes all the components. It does not represent the form with components physically mixed, if that might be necessary, for which see (AdministrableProductDefinition.administrableDoseForm).

            ShortThe dose form for a single part product, or combined form of a multiple part product
            Control0..1
            BindingThe codes SHALL be taken from For example codes, see Combined Pharmaceutical Dose Formhttp://hl7.org/fhir/ValueSet/combined-dose-form
            (required to http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm)
            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            88. MedicinalProductDefinition.route
            Definition

            The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.

            ShortThe path by which the product is taken into or makes contact with the body
            Control0..0*
            BindingFor example codes, see SNOMEDCTRouteCodeshttp://hl7.org/fhir/ValueSet/route-codes
            (example to http://hl7.org/fhir/ValueSet/route-codes)

            A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            90. MedicinalProductDefinition.indication
            Definition

            Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate.

            ShortDescription of indication(s) for this product, used when structured indications are not required
            Control10..1
            Typemarkdown
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            92. MedicinalProductDefinition.indication.extension
            Definition

            Language using the EMA SPOR codes


            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

            ShortLanguage
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control1..1
            TypeExtension(Language) (Extension Type: Coding(EMA Coding))
            Is Modifierfalse
            Alternate Namesextensions, user content
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            94. MedicinalProductDefinition.legalStatusOfSupply
            Definition

            The legal status of supply of the medicinal product as classified by the regulator.

            ShortThe legal status of supply of the medicinal product as classified by the regulator
            Control10..1
            BindingThe codes SHALL be taken from For example codes, see Legal Status of Supplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supply
            (required to http://ema.europa.eu/fhir/vs/legalStatusForTheSupply)
            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            96. MedicinalProductDefinition.additionalMonitoringIndicator
            Definition

            Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.

            ShortWhether the Medicinal Product is subject to additional monitoring for regulatory reasons
            Control10..1
            BindingThe codes SHALL be taken from For example codes, see Additional Monitoring Indicatorhttp://hl7.org/fhir/ValueSet/medicinal-product-additional-monitoring
            (required to http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator)
            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            98. MedicinalProductDefinition.specialMeasures
            Definition

            Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorization studies.

            ShortWhether the Medicinal Product is subject to special measures for regulatory reasons
            Control0..0*
            BindingFor example codes, see SpecialMeasureshttp://hl7.org/fhir/ValueSet/medicinal-product-special-measures
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-special-measures)

            Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            100. MedicinalProductDefinition.pediatricUseIndicator
            Definition

            If authorised for use in children, or infants, neonates etc.

            ShortIf authorised for use in children
            Control10..1
            BindingThe codes SHALL be taken from For example codes, see Paediatric Use Indicatorhttp://hl7.org/fhir/ValueSet/medicinal-product-pediatric-use
            (required to http://ema.europa.eu/fhir/vs/paediatricUseIndicator)
            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            102. MedicinalProductDefinition.classification
            Definition

            Allows the product to be classified by various systems, commonly WHO ATC.

            ShortAllows the product to be classified by various systems
            Control10..*
            BindingFor example codes, see ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification
            (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification)

            This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.

            TypeCodeableConcept
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on MedicinalProductDefinition.classification. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
            • value @ coding.system
            • 104. MedicinalProductDefinition.classification:xevmpd
              Slice Namexevmpd
              Definition

              Allows the product to be classified by various systems, commonly WHO ATC.

              ShortAllows the product to be classified by various systems
              Control0..1*
              BindingFor example codes, see ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification
              (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification)

              This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.

              TypeCodeableConcept(EMA XEVMPD Product CodeableConcept)
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              106. MedicinalProductDefinition.classification:xevmpd.extension
              Definition

              An Extension


              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

              ShortExtensionAdditional content defined by implementations
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..0*
              TypeExtension
              Is Modifierfalse
              Summaryfalse
              Alternate Namesextensions, user content
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              SlicingThis element introduces a set of slices on MedicinalProductDefinition.classification.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 108. MedicinalProductDefinition.classification:xevmpd.text
                Definition

                A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                ShortPlain text representation of the concept
                Comments

                Very often the text is the same as a displayName of one of the codings.

                Control0..01
                Typestring
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Requirements

                The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                110. MedicinalProductDefinition.classification:legalBasis
                Slice NamelegalBasis
                Definition

                Allows the product to be classified by various systems, commonly WHO ATC.

                ShortAllows the product to be classified by various systems
                Control0..1*
                BindingFor example codes, see ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification
                (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification)

                This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.

                TypeCodeableConcept(EMA Legal Basis CodeableConcept)
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                112. MedicinalProductDefinition.classification:legalBasis.extension
                Definition

                An Extension


                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                ShortExtensionAdditional content defined by implementations
                Comments

                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                Control0..0*
                TypeExtension
                Is Modifierfalse
                Summaryfalse
                Alternate Namesextensions, user content
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                SlicingThis element introduces a set of slices on MedicinalProductDefinition.classification.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 114. MedicinalProductDefinition.classification:legalBasis.text
                  Definition

                  A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                  ShortPlain text representation of the concept
                  Comments

                  Very often the text is the same as a displayName of one of the codings.

                  Control0..01
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  116. MedicinalProductDefinition.classification:lightAtc
                  Slice NamelightAtc
                  Definition

                  Allows the product to be classified by various systems, commonly WHO ATC.

                  ShortAllows the product to be classified by various systems
                  Control10..*
                  BindingFor example codes, see ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification
                  (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification)

                  This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.

                  TypeCodeableConcept(EMA Light ATC CodeableConcept)
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  118. MedicinalProductDefinition.classification:lightAtc.extension
                  Definition

                  The ATC pending Extension


                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                  ShortThe ATC Pending Extension
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..0
                  TypeExtension(The ATC Pending Extension) (Extension Type: Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta)
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  123. MedicinalProductDefinition.classification:lightAtc.coding
                  Definition

                  A reference to a code defined by a terminology system.

                  ShortCode defined by a terminology system
                  Comments

                  Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                  Control10..1*
                  TypeCoding(EMA ATC Coding)
                  Is Modifierfalse
                  Summarytrue
                  Requirements

                  Allows for alternative encodings within a code system, and translations to other code systems.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  125. MedicinalProductDefinition.classification:lightAtc.coding.system
                  Definition

                  The identification of the code system that defines the meaning of the symbol in the code.

                  ShortIdentity of the terminology system
                  Comments

                  The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

                  Control10..1
                  Typeuri
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  Need to be unambiguous about the source of the definition of the symbol.

                  Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000093533
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  127. MedicinalProductDefinition.classification:lightAtc.coding.version
                  Definition

                  The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                  ShortVersion of the system - if relevant
                  Comments

                  Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                  NoteThis is a business version Id, not a resource version Id (see discussion)
                  Control0..01
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  129. MedicinalProductDefinition.classification:lightAtc.coding.code
                  Definition

                  A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                  ShortSymbol in syntax defined by the system
                  Control10..1
                  This element is affected by the following invariants: cod-1
                  Typecode
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  Need to refer to a particular code in the system.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  131. MedicinalProductDefinition.classification:lightAtc.coding.userSelected
                  Definition

                  Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                  ShortIf this coding was chosen directly by the user
                  Comments

                  Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                  Control0..01
                  Typeboolean
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  133. MedicinalProductDefinition.classification:lightAtc.text
                  Definition

                  A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                  ShortPlain text representation of the concept
                  Comments

                  Very often the text is the same as a displayName of one of the codings.

                  Control0..01
                  Typestring
                  Is Modifierfalse
                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                  Summarytrue
                  Requirements

                  The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  135. MedicinalProductDefinition.classification:productCategory
                  Slice NameproductCategory
                  Definition

                  Allows the product to be classified by various systems, commonly WHO ATC.

                  ShortAllows the product to be classified by various systems
                  Control0..*
                  BindingFor example codes, see ProductClassificationhttp://hl7.org/fhir/ValueSet/medicinal-product-classification
                  (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification)

                  This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.

                  TypeCodeableConcept(EMA Product Category CodeableConcept)
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  137. MedicinalProductDefinition.classification:productCategory.extension
                  Definition

                  An Extension


                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                  ShortExtensionAdditional content defined by implementations
                  Comments

                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                  Control0..0*
                  TypeExtension
                  Is Modifierfalse
                  Summaryfalse
                  Alternate Namesextensions, user content
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                  SlicingThis element introduces a set of slices on MedicinalProductDefinition.classification.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 139. MedicinalProductDefinition.classification:productCategory.text
                    Definition

                    A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                    ShortPlain text representation of the concept
                    Comments

                    Very often the text is the same as a displayName of one of the codings.

                    Control0..01
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Summarytrue
                    Requirements

                    The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    141. MedicinalProductDefinition.marketingStatus
                    Definition

                    Marketing status of the medicinal product, in contrast to marketing authorization. This refers to the product being actually 'on the market' as opposed to being allowed to be on the market (which is an authorization).

                    ShortMarketing status of the medicinal product, in contrast to marketing authorization
                    Control0..0*
                    TypeMarketingStatus
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    143. MedicinalProductDefinition.packagedMedicinalProduct
                    Definition

                    Package type for the product. See also the PackagedProductDefinition resource.

                    ShortPackage type for the product
                    Control0..0*
                    BindingFor example codes, see MedicinalProductPackageTypehttp://hl7.org/fhir/ValueSet/medicinal-product-package-type
                    (example to http://hl7.org/fhir/ValueSet/medicinal-product-package-type)

                    Types of medicinal product packs

                    TypeCodeableConcept
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    145. MedicinalProductDefinition.ingredient
                    Definition

                    The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes.

                    ShortThe ingredients of this medicinal product - when not detailed in other resources
                    Control0..0*
                    BindingFor example codes, see SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes
                    (example to http://hl7.org/fhir/ValueSet/substance-codes)

                    This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

                    TypeCodeableConcept
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    147. MedicinalProductDefinition.impurity
                    Definition

                    Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products.

                    ShortAny component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
                    Control0..0*
                    BindingFor example codes, see SNOMEDCTSubstanceCodeshttp://hl7.org/fhir/ValueSet/substance-codes
                    (example to http://hl7.org/fhir/ValueSet/substance-codes)

                    This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

                    TypeCodeableReference(SubstanceDefinition)
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    149. MedicinalProductDefinition.masterFile
                    Definition

                    A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products.

                    ShortA master file for the medicinal product (e.g. Pharmacovigilance System Master File)
                    Control10..1*
                    TypeReference(DocumentReference)
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    151. MedicinalProductDefinition.contact
                    Definition

                    A product specific contact, person (in a role), or an organization.

                    ShortA product specific contact, person (in a role), or an organization
                    Control20..2*
                    TypeBackboneElement
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    SlicingThis element introduces a set of slices on MedicinalProductDefinition.contact. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                    • value @ type.coding.code
                    • 153. MedicinalProductDefinition.contact.modifierExtension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                      ShortExtensions that cannot be ignored even if unrecognized
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..*
                      TypeExtension
                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                      Summarytrue
                      Requirements

                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                      Alternate Namesextensions, user content, modifiers
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      155. MedicinalProductDefinition.contact.contact
                      Definition

                      A product specific contact, person (in a role), or an organization.

                      ShortA product specific contact, person (in a role), or an organization
                      Control1..1
                      TypeReference(Organization, PractitionerRole)
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      157. MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact
                      Slice NamepharmacovigilanceQualifiedPersonContact
                      Definition

                      A product specific contact, person (in a role), or an organization.

                      ShortA product specific contact, person (in a role), or an organization
                      Control10..1*
                      TypeBackboneElement
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      159. MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact.modifierExtension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                      ShortExtensions that cannot be ignored even if unrecognized
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..*
                      TypeExtension
                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                      Summarytrue
                      Requirements

                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                      Alternate Namesextensions, user content, modifiers
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      161. MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact.type
                      Definition

                      Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.

                      ShortAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
                      Control0..1
                      BindingFor example codes, see ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-type
                      (example to http://hl7.org/fhir/ValueSet/medicinal-product-contact-type)

                      Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

                      TypeCodeableConcept(EMA Pharmacovigilance Qualified Person Type CodeableConcept)
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      163. MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact.contact
                      Definition

                      A product specific contact, person (in a role), or an organization.

                      ShortA product specific contact, person (in a role), or an organization
                      Control1..1
                      TypeReference(PractitionerRole, Organization)
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      165. MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact
                      Slice NamepharmacovigilanceEnquiryContact
                      Definition

                      A product specific contact, person (in a role), or an organization.

                      ShortA product specific contact, person (in a role), or an organization
                      Control10..1*
                      TypeBackboneElement
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      167. MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact.modifierExtension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                      ShortExtensions that cannot be ignored even if unrecognized
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..*
                      TypeExtension
                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                      Summarytrue
                      Requirements

                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                      Alternate Namesextensions, user content, modifiers
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      169. MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact.type
                      Definition

                      Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.

                      ShortAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
                      Control0..1
                      BindingFor example codes, see ProductContactTypehttp://hl7.org/fhir/ValueSet/medicinal-product-contact-type
                      (example to http://hl7.org/fhir/ValueSet/medicinal-product-contact-type)

                      Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

                      TypeCodeableConcept(EMA Pharmacovigilance Qualified Person Type CodeableConcept)
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      171. MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact.contact
                      Definition

                      A product specific contact, person (in a role), or an organization.

                      ShortA product specific contact, person (in a role), or an organization
                      Control1..1
                      TypeReference(Organization, PractitionerRole)
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      173. MedicinalProductDefinition.code
                      Definition

                      A code that this product is known by, usually within some formal terminology, perhaps assigned by a third party (i.e. not the manufacturer or regulator). Products (types of medications) tend to be known by identifiers during development and within regulatory process. However when they are prescribed they tend to be identified by codes. The same product may be have multiple codes, applied to it by multiple organizations.

                      ShortA code that this product is known by, within some formal terminology
                      Control0..0*
                      BindingFor example codes, see SNOMEDCTMedicationCodeshttp://hl7.org/fhir/ValueSet/medication-codes
                      (example to http://hl7.org/fhir/ValueSet/medication-codes)

                      A coded concept that defines the type of a medication.

                      TypeCoding
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      175. MedicinalProductDefinition.name
                      Definition

                      The product's name, including full name and possibly coded parts.

                      ShortThe product's name, including full name and possibly coded parts
                      Control1..1*
                      TypeBackboneElement
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      177. MedicinalProductDefinition.name.modifierExtension
                      Definition

                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                      ShortExtensions that cannot be ignored even if unrecognized
                      Comments

                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                      Control0..*
                      TypeExtension
                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                      Summarytrue
                      Requirements

                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                      Alternate Namesextensions, user content, modifiers
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                      179. MedicinalProductDefinition.name.productName
                      Definition

                      The full product name.

                      ShortThe full product name
                      Control1..1
                      Typestring
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      181. MedicinalProductDefinition.name.type
                      Definition

                      Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.

                      ShortType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
                      Control0..1
                      BindingThe codes SHALL be taken from For example codes, see Medicinal Product Name Part Typehttp://hl7.org/fhir/ValueSet/medicinal-product-name-type
                      (required to http://ema.europa.eu/fhir/vs/productNamePartType)
                      TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      183. MedicinalProductDefinition.name.part
                      Definition

                      Coding words or phrases of the name.

                      ShortCoding words or phrases of the name
                      Control10..*
                      TypeBackboneElement
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      SlicingThis element introduces a set of slices on MedicinalProductDefinition.name.part. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ type
                      • 185. MedicinalProductDefinition.name.part.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        Requirements

                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        187. MedicinalProductDefinition.name.part.part
                        Definition

                        A fragment of a product name.

                        ShortA fragment of a product name
                        Control1..1
                        Typestring
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        189. MedicinalProductDefinition.name.part.type
                        Definition

                        Identifying type for this part of the name (e.g. strength part).

                        ShortIdentifying type for this part of the name (e.g. strength part)
                        Control1..1
                        BindingFor example codes, see ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
                        (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                        Type of part of a name for a Medicinal Product.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        191. MedicinalProductDefinition.name.part.type.coding
                        Definition

                        A reference to a code defined by a terminology system.

                        ShortCode defined by a terminology system
                        Comments

                        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                        Control0..*
                        BindingThe codes SHALL be taken from For codes, see Medicinal Product Name Part Type
                        (required to http://ema.europa.eu/fhir/vs/productNamePartType)
                        TypeCoding(The MPD Name Part Type Coding)
                        Is Modifierfalse
                        Summarytrue
                        Requirements

                        Allows for alternative encodings within a code system, and translations to other code systems.

                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        193. MedicinalProductDefinition.name.part:inventedName
                        Slice NameinventedName
                        Definition

                        Coding words or phrases of the name.

                        ShortCoding words or phrases of the name
                        Control0..1*
                        TypeBackboneElement
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        195. MedicinalProductDefinition.name.part:inventedName.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        Requirements

                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        197. MedicinalProductDefinition.name.part:inventedName.part
                        Definition

                        A fragment of a product name.

                        ShortA fragment of a product name
                        Control1..1
                        Typestring
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        199. MedicinalProductDefinition.name.part:inventedName.type
                        Definition

                        Identifying type for this part of the name (e.g. strength part).

                        ShortIdentifying type for this part of the name (e.g. strength part)
                        Control1..1
                        BindingFor example codes, see ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
                        (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                        Type of part of a name for a Medicinal Product.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Pattern Value{
                          "coding" : [{
                            "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                            "code" : "220000000002"
                          }]
                        }
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        201. MedicinalProductDefinition.name.part:fullName
                        Slice NamefullName
                        Definition

                        Coding words or phrases of the name.

                        ShortCoding words or phrases of the name
                        Control0..1*
                        TypeBackboneElement
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        203. MedicinalProductDefinition.name.part:fullName.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        Requirements

                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        205. MedicinalProductDefinition.name.part:fullName.part
                        Definition

                        A fragment of a product name.

                        ShortA fragment of a product name
                        Control1..1
                        Typestring
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        207. MedicinalProductDefinition.name.part:fullName.type
                        Definition

                        Identifying type for this part of the name (e.g. strength part).

                        ShortIdentifying type for this part of the name (e.g. strength part)
                        Control1..1
                        BindingFor example codes, see ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
                        (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                        Type of part of a name for a Medicinal Product.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Pattern Value{
                          "coding" : [{
                            "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                            "code" : "220000000001"
                          }]
                        }
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        209. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm
                        Slice NamepharmaceuticalDoseForm
                        Definition

                        Coding words or phrases of the name.

                        ShortCoding words or phrases of the name
                        Control0..1*
                        TypeBackboneElement
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        211. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        Requirements

                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        213. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.part
                        Definition

                        A fragment of a product name.

                        ShortA fragment of a product name
                        Control1..1
                        Typestring
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        215. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type
                        Definition

                        Identifying type for this part of the name (e.g. strength part).

                        ShortIdentifying type for this part of the name (e.g. strength part)
                        Control1..1
                        BindingFor example codes, see ProductNamePartTypehttp://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
                        (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                        Type of part of a name for a Medicinal Product.

                        TypeCodeableConcept
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Pattern Value{
                          "coding" : [{
                            "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                            "code" : "220000000005"
                          }]
                        }
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        217. MedicinalProductDefinition.name.usage
                        Definition

                        Country and jurisdiction where the name applies, and associated language.

                        ShortCountry and jurisdiction where the name applies
                        Control10..1*
                        TypeBackboneElement
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        219. MedicinalProductDefinition.name.usage.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        Requirements

                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        221. MedicinalProductDefinition.name.usage.country
                        Definition

                        Country code for where this name applies.

                        ShortCountry code for where this name applies
                        Control1..1
                        BindingThe codes SHALL be taken from For example codes, see Countryhttp://hl7.org/fhir/ValueSet/country
                        (required to http://ema.europa.eu/fhir/vs/country)
                        TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        223. MedicinalProductDefinition.name.usage.language
                        Definition

                        Language code for this name.

                        ShortLanguage code for this name
                        Control1..1
                        BindingThe codes SHALL be taken from Languagehttp://hl7.org/fhir/ValueSet/all-languages|5.0.0
                        (required to http://ema.europa.eu/fhir/vs/language)
                        TypeCodeableConcept
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        225. MedicinalProductDefinition.crossReference
                        Definition

                        Reference to another product, e.g. for linking authorised to investigational product, or a virtual product.

                        ShortReference to another product, e.g. for linking authorised to investigational product
                        Control0..1*
                        TypeBackboneElement
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        227. MedicinalProductDefinition.crossReference.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        Requirements

                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        229. MedicinalProductDefinition.crossReference.product
                        Definition

                        Reference to another product, e.g. for linking authorised to investigational product.

                        ShortReference to another product, e.g. for linking authorised to investigational product
                        Control1..1
                        TypeCodeableReference(MedicinalProductDefinition)
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        231. MedicinalProductDefinition.crossReference.type
                        Definition

                        The type of relationship, for instance branded to generic, virtual to actual product, product to development product (investigational), parallel import version.

                        ShortThe type of relationship, for instance branded to generic or virtual to actual product
                        Control10..1
                        BindingThe codes SHALL be taken from For example codes, see Product Cross Reference Typehttp://hl7.org/fhir/ValueSet/medicinal-product-cross-reference-type
                        (required to http://ema.europa.eu/fhir/vs/productcrossreferencetype)
                        TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        233. MedicinalProductDefinition.characteristic
                        Definition

                        Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import".

                        ShortKey product features such as "sugar free", "modified release"
                        Control10..1*
                        TypeBackboneElement
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        235. MedicinalProductDefinition.characteristic.modifierExtension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                        Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                        ShortExtensions that cannot be ignored even if unrecognized
                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control0..*
                        TypeExtension
                        Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                        Summarytrue
                        Requirements

                        Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                        Alternate Namesextensions, user content, modifiers
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        237. MedicinalProductDefinition.characteristic.type
                        Definition

                        A code expressing the type of characteristic.

                        ShortA code expressing the type of characteristic
                        Control1..1
                        BindingFor example codes, see ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes
                        (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

                        This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

                        TypeCodeableConcept(EMA Genetically Modified Organisms CodeableConcept)
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

                        Guidance on how to interpret the contents of this table can be found here

                        0. MedicinalProductDefinition
                        2. MedicinalProductDefinition.extension
                        Definition

                        May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                        Comments

                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                        Control1..
                        TypeExtension(Authorised Dose Form) (Extension Type: Coding(EMA Coding))
                        Alternate Namesextensions, user content
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        4. MedicinalProductDefinition.identifier
                        NoteThis is a business identifier, not a resource identifier (see discussion)
                        Control0..3
                        SlicingThis element introduces a set of slices on MedicinalProductDefinition.identifier. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                        • value @ system
                        • 6. MedicinalProductDefinition.identifier.extension
                          Control0..0
                          8. MedicinalProductDefinition.identifier.use
                          Control0..0
                          10. MedicinalProductDefinition.identifier.type
                          Control0..0
                          12. MedicinalProductDefinition.identifier.period
                          Control0..0
                          14. MedicinalProductDefinition.identifier.assigner
                          Control0..0
                          16. MedicinalProductDefinition.identifier:eurdId
                          Slice NameeurdId
                          NoteThis is a business identifier, not a resource identifier (see discussion)
                          Control0..1
                          TypeIdentifier(EMA EURD Identifier)
                          18. MedicinalProductDefinition.identifier:eurdId.system
                          Control1..?
                          Pattern Valuehttp://ema.europa.eu/fhir/eurdId
                          20. MedicinalProductDefinition.identifier:mpId
                          Slice NamempId
                          NoteThis is a business identifier, not a resource identifier (see discussion)
                          Control0..1
                          TypeIdentifier(EMA MP Identifier)
                          22. MedicinalProductDefinition.identifier:mpId.system
                          Control1..?
                          Pattern Valuehttp://ema.europa.eu/fhir/mpId
                          24. MedicinalProductDefinition.identifier:apiv2Id
                          Slice Nameapiv2Id
                          NoteThis is a business identifier, not a resource identifier (see discussion)
                          Control0..1
                          TypeIdentifier(EMA API V2 Identifier)
                          26. MedicinalProductDefinition.identifier:apiv2Id.system
                          Control1..?
                          Pattern Valuehttp://spor.azure-api.net/pms/api/v2
                          28. MedicinalProductDefinition.type
                          BindingThe codes SHALL be taken from Medicinal Product Type
                          (required to http://ema.europa.eu/fhir/vs/medicinalProductType)
                          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                          30. MedicinalProductDefinition.domain
                          Control1..?
                          BindingThe codes SHALL be taken from Domain
                          (required to http://ema.europa.eu/fhir/vs/domain)
                          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                          32. MedicinalProductDefinition.status
                          Control1..?
                          BindingThe codes SHALL be taken from Record Status
                          (required to http://ema.europa.eu/fhir/vs/recordStatus)
                          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                          34. MedicinalProductDefinition.combinedPharmaceuticalDoseForm
                          BindingThe codes SHALL be taken from Combined Pharmaceutical Dose Form
                          (required to http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm)
                          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                          36. MedicinalProductDefinition.indication
                          Control1..?
                          38. MedicinalProductDefinition.indication.extension
                          Control1..1
                          TypeExtension(Language) (Extension Type: Coding(EMA Coding))
                          40. MedicinalProductDefinition.legalStatusOfSupply
                          Control1..?
                          BindingThe codes SHALL be taken from Legal Status of Supply
                          (required to http://ema.europa.eu/fhir/vs/legalStatusForTheSupply)
                          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                          42. MedicinalProductDefinition.additionalMonitoringIndicator
                          Control1..?
                          BindingThe codes SHALL be taken from Additional Monitoring Indicator
                          (required to http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator)
                          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                          44. MedicinalProductDefinition.pediatricUseIndicator
                          Control1..?
                          BindingThe codes SHALL be taken from Paediatric Use Indicator
                          (required to http://ema.europa.eu/fhir/vs/paediatricUseIndicator)
                          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                          46. MedicinalProductDefinition.classification
                          Control1..?
                          SlicingThis element introduces a set of slices on MedicinalProductDefinition.classification. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                          • value @ coding.system
                          • 48. MedicinalProductDefinition.classification:xevmpd
                            Slice Namexevmpd
                            Control0..1
                            TypeCodeableConcept(EMA XEVMPD Product CodeableConcept)
                            50. MedicinalProductDefinition.classification:xevmpd.coding
                            52. MedicinalProductDefinition.classification:xevmpd.coding.system
                            Control1..?
                            Pattern Valuehttp://spor.ema.europa.eu/v1/lists/200000000324
                            54. MedicinalProductDefinition.classification:legalBasis
                            Slice NamelegalBasis
                            Control0..1
                            TypeCodeableConcept(EMA Legal Basis CodeableConcept)
                            56. MedicinalProductDefinition.classification:legalBasis.coding
                            58. MedicinalProductDefinition.classification:legalBasis.coding.system
                            Control1..?
                            Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000116045
                            60. MedicinalProductDefinition.classification:lightAtc
                            Slice NamelightAtc
                            Control1..*
                            TypeCodeableConcept(EMA Light ATC CodeableConcept)
                            62. MedicinalProductDefinition.classification:lightAtc.coding
                            64. MedicinalProductDefinition.classification:lightAtc.coding.system
                            Control1..?
                            Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000093533
                            66. MedicinalProductDefinition.classification:productCategory
                            Slice NameproductCategory
                            Control0..*
                            TypeCodeableConcept(EMA Product Category CodeableConcept)
                            68. MedicinalProductDefinition.classification:productCategory.coding
                            70. MedicinalProductDefinition.classification:productCategory.coding.system
                            Control1..?
                            Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000155526
                            72. MedicinalProductDefinition.masterFile
                            Control1..1
                            74. MedicinalProductDefinition.contact
                            Control2..2
                            SlicingThis element introduces a set of slices on MedicinalProductDefinition.contact. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                            • value @ type.coding.code
                            • 76. MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact
                              Slice NamepharmacovigilanceQualifiedPersonContact
                              Control1..1
                              78. MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact.type
                              TypeCodeableConcept(EMA Pharmacovigilance Qualified Person Type CodeableConcept)
                              80. MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact.contact
                              TypeReference(PractitionerRole)
                              82. MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact
                              Slice NamepharmacovigilanceEnquiryContact
                              Control1..1
                              84. MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact.type
                              TypeCodeableConcept(EMA Pharmacovigilance Qualified Person Type CodeableConcept)
                              86. MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact.contact
                              TypeReference(Organization)
                              88. MedicinalProductDefinition.name
                              Control0..1
                              90. MedicinalProductDefinition.name.type
                              BindingThe codes SHALL be taken from Medicinal Product Name Part Type
                              (required to http://ema.europa.eu/fhir/vs/productNamePartType)
                              TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                              92. MedicinalProductDefinition.name.part
                              Control1..?
                              SlicingThis element introduces a set of slices on MedicinalProductDefinition.name.part. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • value @ type
                              • 94. MedicinalProductDefinition.name.part.type
                                96. MedicinalProductDefinition.name.part.type.coding
                                BindingThe codes SHALL be taken from Medicinal Product Name Part Type
                                (required to http://ema.europa.eu/fhir/vs/productNamePartType)
                                TypeCoding(The MPD Name Part Type Coding)
                                98. MedicinalProductDefinition.name.part:inventedName
                                Slice NameinventedName
                                Control0..1
                                100. MedicinalProductDefinition.name.part:inventedName.type
                                Pattern Value{
                                  "coding" : [{
                                    "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                                    "code" : "220000000002"
                                  }]
                                }
                                102. MedicinalProductDefinition.name.part:fullName
                                Slice NamefullName
                                Control0..1
                                104. MedicinalProductDefinition.name.part:fullName.type
                                Pattern Value{
                                  "coding" : [{
                                    "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                                    "code" : "220000000001"
                                  }]
                                }
                                106. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm
                                Slice NamepharmaceuticalDoseForm
                                Control0..1
                                108. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type
                                Pattern Value{
                                  "coding" : [{
                                    "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                                    "code" : "220000000005"
                                  }]
                                }
                                110. MedicinalProductDefinition.name.usage
                                Control1..1
                                112. MedicinalProductDefinition.name.usage.country
                                BindingThe codes SHALL be taken from Country
                                (required to http://ema.europa.eu/fhir/vs/country)
                                TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                114. MedicinalProductDefinition.name.usage.language
                                BindingThe codes SHALL be taken from Language
                                (required to http://ema.europa.eu/fhir/vs/language)
                                116. MedicinalProductDefinition.crossReference
                                Control0..1
                                118. MedicinalProductDefinition.crossReference.product
                                120. MedicinalProductDefinition.crossReference.product.reference
                                122. MedicinalProductDefinition.crossReference.product.reference.identifier
                                NoteThis is a business identifier, not a resource identifier (see discussion)
                                Control1..?
                                124. MedicinalProductDefinition.crossReference.product.reference.identifier.system
                                Pattern Valuehttp://ema.europa.eu/fhir/crossReference
                                126. MedicinalProductDefinition.crossReference.type
                                Control1..?
                                BindingThe codes SHALL be taken from Product Cross Reference Type
                                (required to http://ema.europa.eu/fhir/vs/productcrossreferencetype)
                                TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                128. MedicinalProductDefinition.operation
                                130. MedicinalProductDefinition.operation.type
                                TypeCodeableReference(EMA Write API ActivityDefinition)
                                132. MedicinalProductDefinition.operation.confidentialityIndicator
                                BindingThe codes SHALL be taken from Data Classification
                                (required to http://ema.europa.eu/fhir/vs/dataClassification)
                                TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                134. MedicinalProductDefinition.characteristic
                                Control1..1
                                136. MedicinalProductDefinition.characteristic.type
                                TypeCodeableConcept(EMA Genetically Modified Organisms CodeableConcept)

                                Guidance on how to interpret the contents of this table can be found here

                                0. MedicinalProductDefinition
                                Definition

                                A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).

                                ShortDetailed definition of a medicinal product
                                Control0..*
                                Is Modifierfalse
                                Must Supportfalse
                                Summaryfalse
                                Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
                                dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource (contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty())
                                dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
                                dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
                                dom-6: A resource should have narrative for robust management (text.`div`.exists())
                                2. MedicinalProductDefinition.id
                                Definition

                                The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

                                ShortLogical id of this artifact
                                Comments

                                Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.

                                Control0..1
                                Typeid
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                4. MedicinalProductDefinition.meta
                                Definition

                                The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.

                                ShortMetadata about the resource
                                Control0..1
                                TypeMeta
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                6. MedicinalProductDefinition.implicitRules
                                Definition

                                A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.

                                ShortA set of rules under which this content was created
                                Comments

                                Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.

                                Control0..0
                                Typeuri
                                Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                8. MedicinalProductDefinition.language
                                Definition

                                The base language in which the resource is written.

                                ShortLanguage of the resource content
                                Comments

                                Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).

                                Control0..0
                                BindingThe codes SHALL be taken from AllLanguages
                                (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                                IETF language tag for a human language

                                Typecode
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Must Supportfalse
                                Summaryfalse
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                10. MedicinalProductDefinition.text
                                Definition

                                A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.

                                ShortText summary of the resource, for human interpretation
                                Comments

                                Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.

                                Control0..0
                                This element is affected by the following invariants: dom-6
                                TypeNarrative
                                Is Modifierfalse
                                Must Supportfalse
                                Summaryfalse
                                Alternate Namesnarrative, html, xhtml, display
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                12. MedicinalProductDefinition.contained
                                Definition

                                These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.

                                ShortContained, inline Resources
                                Comments

                                This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.

                                Control0..0
                                This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
                                TypeResource
                                Is Modifierfalse
                                Must Supportfalse
                                Summaryfalse
                                Alternate Namesinline resources, anonymous resources, contained resources
                                14. MedicinalProductDefinition.extension
                                Definition

                                Authorised Dose Form

                                ShortAuthorised Dose Form
                                Control1..*
                                TypeExtension(Authorised Dose Form) (Extension Type: Coding(EMA Coding))
                                Is Modifierfalse
                                Must Supportfalse
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                16. MedicinalProductDefinition.modifierExtension
                                Definition

                                An Extension

                                ShortExtension
                                Control0..0
                                TypeExtension
                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                18. MedicinalProductDefinition.identifier
                                Definition

                                Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.

                                ShortBusiness identifier for this product. Could be an MPID
                                NoteThis is a business identifier, not a resource identifier (see discussion)
                                Control0..3
                                TypeIdentifier
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Alternate NamesMPID
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                SlicingThis element introduces a set of slices on MedicinalProductDefinition.identifier. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                • value @ system
                                • 20. MedicinalProductDefinition.identifier.id
                                  Definition

                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                  ShortUnique id for inter-element referencing
                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  Typeid
                                  Is Modifierfalse
                                  XML FormatIn the XML format, this property is represented as an attribute.
                                  Summaryfalse
                                  22. MedicinalProductDefinition.identifier.extension
                                  Definition

                                  An Extension

                                  ShortExtension
                                  Control0..0
                                  TypeExtension
                                  Is Modifierfalse
                                  Summaryfalse
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                  SlicingThis element introduces a set of slices on MedicinalProductDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                  • value @ url
                                  • 24. MedicinalProductDefinition.identifier.use
                                    Definition

                                    The purpose of this identifier.

                                    Shortusual | official | temp | secondary | old (If known)
                                    Comments

                                    Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                                    Control0..0
                                    BindingThe codes SHALL be taken from IdentifierUse
                                    (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

                                    Identifies the purpose for this identifier, if known .

                                    Typecode
                                    Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Requirements

                                    Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    26. MedicinalProductDefinition.identifier.type
                                    Definition

                                    A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                                    ShortDescription of identifier
                                    Comments

                                    This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

                                    Control0..0
                                    BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
                                    (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

                                    A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Summarytrue
                                    Requirements

                                    Allows users to make use of identifiers when the identifier system is not known.

                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    28. MedicinalProductDefinition.identifier.system
                                    Definition

                                    Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

                                    ShortThe namespace for the identifier value
                                    Comments

                                    Identifier.system is always case sensitive.

                                    Control0..1
                                    Typeuri
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Requirements

                                    There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

                                    Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    30. MedicinalProductDefinition.identifier.value
                                    Definition

                                    The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                                    ShortThe value that is unique
                                    Comments

                                    If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

                                    Control0..1
                                    This element is affected by the following invariants: ident-1
                                    Typestring
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Example<br/><b>General</b>:123456
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    32. MedicinalProductDefinition.identifier.period
                                    Definition

                                    Time period during which identifier is/was valid for use.

                                    ShortTime period when id is/was valid for use
                                    Control0..0
                                    TypePeriod
                                    Is Modifierfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    34. MedicinalProductDefinition.identifier.assigner
                                    Definition

                                    Organization that issued/manages the identifier.

                                    ShortOrganization that issued id (may be just text)
                                    Comments

                                    The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

                                    Control0..0
                                    TypeReference(Organization)
                                    Is Modifierfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    36. MedicinalProductDefinition.identifier:eurdId
                                    Slice NameeurdId
                                    Definition

                                    Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.

                                    ShortBusiness identifier for this product. Could be an MPID
                                    NoteThis is a business identifier, not a resource identifier (see discussion)
                                    Control0..1
                                    TypeIdentifier(EMA EURD Identifier)
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Alternate NamesMPID
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    38. MedicinalProductDefinition.identifier:eurdId.id
                                    Definition

                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                    ShortUnique id for inter-element referencing
                                    Control0..1
                                    This element is affected by the following invariants: ele-1
                                    Typeid
                                    Is Modifierfalse
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    Summaryfalse
                                    40. MedicinalProductDefinition.identifier:eurdId.extension
                                    Definition

                                    An Extension

                                    ShortExtension
                                    Control0..0
                                    TypeExtension
                                    Is Modifierfalse
                                    Summaryfalse
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                    SlicingThis element introduces a set of slices on MedicinalProductDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                    • value @ url
                                    • 42. MedicinalProductDefinition.identifier:eurdId.use
                                      Definition

                                      The purpose of this identifier.

                                      Shortusual | official | temp | secondary | old (If known)
                                      Comments

                                      Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                                      Control0..0
                                      BindingThe codes SHALL be taken from IdentifierUse
                                      (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

                                      Identifies the purpose for this identifier, if known .

                                      Typecode
                                      Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Requirements

                                      Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      44. MedicinalProductDefinition.identifier:eurdId.type
                                      Definition

                                      A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                                      ShortDescription of identifier
                                      Comments

                                      This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

                                      Control0..0
                                      BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
                                      (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

                                      A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Summarytrue
                                      Requirements

                                      Allows users to make use of identifiers when the identifier system is not known.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      46. MedicinalProductDefinition.identifier:eurdId.system
                                      Definition

                                      Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

                                      ShortThe namespace for the identifier value
                                      Comments

                                      Identifier.system is always case sensitive.

                                      Control1..1
                                      Typeuri
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Requirements

                                      There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

                                      Pattern Valuehttp://ema.europa.eu/fhir/eurdId
                                      Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      48. MedicinalProductDefinition.identifier:eurdId.value
                                      Definition

                                      The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                                      ShortThe value that is unique
                                      Comments

                                      If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

                                      Control1..1
                                      This element is affected by the following invariants: ident-1
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Example<br/><b>General</b>:123456
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      50. MedicinalProductDefinition.identifier:eurdId.period
                                      Definition

                                      Time period during which identifier is/was valid for use.

                                      ShortTime period when id is/was valid for use
                                      Control0..0
                                      TypePeriod
                                      Is Modifierfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      52. MedicinalProductDefinition.identifier:eurdId.assigner
                                      Definition

                                      Organization that issued/manages the identifier.

                                      ShortOrganization that issued id (may be just text)
                                      Comments

                                      The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

                                      Control0..0
                                      TypeReference(Organization)
                                      Is Modifierfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      54. MedicinalProductDefinition.identifier:mpId
                                      Slice NamempId
                                      Definition

                                      Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.

                                      ShortBusiness identifier for this product. Could be an MPID
                                      NoteThis is a business identifier, not a resource identifier (see discussion)
                                      Control0..1
                                      TypeIdentifier(EMA MP Identifier)
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Alternate NamesMPID
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      56. MedicinalProductDefinition.identifier:mpId.id
                                      Definition

                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                      ShortUnique id for inter-element referencing
                                      Control0..1
                                      This element is affected by the following invariants: ele-1
                                      Typeid
                                      Is Modifierfalse
                                      XML FormatIn the XML format, this property is represented as an attribute.
                                      Summaryfalse
                                      58. MedicinalProductDefinition.identifier:mpId.extension
                                      Definition

                                      An Extension

                                      ShortExtension
                                      Control0..0
                                      TypeExtension
                                      Is Modifierfalse
                                      Summaryfalse
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                      SlicingThis element introduces a set of slices on MedicinalProductDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                      • value @ url
                                      • 60. MedicinalProductDefinition.identifier:mpId.use
                                        Definition

                                        The purpose of this identifier.

                                        Shortusual | official | temp | secondary | old (If known)
                                        Comments

                                        Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                                        Control0..0
                                        BindingThe codes SHALL be taken from IdentifierUse
                                        (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

                                        Identifies the purpose for this identifier, if known .

                                        Typecode
                                        Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Summarytrue
                                        Requirements

                                        Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        62. MedicinalProductDefinition.identifier:mpId.type
                                        Definition

                                        A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                                        ShortDescription of identifier
                                        Comments

                                        This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

                                        Control0..0
                                        BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
                                        (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

                                        A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                                        TypeCodeableConcept
                                        Is Modifierfalse
                                        Summarytrue
                                        Requirements

                                        Allows users to make use of identifiers when the identifier system is not known.

                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        64. MedicinalProductDefinition.identifier:mpId.system
                                        Definition

                                        Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

                                        ShortThe namespace for the identifier value
                                        Comments

                                        Identifier.system is always case sensitive.

                                        Control1..1
                                        Typeuri
                                        Is Modifierfalse
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Summarytrue
                                        Requirements

                                        There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

                                        Pattern Valuehttp://ema.europa.eu/fhir/mpId
                                        Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        66. MedicinalProductDefinition.identifier:mpId.value
                                        Definition

                                        The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                                        ShortThe value that is unique
                                        Comments

                                        If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

                                        Control1..1
                                        This element is affected by the following invariants: ident-1
                                        Typestring
                                        Is Modifierfalse
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Summarytrue
                                        Example<br/><b>General</b>:123456
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        68. MedicinalProductDefinition.identifier:mpId.period
                                        Definition

                                        Time period during which identifier is/was valid for use.

                                        ShortTime period when id is/was valid for use
                                        Control0..0
                                        TypePeriod
                                        Is Modifierfalse
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        70. MedicinalProductDefinition.identifier:mpId.assigner
                                        Definition

                                        Organization that issued/manages the identifier.

                                        ShortOrganization that issued id (may be just text)
                                        Comments

                                        The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

                                        Control0..0
                                        TypeReference(Organization)
                                        Is Modifierfalse
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        72. MedicinalProductDefinition.identifier:apiv2Id
                                        Slice Nameapiv2Id
                                        Definition

                                        Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.

                                        ShortBusiness identifier for this product. Could be an MPID
                                        NoteThis is a business identifier, not a resource identifier (see discussion)
                                        Control0..1
                                        TypeIdentifier(EMA API V2 Identifier)
                                        Is Modifierfalse
                                        Must Supportfalse
                                        Summarytrue
                                        Alternate NamesMPID
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        74. MedicinalProductDefinition.identifier:apiv2Id.id
                                        Definition

                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                        ShortUnique id for inter-element referencing
                                        Control0..1
                                        This element is affected by the following invariants: ele-1
                                        Typeid
                                        Is Modifierfalse
                                        XML FormatIn the XML format, this property is represented as an attribute.
                                        Summaryfalse
                                        76. MedicinalProductDefinition.identifier:apiv2Id.extension
                                        Definition

                                        An Extension

                                        ShortExtension
                                        Control0..0
                                        TypeExtension
                                        Is Modifierfalse
                                        Summaryfalse
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        SlicingThis element introduces a set of slices on MedicinalProductDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                        • value @ url
                                        • 78. MedicinalProductDefinition.identifier:apiv2Id.use
                                          Definition

                                          The purpose of this identifier.

                                          Shortusual | official | temp | secondary | old (If known)
                                          Comments

                                          Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                                          Control0..0
                                          BindingThe codes SHALL be taken from IdentifierUse
                                          (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

                                          Identifies the purpose for this identifier, if known .

                                          Typecode
                                          Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          80. MedicinalProductDefinition.identifier:apiv2Id.type
                                          Definition

                                          A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                                          ShortDescription of identifier
                                          Comments

                                          This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

                                          Control0..0
                                          BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
                                          (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

                                          A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Summarytrue
                                          Requirements

                                          Allows users to make use of identifiers when the identifier system is not known.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          82. MedicinalProductDefinition.identifier:apiv2Id.system
                                          Definition

                                          Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

                                          ShortThe namespace for the identifier value
                                          Comments

                                          Identifier.system is always case sensitive.

                                          Control1..1
                                          Typeuri
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

                                          Pattern Valuehttp://spor.azure-api.net/pms/api/v2
                                          Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          84. MedicinalProductDefinition.identifier:apiv2Id.value
                                          Definition

                                          The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                                          ShortThe value that is unique
                                          Comments

                                          If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

                                          Control1..1
                                          This element is affected by the following invariants: ident-1
                                          Typestring
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Example<br/><b>General</b>:123456
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          86. MedicinalProductDefinition.identifier:apiv2Id.period
                                          Definition

                                          Time period during which identifier is/was valid for use.

                                          ShortTime period when id is/was valid for use
                                          Control0..0
                                          TypePeriod
                                          Is Modifierfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          88. MedicinalProductDefinition.identifier:apiv2Id.assigner
                                          Definition

                                          Organization that issued/manages the identifier.

                                          ShortOrganization that issued id (may be just text)
                                          Comments

                                          The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

                                          Control0..0
                                          TypeReference(Organization)
                                          Is Modifierfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          90. MedicinalProductDefinition.type
                                          Definition

                                          Regulatory type, e.g. Investigational or Authorized.

                                          ShortRegulatory type, e.g. Investigational or Authorized
                                          Control0..1
                                          BindingThe codes SHALL be taken from Medicinal Product Type
                                          (required to http://ema.europa.eu/fhir/vs/medicinalProductType)
                                          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          92. MedicinalProductDefinition.domain
                                          Definition

                                          If this medicine applies to human or veterinary uses.

                                          ShortIf this medicine applies to human or veterinary uses
                                          Control1..1
                                          BindingThe codes SHALL be taken from Domain
                                          (required to http://ema.europa.eu/fhir/vs/domain)
                                          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          94. MedicinalProductDefinition.version
                                          Definition

                                          A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product.

                                          ShortA business identifier relating to a specific version of the product
                                          NoteThis is a business version Id, not a resource version Id (see discussion)
                                          Control0..0
                                          Typestring
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          96. MedicinalProductDefinition.status
                                          Definition

                                          The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status.

                                          ShortThe status within the lifecycle of this product record
                                          Control1..1
                                          BindingThe codes SHALL be taken from Record Status
                                          (required to http://ema.europa.eu/fhir/vs/recordStatus)
                                          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                          Is Modifiertrue because This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          98. MedicinalProductDefinition.statusDate
                                          Definition

                                          The date at which the given status became applicable.

                                          ShortThe date at which the given status became applicable
                                          Control0..0
                                          TypedateTime
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          100. MedicinalProductDefinition.description
                                          Definition

                                          General description of this product.

                                          ShortGeneral description of this product
                                          Control0..0
                                          Typemarkdown
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          102. MedicinalProductDefinition.combinedPharmaceuticalDoseForm
                                          Definition

                                          The dose form for a single part product, or combined form of a multiple part product. This is one concept that describes all the components. It does not represent the form with components physically mixed, if that might be necessary, for which see (AdministrableProductDefinition.administrableDoseForm).

                                          ShortThe dose form for a single part product, or combined form of a multiple part product
                                          Control0..1
                                          BindingThe codes SHALL be taken from Combined Pharmaceutical Dose Form
                                          (required to http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm)
                                          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          104. MedicinalProductDefinition.route
                                          Definition

                                          The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.

                                          ShortThe path by which the product is taken into or makes contact with the body
                                          Control0..0
                                          BindingFor example codes, see SNOMEDCTRouteCodes
                                          (example to http://hl7.org/fhir/ValueSet/route-codes)

                                          A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          106. MedicinalProductDefinition.indication
                                          Definition

                                          Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate.

                                          ShortDescription of indication(s) for this product, used when structured indications are not required
                                          Control1..1
                                          Typemarkdown
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          108. MedicinalProductDefinition.indication.id
                                          Definition

                                          unique id for the element within a resource (for internal references)

                                          Shortxml:id (or equivalent in JSON)
                                          Control0..1
                                          Typestring
                                          Is Modifierfalse
                                          XML FormatIn the XML format, this property is represented as an attribute.
                                          Summaryfalse
                                          110. MedicinalProductDefinition.indication.extension
                                          Definition

                                          Language using the EMA SPOR codes

                                          ShortLanguage
                                          Control1..1
                                          TypeExtension(Language) (Extension Type: Coding(EMA Coding))
                                          Is Modifierfalse
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                          112. MedicinalProductDefinition.indication.value
                                          Definition

                                          Primitive value for markdown

                                          ShortPrimitive value for markdown
                                          Control0..1
                                          Typemarkdown
                                          Is Modifierfalse
                                          XML FormatIn the XML format, this property is represented as an attribute.
                                          Summaryfalse
                                          114. MedicinalProductDefinition.legalStatusOfSupply
                                          Definition

                                          The legal status of supply of the medicinal product as classified by the regulator.

                                          ShortThe legal status of supply of the medicinal product as classified by the regulator
                                          Control1..1
                                          BindingThe codes SHALL be taken from Legal Status of Supply
                                          (required to http://ema.europa.eu/fhir/vs/legalStatusForTheSupply)
                                          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          116. MedicinalProductDefinition.additionalMonitoringIndicator
                                          Definition

                                          Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.

                                          ShortWhether the Medicinal Product is subject to additional monitoring for regulatory reasons
                                          Control1..1
                                          BindingThe codes SHALL be taken from Additional Monitoring Indicator
                                          (required to http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator)
                                          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          118. MedicinalProductDefinition.specialMeasures
                                          Definition

                                          Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorization studies.

                                          ShortWhether the Medicinal Product is subject to special measures for regulatory reasons
                                          Control0..0
                                          BindingFor example codes, see SpecialMeasures
                                          (example to http://hl7.org/fhir/ValueSet/medicinal-product-special-measures)

                                          Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          120. MedicinalProductDefinition.pediatricUseIndicator
                                          Definition

                                          If authorised for use in children, or infants, neonates etc.

                                          ShortIf authorised for use in children
                                          Control1..1
                                          BindingThe codes SHALL be taken from Paediatric Use Indicator
                                          (required to http://ema.europa.eu/fhir/vs/paediatricUseIndicator)
                                          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          122. MedicinalProductDefinition.classification
                                          Definition

                                          Allows the product to be classified by various systems, commonly WHO ATC.

                                          ShortAllows the product to be classified by various systems
                                          Control1..*
                                          BindingFor example codes, see ProductClassification
                                          (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification)

                                          This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          SlicingThis element introduces a set of slices on MedicinalProductDefinition.classification. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                          • value @ coding.system
                                          • 124. MedicinalProductDefinition.classification:xevmpd
                                            Slice Namexevmpd
                                            Definition

                                            Allows the product to be classified by various systems, commonly WHO ATC.

                                            ShortAllows the product to be classified by various systems
                                            Control0..1
                                            BindingFor example codes, see ProductClassification
                                            (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification)

                                            This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.

                                            TypeCodeableConcept(EMA XEVMPD Product CodeableConcept)
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            126. MedicinalProductDefinition.classification:xevmpd.id
                                            Definition

                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                            ShortUnique id for inter-element referencing
                                            Control0..1
                                            This element is affected by the following invariants: ele-1
                                            Typeid
                                            Is Modifierfalse
                                            XML FormatIn the XML format, this property is represented as an attribute.
                                            Summaryfalse
                                            128. MedicinalProductDefinition.classification:xevmpd.extension
                                            Definition

                                            An Extension

                                            ShortExtension
                                            Control0..0
                                            TypeExtension
                                            Is Modifierfalse
                                            Summaryfalse
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                            SlicingThis element introduces a set of slices on MedicinalProductDefinition.classification.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                            • value @ url
                                            • 130. MedicinalProductDefinition.classification:xevmpd.coding
                                              Definition

                                              A reference to a code defined by a terminology system.

                                              ShortCode defined by a terminology system
                                              Comments

                                              Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                              Control0..*
                                              BindingThe codes SHALL be taken from XEVMPD medicinal product type
                                              (required to http://ema.europa.eu/fhir/vs/xevmpdMedicinalProductType)
                                              TypeCoding
                                              Is Modifierfalse
                                              Summarytrue
                                              Requirements

                                              Allows for alternative encodings within a code system, and translations to other code systems.

                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              132. MedicinalProductDefinition.classification:xevmpd.coding.id
                                              Definition

                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                              ShortUnique id for inter-element referencing
                                              Control0..1
                                              This element is affected by the following invariants: ele-1
                                              Typeid
                                              Is Modifierfalse
                                              XML FormatIn the XML format, this property is represented as an attribute.
                                              Summaryfalse
                                              134. MedicinalProductDefinition.classification:xevmpd.coding.extension
                                              Definition

                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                              ShortAdditional content defined by implementations
                                              Comments

                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                              Control0..*
                                              TypeExtension
                                              Is Modifierfalse
                                              Summaryfalse
                                              Alternate Namesextensions, user content
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                              SlicingThis element introduces a set of slices on MedicinalProductDefinition.classification.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                              • value @ url
                                              • 136. MedicinalProductDefinition.classification:xevmpd.coding.system
                                                Definition

                                                The identification of the code system that defines the meaning of the symbol in the code.

                                                ShortIdentity of the terminology system
                                                Comments

                                                The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

                                                Control1..1
                                                Typeuri
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summarytrue
                                                Requirements

                                                Need to be unambiguous about the source of the definition of the symbol.

                                                Pattern Valuehttp://spor.ema.europa.eu/v1/lists/200000000324
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                138. MedicinalProductDefinition.classification:xevmpd.coding.version
                                                Definition

                                                The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                                                ShortVersion of the system - if relevant
                                                Comments

                                                Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                                                NoteThis is a business version Id, not a resource version Id (see discussion)
                                                Control0..1
                                                Typestring
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                140. MedicinalProductDefinition.classification:xevmpd.coding.code
                                                Definition

                                                A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                                                ShortSymbol in syntax defined by the system
                                                Control0..1
                                                This element is affected by the following invariants: cod-1
                                                Typecode
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summarytrue
                                                Requirements

                                                Need to refer to a particular code in the system.

                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                142. MedicinalProductDefinition.classification:xevmpd.coding.display
                                                Definition

                                                A representation of the meaning of the code in the system, following the rules of the system.

                                                ShortRepresentation defined by the system
                                                Control0..1
                                                This element is affected by the following invariants: cod-1
                                                Typestring
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summarytrue
                                                Requirements

                                                Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                144. MedicinalProductDefinition.classification:xevmpd.coding.userSelected
                                                Definition

                                                Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                                                ShortIf this coding was chosen directly by the user
                                                Comments

                                                Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                                                Control0..1
                                                Typeboolean
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summarytrue
                                                Requirements

                                                This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                146. MedicinalProductDefinition.classification:xevmpd.text
                                                Definition

                                                A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                ShortPlain text representation of the concept
                                                Comments

                                                Very often the text is the same as a displayName of one of the codings.

                                                Control0..0
                                                Typestring
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summarytrue
                                                Requirements

                                                The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                148. MedicinalProductDefinition.classification:legalBasis
                                                Slice NamelegalBasis
                                                Definition

                                                Allows the product to be classified by various systems, commonly WHO ATC.

                                                ShortAllows the product to be classified by various systems
                                                Control0..1
                                                BindingFor example codes, see ProductClassification
                                                (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification)

                                                This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.

                                                TypeCodeableConcept(EMA Legal Basis CodeableConcept)
                                                Is Modifierfalse
                                                Must Supportfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                150. MedicinalProductDefinition.classification:legalBasis.id
                                                Definition

                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                ShortUnique id for inter-element referencing
                                                Control0..1
                                                This element is affected by the following invariants: ele-1
                                                Typeid
                                                Is Modifierfalse
                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                Summaryfalse
                                                152. MedicinalProductDefinition.classification:legalBasis.extension
                                                Definition

                                                An Extension

                                                ShortExtension
                                                Control0..0
                                                TypeExtension
                                                Is Modifierfalse
                                                Summaryfalse
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                SlicingThis element introduces a set of slices on MedicinalProductDefinition.classification.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                • value @ url
                                                • 154. MedicinalProductDefinition.classification:legalBasis.coding
                                                  Definition

                                                  A reference to a code defined by a terminology system.

                                                  ShortCode defined by a terminology system
                                                  Comments

                                                  Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                                  Control0..*
                                                  BindingThe codes SHALL be taken from XEVMPD medicinal product type
                                                  (required to http://ema.europa.eu/fhir/vs/marketingAuthorisationApplicationLegalBasis)
                                                  TypeCoding
                                                  Is Modifierfalse
                                                  Summarytrue
                                                  Requirements

                                                  Allows for alternative encodings within a code system, and translations to other code systems.

                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  156. MedicinalProductDefinition.classification:legalBasis.coding.id
                                                  Definition

                                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                  ShortUnique id for inter-element referencing
                                                  Control0..1
                                                  This element is affected by the following invariants: ele-1
                                                  Typeid
                                                  Is Modifierfalse
                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                  Summaryfalse
                                                  158. MedicinalProductDefinition.classification:legalBasis.coding.extension
                                                  Definition

                                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                  ShortAdditional content defined by implementations
                                                  Comments

                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Alternate Namesextensions, user content
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                  SlicingThis element introduces a set of slices on MedicinalProductDefinition.classification.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                  • value @ url
                                                  • 160. MedicinalProductDefinition.classification:legalBasis.coding.system
                                                    Definition

                                                    The identification of the code system that defines the meaning of the symbol in the code.

                                                    ShortIdentity of the terminology system
                                                    Comments

                                                    The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

                                                    Control1..1
                                                    Typeuri
                                                    Is Modifierfalse
                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                    Summarytrue
                                                    Requirements

                                                    Need to be unambiguous about the source of the definition of the symbol.

                                                    Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000116045
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    162. MedicinalProductDefinition.classification:legalBasis.coding.version
                                                    Definition

                                                    The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                                                    ShortVersion of the system - if relevant
                                                    Comments

                                                    Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                                                    NoteThis is a business version Id, not a resource version Id (see discussion)
                                                    Control0..1
                                                    Typestring
                                                    Is Modifierfalse
                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    164. MedicinalProductDefinition.classification:legalBasis.coding.code
                                                    Definition

                                                    A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                                                    ShortSymbol in syntax defined by the system
                                                    Control0..1
                                                    This element is affected by the following invariants: cod-1
                                                    Typecode
                                                    Is Modifierfalse
                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                    Summarytrue
                                                    Requirements

                                                    Need to refer to a particular code in the system.

                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    166. MedicinalProductDefinition.classification:legalBasis.coding.display
                                                    Definition

                                                    A representation of the meaning of the code in the system, following the rules of the system.

                                                    ShortRepresentation defined by the system
                                                    Control0..1
                                                    This element is affected by the following invariants: cod-1
                                                    Typestring
                                                    Is Modifierfalse
                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                    Summarytrue
                                                    Requirements

                                                    Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    168. MedicinalProductDefinition.classification:legalBasis.coding.userSelected
                                                    Definition

                                                    Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                                                    ShortIf this coding was chosen directly by the user
                                                    Comments

                                                    Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                                                    Control0..1
                                                    Typeboolean
                                                    Is Modifierfalse
                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                    Summarytrue
                                                    Requirements

                                                    This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    170. MedicinalProductDefinition.classification:legalBasis.text
                                                    Definition

                                                    A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                    ShortPlain text representation of the concept
                                                    Comments

                                                    Very often the text is the same as a displayName of one of the codings.

                                                    Control0..0
                                                    Typestring
                                                    Is Modifierfalse
                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                    Summarytrue
                                                    Requirements

                                                    The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    172. MedicinalProductDefinition.classification:lightAtc
                                                    Slice NamelightAtc
                                                    Definition

                                                    Allows the product to be classified by various systems, commonly WHO ATC.

                                                    ShortAllows the product to be classified by various systems
                                                    Control1..*
                                                    BindingFor example codes, see ProductClassification
                                                    (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification)

                                                    This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.

                                                    TypeCodeableConcept(EMA Light ATC CodeableConcept)
                                                    Is Modifierfalse
                                                    Must Supportfalse
                                                    Summarytrue
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    174. MedicinalProductDefinition.classification:lightAtc.id
                                                    Definition

                                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                    ShortUnique id for inter-element referencing
                                                    Control0..1
                                                    This element is affected by the following invariants: ele-1
                                                    Typeid
                                                    Is Modifierfalse
                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                    Summaryfalse
                                                    176. MedicinalProductDefinition.classification:lightAtc.extension
                                                    Definition

                                                    The ATC pending Extension

                                                    ShortThe ATC Pending Extension
                                                    Control0..0
                                                    TypeExtension(The ATC Pending Extension) (Extension Type: Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, integer64, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, CodeableReference, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, RatioRange, Reference, SampledData, Signature, Timing, ContactDetail, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Availability, ExtendedContactDetail, Dosage, Meta)
                                                    Is Modifierfalse
                                                    Summaryfalse
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                    183. MedicinalProductDefinition.classification:lightAtc.coding
                                                    Definition

                                                    A reference to a code defined by a terminology system.

                                                    ShortCode defined by a terminology system
                                                    Comments

                                                    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                                    Control1..1
                                                    TypeCoding(EMA ATC Coding)
                                                    Is Modifierfalse
                                                    Summarytrue
                                                    Requirements

                                                    Allows for alternative encodings within a code system, and translations to other code systems.

                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    185. MedicinalProductDefinition.classification:lightAtc.coding.id
                                                    Definition

                                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                    ShortUnique id for inter-element referencing
                                                    Control0..1
                                                    This element is affected by the following invariants: ele-1
                                                    Typeid
                                                    Is Modifierfalse
                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                    Summaryfalse
                                                    187. MedicinalProductDefinition.classification:lightAtc.coding.extension
                                                    Definition

                                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                    ShortAdditional content defined by implementations
                                                    Comments

                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                    Control0..*
                                                    TypeExtension
                                                    Is Modifierfalse
                                                    Summaryfalse
                                                    Alternate Namesextensions, user content
                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                    SlicingThis element introduces a set of slices on MedicinalProductDefinition.classification.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                    • value @ url
                                                    • 189. MedicinalProductDefinition.classification:lightAtc.coding.system
                                                      Definition

                                                      The identification of the code system that defines the meaning of the symbol in the code.

                                                      ShortIdentity of the terminology system
                                                      Comments

                                                      The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

                                                      Control1..1
                                                      Typeuri
                                                      Is Modifierfalse
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Summarytrue
                                                      Requirements

                                                      Need to be unambiguous about the source of the definition of the symbol.

                                                      Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000093533
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      191. MedicinalProductDefinition.classification:lightAtc.coding.system.id
                                                      Definition

                                                      unique id for the element within a resource (for internal references)

                                                      Shortxml:id (or equivalent in JSON)
                                                      Control0..1
                                                      Typestring
                                                      Is Modifierfalse
                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                      Summaryfalse
                                                      193. MedicinalProductDefinition.classification:lightAtc.coding.system.extension
                                                      Definition

                                                      Name of the coding system the 'coding' element belongs to

                                                      ShortCode System Name
                                                      Control0..*
                                                      TypeExtension(Code System Name) (Extension Type: string)
                                                      Is Modifierfalse
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                      195. MedicinalProductDefinition.classification:lightAtc.coding.system.value
                                                      Definition

                                                      The actual value

                                                      ShortPrimitive value for uri
                                                      Control0..1
                                                      Typeuri
                                                      Is Modifierfalse
                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                      Summaryfalse
                                                      197. MedicinalProductDefinition.classification:lightAtc.coding.version
                                                      Definition

                                                      The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                                                      ShortVersion of the system - if relevant
                                                      Comments

                                                      Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                                                      NoteThis is a business version Id, not a resource version Id (see discussion)
                                                      Control0..0
                                                      Typestring
                                                      Is Modifierfalse
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      199. MedicinalProductDefinition.classification:lightAtc.coding.code
                                                      Definition

                                                      A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                                                      ShortSymbol in syntax defined by the system
                                                      Control1..1
                                                      This element is affected by the following invariants: cod-1
                                                      Typecode
                                                      Is Modifierfalse
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Summarytrue
                                                      Requirements

                                                      Need to refer to a particular code in the system.

                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      201. MedicinalProductDefinition.classification:lightAtc.coding.display
                                                      Definition

                                                      A representation of the meaning of the code in the system, following the rules of the system.

                                                      ShortRepresentation defined by the system
                                                      Control0..1
                                                      This element is affected by the following invariants: cod-1
                                                      Typestring
                                                      Is Modifierfalse
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Summarytrue
                                                      Requirements

                                                      Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      203. MedicinalProductDefinition.classification:lightAtc.coding.userSelected
                                                      Definition

                                                      Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                                                      ShortIf this coding was chosen directly by the user
                                                      Comments

                                                      Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                                                      Control0..0
                                                      Typeboolean
                                                      Is Modifierfalse
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Summarytrue
                                                      Requirements

                                                      This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      205. MedicinalProductDefinition.classification:lightAtc.text
                                                      Definition

                                                      A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                      ShortPlain text representation of the concept
                                                      Comments

                                                      Very often the text is the same as a displayName of one of the codings.

                                                      Control0..0
                                                      Typestring
                                                      Is Modifierfalse
                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                      Summarytrue
                                                      Requirements

                                                      The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      207. MedicinalProductDefinition.classification:productCategory
                                                      Slice NameproductCategory
                                                      Definition

                                                      Allows the product to be classified by various systems, commonly WHO ATC.

                                                      ShortAllows the product to be classified by various systems
                                                      Control0..*
                                                      BindingFor example codes, see ProductClassification
                                                      (example to http://hl7.org/fhir/ValueSet/medicinal-product-classification)

                                                      This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.

                                                      TypeCodeableConcept(EMA Product Category CodeableConcept)
                                                      Is Modifierfalse
                                                      Must Supportfalse
                                                      Summarytrue
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      209. MedicinalProductDefinition.classification:productCategory.id
                                                      Definition

                                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                      ShortUnique id for inter-element referencing
                                                      Control0..1
                                                      This element is affected by the following invariants: ele-1
                                                      Typeid
                                                      Is Modifierfalse
                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                      Summaryfalse
                                                      211. MedicinalProductDefinition.classification:productCategory.extension
                                                      Definition

                                                      An Extension

                                                      ShortExtension
                                                      Control0..0
                                                      TypeExtension
                                                      Is Modifierfalse
                                                      Summaryfalse
                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                      SlicingThis element introduces a set of slices on MedicinalProductDefinition.classification.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                      • value @ url
                                                      • 213. MedicinalProductDefinition.classification:productCategory.coding
                                                        Definition

                                                        A reference to a code defined by a terminology system.

                                                        ShortCode defined by a terminology system
                                                        Comments

                                                        Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                                        Control0..*
                                                        BindingThe codes SHALL be taken from Product Category
                                                        (required to http://ema.europa.eu/fhir/vs/productCategory)
                                                        TypeCoding
                                                        Is Modifierfalse
                                                        Summarytrue
                                                        Requirements

                                                        Allows for alternative encodings within a code system, and translations to other code systems.

                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        215. MedicinalProductDefinition.classification:productCategory.coding.id
                                                        Definition

                                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                        ShortUnique id for inter-element referencing
                                                        Control0..1
                                                        This element is affected by the following invariants: ele-1
                                                        Typeid
                                                        Is Modifierfalse
                                                        XML FormatIn the XML format, this property is represented as an attribute.
                                                        Summaryfalse
                                                        217. MedicinalProductDefinition.classification:productCategory.coding.extension
                                                        Definition

                                                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                        ShortAdditional content defined by implementations
                                                        Comments

                                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                        Control0..*
                                                        TypeExtension
                                                        Is Modifierfalse
                                                        Summaryfalse
                                                        Alternate Namesextensions, user content
                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                        SlicingThis element introduces a set of slices on MedicinalProductDefinition.classification.coding.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                        • value @ url
                                                        • 219. MedicinalProductDefinition.classification:productCategory.coding.system
                                                          Definition

                                                          The identification of the code system that defines the meaning of the symbol in the code.

                                                          ShortIdentity of the terminology system
                                                          Comments

                                                          The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.

                                                          Control1..1
                                                          Typeuri
                                                          Is Modifierfalse
                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                          Summarytrue
                                                          Requirements

                                                          Need to be unambiguous about the source of the definition of the symbol.

                                                          Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000155526
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          221. MedicinalProductDefinition.classification:productCategory.coding.version
                                                          Definition

                                                          The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.

                                                          ShortVersion of the system - if relevant
                                                          Comments

                                                          Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.

                                                          NoteThis is a business version Id, not a resource version Id (see discussion)
                                                          Control0..1
                                                          Typestring
                                                          Is Modifierfalse
                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          223. MedicinalProductDefinition.classification:productCategory.coding.code
                                                          Definition

                                                          A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).

                                                          ShortSymbol in syntax defined by the system
                                                          Control0..1
                                                          This element is affected by the following invariants: cod-1
                                                          Typecode
                                                          Is Modifierfalse
                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                          Summarytrue
                                                          Requirements

                                                          Need to refer to a particular code in the system.

                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          225. MedicinalProductDefinition.classification:productCategory.coding.display
                                                          Definition

                                                          A representation of the meaning of the code in the system, following the rules of the system.

                                                          ShortRepresentation defined by the system
                                                          Control0..1
                                                          This element is affected by the following invariants: cod-1
                                                          Typestring
                                                          Is Modifierfalse
                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                          Summarytrue
                                                          Requirements

                                                          Need to be able to carry a human-readable meaning of the code for readers that do not know the system.

                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          227. MedicinalProductDefinition.classification:productCategory.coding.userSelected
                                                          Definition

                                                          Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).

                                                          ShortIf this coding was chosen directly by the user
                                                          Comments

                                                          Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.

                                                          Control0..1
                                                          Typeboolean
                                                          Is Modifierfalse
                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                          Summarytrue
                                                          Requirements

                                                          This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.

                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          229. MedicinalProductDefinition.classification:productCategory.text
                                                          Definition

                                                          A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                          ShortPlain text representation of the concept
                                                          Comments

                                                          Very often the text is the same as a displayName of one of the codings.

                                                          Control0..0
                                                          Typestring
                                                          Is Modifierfalse
                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                          Summarytrue
                                                          Requirements

                                                          The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          231. MedicinalProductDefinition.marketingStatus
                                                          Definition

                                                          Marketing status of the medicinal product, in contrast to marketing authorization. This refers to the product being actually 'on the market' as opposed to being allowed to be on the market (which is an authorization).

                                                          ShortMarketing status of the medicinal product, in contrast to marketing authorization
                                                          Control0..0
                                                          TypeMarketingStatus
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          233. MedicinalProductDefinition.packagedMedicinalProduct
                                                          Definition

                                                          Package type for the product. See also the PackagedProductDefinition resource.

                                                          ShortPackage type for the product
                                                          Control0..0
                                                          BindingFor example codes, see MedicinalProductPackageType
                                                          (example to http://hl7.org/fhir/ValueSet/medicinal-product-package-type)

                                                          Types of medicinal product packs

                                                          TypeCodeableConcept
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          235. MedicinalProductDefinition.comprisedOf
                                                          Definition

                                                          Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes. Used as a direct link when the item's packaging is not being recorded (see also PackagedProductDefinition.package.containedItem.item).

                                                          ShortTypes of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
                                                          Control0..*
                                                          TypeReference(ManufacturedItemDefinition, DeviceDefinition)
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          237. MedicinalProductDefinition.ingredient
                                                          Definition

                                                          The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes.

                                                          ShortThe ingredients of this medicinal product - when not detailed in other resources
                                                          Control0..0
                                                          BindingFor example codes, see SNOMEDCTSubstanceCodes
                                                          (example to http://hl7.org/fhir/ValueSet/substance-codes)

                                                          This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

                                                          TypeCodeableConcept
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          239. MedicinalProductDefinition.impurity
                                                          Definition

                                                          Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products.

                                                          ShortAny component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
                                                          Control0..0
                                                          BindingFor example codes, see SNOMEDCTSubstanceCodes
                                                          (example to http://hl7.org/fhir/ValueSet/substance-codes)

                                                          This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.

                                                          TypeCodeableReference(SubstanceDefinition)
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          241. MedicinalProductDefinition.attachedDocument
                                                          Definition

                                                          Additional information or supporting documentation about the medicinal product.

                                                          ShortAdditional documentation about the medicinal product
                                                          Control0..*
                                                          TypeReference(DocumentReference)
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          243. MedicinalProductDefinition.masterFile
                                                          Definition

                                                          A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products.

                                                          ShortA master file for the medicinal product (e.g. Pharmacovigilance System Master File)
                                                          Control1..1
                                                          TypeReference(DocumentReference)
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          245. MedicinalProductDefinition.contact
                                                          Definition

                                                          A product specific contact, person (in a role), or an organization.

                                                          ShortA product specific contact, person (in a role), or an organization
                                                          Control2..2
                                                          TypeBackboneElement
                                                          Is Modifierfalse
                                                          Must Supportfalse
                                                          Summarytrue
                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                          SlicingThis element introduces a set of slices on MedicinalProductDefinition.contact. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                                          • value @ type.coding.code
                                                          • 247. MedicinalProductDefinition.contact.id
                                                            Definition

                                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                            ShortUnique id for inter-element referencing
                                                            Control0..1
                                                            This element is affected by the following invariants: ele-1
                                                            Typestring
                                                            Is Modifierfalse
                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                            Summaryfalse
                                                            249. MedicinalProductDefinition.contact.extension
                                                            Definition

                                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                            ShortAdditional content defined by implementations
                                                            Comments

                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                            Control0..*
                                                            TypeExtension
                                                            Is Modifierfalse
                                                            Summaryfalse
                                                            Alternate Namesextensions, user content
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                            251. MedicinalProductDefinition.contact.modifierExtension
                                                            Definition

                                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                            ShortExtensions that cannot be ignored even if unrecognized
                                                            Comments

                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                            Control0..*
                                                            TypeExtension
                                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                            Summarytrue
                                                            Requirements

                                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                            Alternate Namesextensions, user content, modifiers
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                            253. MedicinalProductDefinition.contact.type
                                                            Definition

                                                            Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.

                                                            ShortAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
                                                            Control0..1
                                                            BindingFor example codes, see ProductContactType
                                                            (example to http://hl7.org/fhir/ValueSet/medicinal-product-contact-type)

                                                            Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

                                                            TypeCodeableConcept
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            255. MedicinalProductDefinition.contact.contact
                                                            Definition

                                                            A product specific contact, person (in a role), or an organization.

                                                            ShortA product specific contact, person (in a role), or an organization
                                                            Control1..1
                                                            TypeReference(Organization, PractitionerRole)
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            257. MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact
                                                            Slice NamepharmacovigilanceQualifiedPersonContact
                                                            Definition

                                                            A product specific contact, person (in a role), or an organization.

                                                            ShortA product specific contact, person (in a role), or an organization
                                                            Control1..1
                                                            TypeBackboneElement
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            259. MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact.id
                                                            Definition

                                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                            ShortUnique id for inter-element referencing
                                                            Control0..1
                                                            This element is affected by the following invariants: ele-1
                                                            Typestring
                                                            Is Modifierfalse
                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                            Summaryfalse
                                                            261. MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact.extension
                                                            Definition

                                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                            ShortAdditional content defined by implementations
                                                            Comments

                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                            Control0..*
                                                            TypeExtension
                                                            Is Modifierfalse
                                                            Summaryfalse
                                                            Alternate Namesextensions, user content
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                            263. MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact.modifierExtension
                                                            Definition

                                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                            ShortExtensions that cannot be ignored even if unrecognized
                                                            Comments

                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                            Control0..*
                                                            TypeExtension
                                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                            Summarytrue
                                                            Requirements

                                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                            Alternate Namesextensions, user content, modifiers
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                            265. MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact.type
                                                            Definition

                                                            Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.

                                                            ShortAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
                                                            Control0..1
                                                            BindingFor example codes, see ProductContactType
                                                            (example to http://hl7.org/fhir/ValueSet/medicinal-product-contact-type)

                                                            Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

                                                            TypeCodeableConcept(EMA Pharmacovigilance Qualified Person Type CodeableConcept)
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            267. MedicinalProductDefinition.contact:pharmacovigilanceQualifiedPersonContact.contact
                                                            Definition

                                                            A product specific contact, person (in a role), or an organization.

                                                            ShortA product specific contact, person (in a role), or an organization
                                                            Control1..1
                                                            TypeReference(PractitionerRole)
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            269. MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact
                                                            Slice NamepharmacovigilanceEnquiryContact
                                                            Definition

                                                            A product specific contact, person (in a role), or an organization.

                                                            ShortA product specific contact, person (in a role), or an organization
                                                            Control1..1
                                                            TypeBackboneElement
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            271. MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact.id
                                                            Definition

                                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                            ShortUnique id for inter-element referencing
                                                            Control0..1
                                                            This element is affected by the following invariants: ele-1
                                                            Typestring
                                                            Is Modifierfalse
                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                            Summaryfalse
                                                            273. MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact.extension
                                                            Definition

                                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                            ShortAdditional content defined by implementations
                                                            Comments

                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                            Control0..*
                                                            TypeExtension
                                                            Is Modifierfalse
                                                            Summaryfalse
                                                            Alternate Namesextensions, user content
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                            275. MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact.modifierExtension
                                                            Definition

                                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                            ShortExtensions that cannot be ignored even if unrecognized
                                                            Comments

                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                            Control0..*
                                                            TypeExtension
                                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                            Summarytrue
                                                            Requirements

                                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                            Alternate Namesextensions, user content, modifiers
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                            277. MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact.type
                                                            Definition

                                                            Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.

                                                            ShortAllows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
                                                            Control0..1
                                                            BindingFor example codes, see ProductContactType
                                                            (example to http://hl7.org/fhir/ValueSet/medicinal-product-contact-type)

                                                            Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

                                                            TypeCodeableConcept(EMA Pharmacovigilance Qualified Person Type CodeableConcept)
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            279. MedicinalProductDefinition.contact:pharmacovigilanceEnquiryContact.contact
                                                            Definition

                                                            A product specific contact, person (in a role), or an organization.

                                                            ShortA product specific contact, person (in a role), or an organization
                                                            Control1..1
                                                            TypeReference(Organization)
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            281. MedicinalProductDefinition.clinicalTrial
                                                            Definition

                                                            Clinical trials or studies that this product is involved in.

                                                            ShortClinical trials or studies that this product is involved in
                                                            Control0..*
                                                            TypeReference(ResearchStudy)
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            283. MedicinalProductDefinition.code
                                                            Definition

                                                            A code that this product is known by, usually within some formal terminology, perhaps assigned by a third party (i.e. not the manufacturer or regulator). Products (types of medications) tend to be known by identifiers during development and within regulatory process. However when they are prescribed they tend to be identified by codes. The same product may be have multiple codes, applied to it by multiple organizations.

                                                            ShortA code that this product is known by, within some formal terminology
                                                            Control0..0
                                                            BindingFor example codes, see SNOMEDCTMedicationCodes
                                                            (example to http://hl7.org/fhir/ValueSet/medication-codes)

                                                            A coded concept that defines the type of a medication.

                                                            TypeCoding
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            285. MedicinalProductDefinition.name
                                                            Definition

                                                            The product's name, including full name and possibly coded parts.

                                                            ShortThe product's name, including full name and possibly coded parts
                                                            Control1..1
                                                            TypeBackboneElement
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            287. MedicinalProductDefinition.name.id
                                                            Definition

                                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                            ShortUnique id for inter-element referencing
                                                            Control0..1
                                                            This element is affected by the following invariants: ele-1
                                                            Typestring
                                                            Is Modifierfalse
                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                            Summaryfalse
                                                            289. MedicinalProductDefinition.name.extension
                                                            Definition

                                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                            ShortAdditional content defined by implementations
                                                            Comments

                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                            Control0..*
                                                            TypeExtension
                                                            Is Modifierfalse
                                                            Summaryfalse
                                                            Alternate Namesextensions, user content
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                            291. MedicinalProductDefinition.name.modifierExtension
                                                            Definition

                                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                            ShortExtensions that cannot be ignored even if unrecognized
                                                            Comments

                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                            Control0..*
                                                            TypeExtension
                                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                            Summarytrue
                                                            Requirements

                                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                            Alternate Namesextensions, user content, modifiers
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                            293. MedicinalProductDefinition.name.productName
                                                            Definition

                                                            The full product name.

                                                            ShortThe full product name
                                                            Control1..1
                                                            Typestring
                                                            Is Modifierfalse
                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            295. MedicinalProductDefinition.name.type
                                                            Definition

                                                            Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.

                                                            ShortType of product name, such as rINN, BAN, Proprietary, Non-Proprietary
                                                            Control0..1
                                                            BindingThe codes SHALL be taken from Medicinal Product Name Part Type
                                                            (required to http://ema.europa.eu/fhir/vs/productNamePartType)
                                                            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            297. MedicinalProductDefinition.name.part
                                                            Definition

                                                            Coding words or phrases of the name.

                                                            ShortCoding words or phrases of the name
                                                            Control1..*
                                                            TypeBackboneElement
                                                            Is Modifierfalse
                                                            Must Supportfalse
                                                            Summarytrue
                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                            SlicingThis element introduces a set of slices on MedicinalProductDefinition.name.part. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                            • value @ type
                                                            • 299. MedicinalProductDefinition.name.part.id
                                                              Definition

                                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                              ShortUnique id for inter-element referencing
                                                              Control0..1
                                                              This element is affected by the following invariants: ele-1
                                                              Typestring
                                                              Is Modifierfalse
                                                              XML FormatIn the XML format, this property is represented as an attribute.
                                                              Summaryfalse
                                                              301. MedicinalProductDefinition.name.part.extension
                                                              Definition

                                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                              ShortAdditional content defined by implementations
                                                              Comments

                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                              Control0..*
                                                              TypeExtension
                                                              Is Modifierfalse
                                                              Summaryfalse
                                                              Alternate Namesextensions, user content
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                              303. MedicinalProductDefinition.name.part.modifierExtension
                                                              Definition

                                                              May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                              Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                              ShortExtensions that cannot be ignored even if unrecognized
                                                              Comments

                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                              Control0..*
                                                              TypeExtension
                                                              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                              Summarytrue
                                                              Requirements

                                                              Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                              Alternate Namesextensions, user content, modifiers
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                              305. MedicinalProductDefinition.name.part.part
                                                              Definition

                                                              A fragment of a product name.

                                                              ShortA fragment of a product name
                                                              Control1..1
                                                              Typestring
                                                              Is Modifierfalse
                                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                              Must Supportfalse
                                                              Summarytrue
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              307. MedicinalProductDefinition.name.part.type
                                                              Definition

                                                              Identifying type for this part of the name (e.g. strength part).

                                                              ShortIdentifying type for this part of the name (e.g. strength part)
                                                              Control1..1
                                                              BindingFor example codes, see ProductNamePartType
                                                              (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                                                              Type of part of a name for a Medicinal Product.

                                                              TypeCodeableConcept
                                                              Is Modifierfalse
                                                              Must Supportfalse
                                                              Summarytrue
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              309. MedicinalProductDefinition.name.part.type.id
                                                              Definition

                                                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                              ShortUnique id for inter-element referencing
                                                              Control0..1
                                                              This element is affected by the following invariants: ele-1
                                                              Typeid
                                                              Is Modifierfalse
                                                              XML FormatIn the XML format, this property is represented as an attribute.
                                                              Summaryfalse
                                                              311. MedicinalProductDefinition.name.part.type.extension
                                                              Definition

                                                              May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                              ShortAdditional content defined by implementations
                                                              Comments

                                                              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                              Control0..*
                                                              TypeExtension
                                                              Is Modifierfalse
                                                              Summaryfalse
                                                              Alternate Namesextensions, user content
                                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                              SlicingThis element introduces a set of slices on MedicinalProductDefinition.name.part.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                              • value @ url
                                                              • 313. MedicinalProductDefinition.name.part.type.coding
                                                                Definition

                                                                A reference to a code defined by a terminology system.

                                                                ShortCode defined by a terminology system
                                                                Comments

                                                                Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                                                Control0..*
                                                                BindingThe codes SHALL be taken from Medicinal Product Name Part Type
                                                                (required to http://ema.europa.eu/fhir/vs/productNamePartType)
                                                                TypeCoding(The MPD Name Part Type Coding)
                                                                Is Modifierfalse
                                                                Summarytrue
                                                                Requirements

                                                                Allows for alternative encodings within a code system, and translations to other code systems.

                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                315. MedicinalProductDefinition.name.part.type.text
                                                                Definition

                                                                A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                                ShortPlain text representation of the concept
                                                                Comments

                                                                Very often the text is the same as a displayName of one of the codings.

                                                                Control0..1
                                                                Typestring
                                                                Is Modifierfalse
                                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                Summarytrue
                                                                Requirements

                                                                The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                317. MedicinalProductDefinition.name.part:inventedName
                                                                Slice NameinventedName
                                                                Definition

                                                                Coding words or phrases of the name.

                                                                ShortCoding words or phrases of the name
                                                                Control0..1
                                                                TypeBackboneElement
                                                                Is Modifierfalse
                                                                Must Supportfalse
                                                                Summarytrue
                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                319. MedicinalProductDefinition.name.part:inventedName.id
                                                                Definition

                                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                ShortUnique id for inter-element referencing
                                                                Control0..1
                                                                This element is affected by the following invariants: ele-1
                                                                Typestring
                                                                Is Modifierfalse
                                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                                Summaryfalse
                                                                321. MedicinalProductDefinition.name.part:inventedName.extension
                                                                Definition

                                                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                ShortAdditional content defined by implementations
                                                                Comments

                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                Control0..*
                                                                TypeExtension
                                                                Is Modifierfalse
                                                                Summaryfalse
                                                                Alternate Namesextensions, user content
                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                323. MedicinalProductDefinition.name.part:inventedName.modifierExtension
                                                                Definition

                                                                May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                ShortExtensions that cannot be ignored even if unrecognized
                                                                Comments

                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                Control0..*
                                                                TypeExtension
                                                                Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                Summarytrue
                                                                Requirements

                                                                Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                Alternate Namesextensions, user content, modifiers
                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                325. MedicinalProductDefinition.name.part:inventedName.part
                                                                Definition

                                                                A fragment of a product name.

                                                                ShortA fragment of a product name
                                                                Control1..1
                                                                Typestring
                                                                Is Modifierfalse
                                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                Must Supportfalse
                                                                Summarytrue
                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                327. MedicinalProductDefinition.name.part:inventedName.type
                                                                Definition

                                                                Identifying type for this part of the name (e.g. strength part).

                                                                ShortIdentifying type for this part of the name (e.g. strength part)
                                                                Control1..1
                                                                BindingFor example codes, see ProductNamePartType
                                                                (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                                                                Type of part of a name for a Medicinal Product.

                                                                TypeCodeableConcept
                                                                Is Modifierfalse
                                                                Must Supportfalse
                                                                Summarytrue
                                                                Pattern Value{
                                                                  "coding" : [{
                                                                    "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                                                                    "code" : "220000000002"
                                                                  }]
                                                                }
                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                329. MedicinalProductDefinition.name.part:inventedName.type.id
                                                                Definition

                                                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                ShortUnique id for inter-element referencing
                                                                Control0..1
                                                                This element is affected by the following invariants: ele-1
                                                                Typeid
                                                                Is Modifierfalse
                                                                XML FormatIn the XML format, this property is represented as an attribute.
                                                                Summaryfalse
                                                                331. MedicinalProductDefinition.name.part:inventedName.type.extension
                                                                Definition

                                                                May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                ShortAdditional content defined by implementations
                                                                Comments

                                                                There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                Control0..*
                                                                TypeExtension
                                                                Is Modifierfalse
                                                                Summaryfalse
                                                                Alternate Namesextensions, user content
                                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                SlicingThis element introduces a set of slices on MedicinalProductDefinition.name.part.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                • value @ url
                                                                • 333. MedicinalProductDefinition.name.part:inventedName.type.coding
                                                                  Definition

                                                                  A reference to a code defined by a terminology system.

                                                                  ShortCode defined by a terminology system
                                                                  Comments

                                                                  Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                                                  Control0..*
                                                                  BindingThe codes SHALL be taken from Medicinal Product Name Part Type
                                                                  (required to http://ema.europa.eu/fhir/vs/productNamePartType)
                                                                  TypeCoding(The MPD Name Part Type Coding)
                                                                  Is Modifierfalse
                                                                  Summarytrue
                                                                  Requirements

                                                                  Allows for alternative encodings within a code system, and translations to other code systems.

                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  335. MedicinalProductDefinition.name.part:inventedName.type.text
                                                                  Definition

                                                                  A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                                  ShortPlain text representation of the concept
                                                                  Comments

                                                                  Very often the text is the same as a displayName of one of the codings.

                                                                  Control0..1
                                                                  Typestring
                                                                  Is Modifierfalse
                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                  Summarytrue
                                                                  Requirements

                                                                  The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  337. MedicinalProductDefinition.name.part:fullName
                                                                  Slice NamefullName
                                                                  Definition

                                                                  Coding words or phrases of the name.

                                                                  ShortCoding words or phrases of the name
                                                                  Control0..1
                                                                  TypeBackboneElement
                                                                  Is Modifierfalse
                                                                  Must Supportfalse
                                                                  Summarytrue
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  339. MedicinalProductDefinition.name.part:fullName.id
                                                                  Definition

                                                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                  ShortUnique id for inter-element referencing
                                                                  Control0..1
                                                                  This element is affected by the following invariants: ele-1
                                                                  Typestring
                                                                  Is Modifierfalse
                                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                                  Summaryfalse
                                                                  341. MedicinalProductDefinition.name.part:fullName.extension
                                                                  Definition

                                                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                  ShortAdditional content defined by implementations
                                                                  Comments

                                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                  Control0..*
                                                                  TypeExtension
                                                                  Is Modifierfalse
                                                                  Summaryfalse
                                                                  Alternate Namesextensions, user content
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                  343. MedicinalProductDefinition.name.part:fullName.modifierExtension
                                                                  Definition

                                                                  May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                  Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                  ShortExtensions that cannot be ignored even if unrecognized
                                                                  Comments

                                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                  Control0..*
                                                                  TypeExtension
                                                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                  Summarytrue
                                                                  Requirements

                                                                  Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                  Alternate Namesextensions, user content, modifiers
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                  345. MedicinalProductDefinition.name.part:fullName.part
                                                                  Definition

                                                                  A fragment of a product name.

                                                                  ShortA fragment of a product name
                                                                  Control1..1
                                                                  Typestring
                                                                  Is Modifierfalse
                                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                  Must Supportfalse
                                                                  Summarytrue
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  347. MedicinalProductDefinition.name.part:fullName.type
                                                                  Definition

                                                                  Identifying type for this part of the name (e.g. strength part).

                                                                  ShortIdentifying type for this part of the name (e.g. strength part)
                                                                  Control1..1
                                                                  BindingFor example codes, see ProductNamePartType
                                                                  (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                                                                  Type of part of a name for a Medicinal Product.

                                                                  TypeCodeableConcept
                                                                  Is Modifierfalse
                                                                  Must Supportfalse
                                                                  Summarytrue
                                                                  Pattern Value{
                                                                    "coding" : [{
                                                                      "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                                                                      "code" : "220000000001"
                                                                    }]
                                                                  }
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  349. MedicinalProductDefinition.name.part:fullName.type.id
                                                                  Definition

                                                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                  ShortUnique id for inter-element referencing
                                                                  Control0..1
                                                                  This element is affected by the following invariants: ele-1
                                                                  Typeid
                                                                  Is Modifierfalse
                                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                                  Summaryfalse
                                                                  351. MedicinalProductDefinition.name.part:fullName.type.extension
                                                                  Definition

                                                                  May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                  ShortAdditional content defined by implementations
                                                                  Comments

                                                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                  Control0..*
                                                                  TypeExtension
                                                                  Is Modifierfalse
                                                                  Summaryfalse
                                                                  Alternate Namesextensions, user content
                                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                  SlicingThis element introduces a set of slices on MedicinalProductDefinition.name.part.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                  • value @ url
                                                                  • 353. MedicinalProductDefinition.name.part:fullName.type.coding
                                                                    Definition

                                                                    A reference to a code defined by a terminology system.

                                                                    ShortCode defined by a terminology system
                                                                    Comments

                                                                    Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                                                    Control0..*
                                                                    BindingThe codes SHALL be taken from Medicinal Product Name Part Type
                                                                    (required to http://ema.europa.eu/fhir/vs/productNamePartType)
                                                                    TypeCoding(The MPD Name Part Type Coding)
                                                                    Is Modifierfalse
                                                                    Summarytrue
                                                                    Requirements

                                                                    Allows for alternative encodings within a code system, and translations to other code systems.

                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    355. MedicinalProductDefinition.name.part:fullName.type.text
                                                                    Definition

                                                                    A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                                    ShortPlain text representation of the concept
                                                                    Comments

                                                                    Very often the text is the same as a displayName of one of the codings.

                                                                    Control0..1
                                                                    Typestring
                                                                    Is Modifierfalse
                                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                    Summarytrue
                                                                    Requirements

                                                                    The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    357. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm
                                                                    Slice NamepharmaceuticalDoseForm
                                                                    Definition

                                                                    Coding words or phrases of the name.

                                                                    ShortCoding words or phrases of the name
                                                                    Control0..1
                                                                    TypeBackboneElement
                                                                    Is Modifierfalse
                                                                    Must Supportfalse
                                                                    Summarytrue
                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    359. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.id
                                                                    Definition

                                                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                    ShortUnique id for inter-element referencing
                                                                    Control0..1
                                                                    This element is affected by the following invariants: ele-1
                                                                    Typestring
                                                                    Is Modifierfalse
                                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                                    Summaryfalse
                                                                    361. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.extension
                                                                    Definition

                                                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                    ShortAdditional content defined by implementations
                                                                    Comments

                                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                    Control0..*
                                                                    TypeExtension
                                                                    Is Modifierfalse
                                                                    Summaryfalse
                                                                    Alternate Namesextensions, user content
                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                    363. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.modifierExtension
                                                                    Definition

                                                                    May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                    Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                    ShortExtensions that cannot be ignored even if unrecognized
                                                                    Comments

                                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                    Control0..*
                                                                    TypeExtension
                                                                    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                    Summarytrue
                                                                    Requirements

                                                                    Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                    Alternate Namesextensions, user content, modifiers
                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                    365. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.part
                                                                    Definition

                                                                    A fragment of a product name.

                                                                    ShortA fragment of a product name
                                                                    Control1..1
                                                                    Typestring
                                                                    Is Modifierfalse
                                                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                    Must Supportfalse
                                                                    Summarytrue
                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    367. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type
                                                                    Definition

                                                                    Identifying type for this part of the name (e.g. strength part).

                                                                    ShortIdentifying type for this part of the name (e.g. strength part)
                                                                    Control1..1
                                                                    BindingFor example codes, see ProductNamePartType
                                                                    (example to http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type)

                                                                    Type of part of a name for a Medicinal Product.

                                                                    TypeCodeableConcept
                                                                    Is Modifierfalse
                                                                    Must Supportfalse
                                                                    Summarytrue
                                                                    Pattern Value{
                                                                      "coding" : [{
                                                                        "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                                                                        "code" : "220000000005"
                                                                      }]
                                                                    }
                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    369. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type.id
                                                                    Definition

                                                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                    ShortUnique id for inter-element referencing
                                                                    Control0..1
                                                                    This element is affected by the following invariants: ele-1
                                                                    Typeid
                                                                    Is Modifierfalse
                                                                    XML FormatIn the XML format, this property is represented as an attribute.
                                                                    Summaryfalse
                                                                    371. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type.extension
                                                                    Definition

                                                                    May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                    ShortAdditional content defined by implementations
                                                                    Comments

                                                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                    Control0..*
                                                                    TypeExtension
                                                                    Is Modifierfalse
                                                                    Summaryfalse
                                                                    Alternate Namesextensions, user content
                                                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                    SlicingThis element introduces a set of slices on MedicinalProductDefinition.name.part.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                    • value @ url
                                                                    • 373. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type.coding
                                                                      Definition

                                                                      A reference to a code defined by a terminology system.

                                                                      ShortCode defined by a terminology system
                                                                      Comments

                                                                      Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                                                      Control0..*
                                                                      BindingThe codes SHALL be taken from Medicinal Product Name Part Type
                                                                      (required to http://ema.europa.eu/fhir/vs/productNamePartType)
                                                                      TypeCoding(The MPD Name Part Type Coding)
                                                                      Is Modifierfalse
                                                                      Summarytrue
                                                                      Requirements

                                                                      Allows for alternative encodings within a code system, and translations to other code systems.

                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      375. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type.text
                                                                      Definition

                                                                      A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                                                      ShortPlain text representation of the concept
                                                                      Comments

                                                                      Very often the text is the same as a displayName of one of the codings.

                                                                      Control0..1
                                                                      Typestring
                                                                      Is Modifierfalse
                                                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                      Summarytrue
                                                                      Requirements

                                                                      The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      377. MedicinalProductDefinition.name.usage
                                                                      Definition

                                                                      Country and jurisdiction where the name applies, and associated language.

                                                                      ShortCountry and jurisdiction where the name applies
                                                                      Control1..1
                                                                      TypeBackboneElement
                                                                      Is Modifierfalse
                                                                      Must Supportfalse
                                                                      Summarytrue
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      379. MedicinalProductDefinition.name.usage.id
                                                                      Definition

                                                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                      ShortUnique id for inter-element referencing
                                                                      Control0..1
                                                                      This element is affected by the following invariants: ele-1
                                                                      Typestring
                                                                      Is Modifierfalse
                                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                                      Summaryfalse
                                                                      381. MedicinalProductDefinition.name.usage.extension
                                                                      Definition

                                                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                      ShortAdditional content defined by implementations
                                                                      Comments

                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                      Control0..*
                                                                      TypeExtension
                                                                      Is Modifierfalse
                                                                      Summaryfalse
                                                                      Alternate Namesextensions, user content
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                      383. MedicinalProductDefinition.name.usage.modifierExtension
                                                                      Definition

                                                                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                      ShortExtensions that cannot be ignored even if unrecognized
                                                                      Comments

                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                      Control0..*
                                                                      TypeExtension
                                                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                      Summarytrue
                                                                      Requirements

                                                                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                      Alternate Namesextensions, user content, modifiers
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                      385. MedicinalProductDefinition.name.usage.country
                                                                      Definition

                                                                      Country code for where this name applies.

                                                                      ShortCountry code for where this name applies
                                                                      Control1..1
                                                                      BindingThe codes SHALL be taken from Country
                                                                      (required to http://ema.europa.eu/fhir/vs/country)
                                                                      TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                                                      Is Modifierfalse
                                                                      Must Supportfalse
                                                                      Summarytrue
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      387. MedicinalProductDefinition.name.usage.jurisdiction
                                                                      Definition

                                                                      Jurisdiction code for where this name applies. A jurisdiction may be a sub- or supra-national entity (e.g. a state or a geographic region).

                                                                      ShortJurisdiction code for where this name applies
                                                                      Control0..1
                                                                      BindingFor example codes, see JurisdictionValueSet
                                                                      (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                                                      Jurisdiction codes

                                                                      TypeCodeableConcept
                                                                      Is Modifierfalse
                                                                      Must Supportfalse
                                                                      Summarytrue
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      389. MedicinalProductDefinition.name.usage.language
                                                                      Definition

                                                                      Language code for this name.

                                                                      ShortLanguage code for this name
                                                                      Control1..1
                                                                      BindingThe codes SHALL be taken from Language
                                                                      (required to http://ema.europa.eu/fhir/vs/language)
                                                                      TypeCodeableConcept
                                                                      Is Modifierfalse
                                                                      Must Supportfalse
                                                                      Summarytrue
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      391. MedicinalProductDefinition.crossReference
                                                                      Definition

                                                                      Reference to another product, e.g. for linking authorised to investigational product, or a virtual product.

                                                                      ShortReference to another product, e.g. for linking authorised to investigational product
                                                                      Control0..1
                                                                      TypeBackboneElement
                                                                      Is Modifierfalse
                                                                      Must Supportfalse
                                                                      Summarytrue
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      393. MedicinalProductDefinition.crossReference.id
                                                                      Definition

                                                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                      ShortUnique id for inter-element referencing
                                                                      Control0..1
                                                                      This element is affected by the following invariants: ele-1
                                                                      Typestring
                                                                      Is Modifierfalse
                                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                                      Summaryfalse
                                                                      395. MedicinalProductDefinition.crossReference.extension
                                                                      Definition

                                                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                      ShortAdditional content defined by implementations
                                                                      Comments

                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                      Control0..*
                                                                      TypeExtension
                                                                      Is Modifierfalse
                                                                      Summaryfalse
                                                                      Alternate Namesextensions, user content
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                      397. MedicinalProductDefinition.crossReference.modifierExtension
                                                                      Definition

                                                                      May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                      Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                      ShortExtensions that cannot be ignored even if unrecognized
                                                                      Comments

                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                      Control0..*
                                                                      TypeExtension
                                                                      Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                      Summarytrue
                                                                      Requirements

                                                                      Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                      Alternate Namesextensions, user content, modifiers
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                      399. MedicinalProductDefinition.crossReference.product
                                                                      Definition

                                                                      Reference to another product, e.g. for linking authorised to investigational product.

                                                                      ShortReference to another product, e.g. for linking authorised to investigational product
                                                                      Control1..1
                                                                      TypeCodeableReference(MedicinalProductDefinition)
                                                                      Is Modifierfalse
                                                                      Must Supportfalse
                                                                      Summarytrue
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      401. MedicinalProductDefinition.crossReference.product.id
                                                                      Definition

                                                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                      ShortUnique id for inter-element referencing
                                                                      Control0..1
                                                                      This element is affected by the following invariants: ele-1
                                                                      Typeid
                                                                      Is Modifierfalse
                                                                      XML FormatIn the XML format, this property is represented as an attribute.
                                                                      Summaryfalse
                                                                      403. MedicinalProductDefinition.crossReference.product.extension
                                                                      Definition

                                                                      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                      ShortAdditional content defined by implementations
                                                                      Comments

                                                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                      Control0..*
                                                                      TypeExtension
                                                                      Is Modifierfalse
                                                                      Summaryfalse
                                                                      Alternate Namesextensions, user content
                                                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                      SlicingThis element introduces a set of slices on MedicinalProductDefinition.crossReference.product.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                      • value @ url
                                                                      • 405. MedicinalProductDefinition.crossReference.product.concept
                                                                        Definition

                                                                        A reference to a concept - e.g. the information is identified by its general class to the degree of precision found in the terminology.

                                                                        ShortReference to a concept (by class)
                                                                        Control0..1
                                                                        TypeCodeableConcept
                                                                        Is Modifierfalse
                                                                        Summarytrue
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        407. MedicinalProductDefinition.crossReference.product.reference
                                                                        Definition

                                                                        A reference to a resource the provides exact details about the information being referenced.

                                                                        ShortReference to a resource (by instance)
                                                                        Control0..1
                                                                        TypeReference
                                                                        Is Modifierfalse
                                                                        Summarytrue
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        409. MedicinalProductDefinition.crossReference.product.reference.id
                                                                        Definition

                                                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                        ShortUnique id for inter-element referencing
                                                                        Control0..1
                                                                        This element is affected by the following invariants: ele-1
                                                                        Typeid
                                                                        Is Modifierfalse
                                                                        XML FormatIn the XML format, this property is represented as an attribute.
                                                                        Summaryfalse
                                                                        411. MedicinalProductDefinition.crossReference.product.reference.extension
                                                                        Definition

                                                                        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                        ShortAdditional content defined by implementations
                                                                        Comments

                                                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                        Control0..*
                                                                        TypeExtension
                                                                        Is Modifierfalse
                                                                        Summaryfalse
                                                                        Alternate Namesextensions, user content
                                                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                        SlicingThis element introduces a set of slices on MedicinalProductDefinition.crossReference.product.reference.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                        • value @ url
                                                                        • 413. MedicinalProductDefinition.crossReference.product.reference.reference
                                                                          Definition

                                                                          A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

                                                                          ShortLiteral reference, Relative, internal or absolute URL
                                                                          Comments

                                                                          Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

                                                                          Control0..1
                                                                          This element is affected by the following invariants: ref-2, ref-1
                                                                          Typestring
                                                                          Is Modifierfalse
                                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                          Summarytrue
                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                          415. MedicinalProductDefinition.crossReference.product.reference.type
                                                                          Definition

                                                                          The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

                                                                          The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

                                                                          ShortType the reference refers to (e.g. "Patient") - must be a resource in resources
                                                                          Comments

                                                                          This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.

                                                                          Control0..1
                                                                          BindingUnless not suitable, these codes SHALL be taken from ResourceType
                                                                          (extensible to http://hl7.org/fhir/ValueSet/resource-types)

                                                                          Aa resource (or, for logical models, the URI of the logical model).

                                                                          Typeuri
                                                                          Is Modifierfalse
                                                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                          Summarytrue
                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                          417. MedicinalProductDefinition.crossReference.product.reference.identifier
                                                                          Definition

                                                                          An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

                                                                          ShortLogical reference, when literal reference is not known
                                                                          Comments

                                                                          When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

                                                                          When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

                                                                          Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

                                                                          Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

                                                                          This element only allows for a single identifier. In the case where additional identifers are required, use the http://hl7.org/fhir/StructureDefinition/additionalIdentifier extension.

                                                                          NoteThis is a business identifier, not a resource identifier (see discussion)
                                                                          Control1..1
                                                                          This element is affected by the following invariants: ref-2
                                                                          TypeIdentifier
                                                                          Is Modifierfalse
                                                                          Summarytrue
                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                          419. MedicinalProductDefinition.crossReference.product.reference.identifier.id
                                                                          Definition

                                                                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                          ShortUnique id for inter-element referencing
                                                                          Control0..1
                                                                          This element is affected by the following invariants: ele-1
                                                                          Typeid
                                                                          Is Modifierfalse
                                                                          XML FormatIn the XML format, this property is represented as an attribute.
                                                                          Summaryfalse
                                                                          421. MedicinalProductDefinition.crossReference.product.reference.identifier.extension
                                                                          Definition

                                                                          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                          ShortAdditional content defined by implementations
                                                                          Comments

                                                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                          Control0..*
                                                                          TypeExtension
                                                                          Is Modifierfalse
                                                                          Summaryfalse
                                                                          Alternate Namesextensions, user content
                                                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                          SlicingThis element introduces a set of slices on MedicinalProductDefinition.crossReference.product.reference.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                                                          • value @ url
                                                                          • 423. MedicinalProductDefinition.crossReference.product.reference.identifier.use
                                                                            Definition

                                                                            The purpose of this identifier.

                                                                            Shortusual | official | temp | secondary | old (If known)
                                                                            Comments

                                                                            Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                                                                            Control0..1
                                                                            BindingThe codes SHALL be taken from IdentifierUse
                                                                            (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

                                                                            Identifies the purpose for this identifier, if known .

                                                                            Typecode
                                                                            Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                            Summarytrue
                                                                            Requirements

                                                                            Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            425. MedicinalProductDefinition.crossReference.product.reference.identifier.type
                                                                            Definition

                                                                            A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                                                                            ShortDescription of identifier
                                                                            Comments

                                                                            This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.

                                                                            Control0..1
                                                                            BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
                                                                            (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

                                                                            A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                                                                            TypeCodeableConcept
                                                                            Is Modifierfalse
                                                                            Summarytrue
                                                                            Requirements

                                                                            Allows users to make use of identifiers when the identifier system is not known.

                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            427. MedicinalProductDefinition.crossReference.product.reference.identifier.system
                                                                            Definition

                                                                            Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

                                                                            ShortThe namespace for the identifier value
                                                                            Comments

                                                                            Identifier.system is always case sensitive.

                                                                            Control0..1
                                                                            Typeuri
                                                                            Is Modifierfalse
                                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                            Summarytrue
                                                                            Requirements

                                                                            There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.

                                                                            Pattern Valuehttp://ema.europa.eu/fhir/crossReference
                                                                            Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            429. MedicinalProductDefinition.crossReference.product.reference.identifier.value
                                                                            Definition

                                                                            The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                                                                            ShortThe value that is unique
                                                                            Comments

                                                                            If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the http://hl7.org/fhir/StructureDefinition/rendered-value). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.

                                                                            Control0..1
                                                                            This element is affected by the following invariants: ident-1
                                                                            Typestring
                                                                            Is Modifierfalse
                                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                            Summarytrue
                                                                            Example<br/><b>General</b>:123456
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            431. MedicinalProductDefinition.crossReference.product.reference.identifier.period
                                                                            Definition

                                                                            Time period during which identifier is/was valid for use.

                                                                            ShortTime period when id is/was valid for use
                                                                            Control0..1
                                                                            TypePeriod
                                                                            Is Modifierfalse
                                                                            Summarytrue
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            433. MedicinalProductDefinition.crossReference.product.reference.identifier.assigner
                                                                            Definition

                                                                            Organization that issued/manages the identifier.

                                                                            ShortOrganization that issued id (may be just text)
                                                                            Comments

                                                                            The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.

                                                                            Control0..1
                                                                            TypeReference(Organization)
                                                                            Is Modifierfalse
                                                                            Summarytrue
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            435. MedicinalProductDefinition.crossReference.product.reference.display
                                                                            Definition

                                                                            Plain text narrative that identifies the resource in addition to the resource reference.

                                                                            ShortText alternative for the resource
                                                                            Comments

                                                                            This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

                                                                            Control0..1
                                                                            This element is affected by the following invariants: ref-2
                                                                            Typestring
                                                                            Is Modifierfalse
                                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                            Summarytrue
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            437. MedicinalProductDefinition.crossReference.type
                                                                            Definition

                                                                            The type of relationship, for instance branded to generic, virtual to actual product, product to development product (investigational), parallel import version.

                                                                            ShortThe type of relationship, for instance branded to generic or virtual to actual product
                                                                            Control1..1
                                                                            BindingThe codes SHALL be taken from Product Cross Reference Type
                                                                            (required to http://ema.europa.eu/fhir/vs/productcrossreferencetype)
                                                                            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                                                            Is Modifierfalse
                                                                            Must Supportfalse
                                                                            Summarytrue
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            439. MedicinalProductDefinition.operation
                                                                            Definition

                                                                            A manufacturing or administrative process or step associated with (or performed on) the medicinal product.

                                                                            ShortA manufacturing or administrative process for the medicinal product
                                                                            Control0..*
                                                                            TypeBackboneElement
                                                                            Is Modifierfalse
                                                                            Must Supportfalse
                                                                            Summarytrue
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            441. MedicinalProductDefinition.operation.id
                                                                            Definition

                                                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                            ShortUnique id for inter-element referencing
                                                                            Control0..1
                                                                            This element is affected by the following invariants: ele-1
                                                                            Typestring
                                                                            Is Modifierfalse
                                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                                            Summaryfalse
                                                                            443. MedicinalProductDefinition.operation.extension
                                                                            Definition

                                                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                            ShortAdditional content defined by implementations
                                                                            Comments

                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                            Control0..*
                                                                            TypeExtension
                                                                            Is Modifierfalse
                                                                            Summaryfalse
                                                                            Alternate Namesextensions, user content
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                            445. MedicinalProductDefinition.operation.modifierExtension
                                                                            Definition

                                                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                            ShortExtensions that cannot be ignored even if unrecognized
                                                                            Comments

                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                            Control0..*
                                                                            TypeExtension
                                                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                            Summarytrue
                                                                            Requirements

                                                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                            Alternate Namesextensions, user content, modifiers
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                            447. MedicinalProductDefinition.operation.type
                                                                            Definition

                                                                            The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here.

                                                                            ShortThe type of manufacturing operation e.g. manufacturing itself, re-packaging
                                                                            Control0..1
                                                                            TypeCodeableReference(EMA Write API ActivityDefinition)
                                                                            Is Modifierfalse
                                                                            Must Supportfalse
                                                                            Summarytrue
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            449. MedicinalProductDefinition.operation.effectiveDate
                                                                            Definition

                                                                            Date range of applicability.

                                                                            ShortDate range of applicability
                                                                            Control0..1
                                                                            TypePeriod
                                                                            Is Modifierfalse
                                                                            Must Supportfalse
                                                                            Summarytrue
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            451. MedicinalProductDefinition.operation.organization
                                                                            Definition

                                                                            The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent.

                                                                            ShortThe organization responsible for the particular process, e.g. the manufacturer or importer
                                                                            Control0..*
                                                                            TypeReference(Organization)
                                                                            Is Modifierfalse
                                                                            Must Supportfalse
                                                                            Summarytrue
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            453. MedicinalProductDefinition.operation.confidentialityIndicator
                                                                            Definition

                                                                            Specifies whether this particular business or manufacturing process is considered proprietary or confidential.

                                                                            ShortSpecifies whether this process is considered proprietary or confidential
                                                                            Control0..1
                                                                            BindingThe codes SHALL be taken from Data Classification
                                                                            (required to http://ema.europa.eu/fhir/vs/dataClassification)
                                                                            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                                                            Is Modifierfalse
                                                                            Must Supportfalse
                                                                            Summarytrue
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            455. MedicinalProductDefinition.characteristic
                                                                            Definition

                                                                            Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import".

                                                                            ShortKey product features such as "sugar free", "modified release"
                                                                            Control1..1
                                                                            TypeBackboneElement
                                                                            Is Modifierfalse
                                                                            Must Supportfalse
                                                                            Summarytrue
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            457. MedicinalProductDefinition.characteristic.id
                                                                            Definition

                                                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                                            ShortUnique id for inter-element referencing
                                                                            Control0..1
                                                                            This element is affected by the following invariants: ele-1
                                                                            Typestring
                                                                            Is Modifierfalse
                                                                            XML FormatIn the XML format, this property is represented as an attribute.
                                                                            Summaryfalse
                                                                            459. MedicinalProductDefinition.characteristic.extension
                                                                            Definition

                                                                            May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

                                                                            ShortAdditional content defined by implementations
                                                                            Comments

                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                            Control0..*
                                                                            TypeExtension
                                                                            Is Modifierfalse
                                                                            Summaryfalse
                                                                            Alternate Namesextensions, user content
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                            461. MedicinalProductDefinition.characteristic.modifierExtension
                                                                            Definition

                                                                            May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

                                                                            Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).

                                                                            ShortExtensions that cannot be ignored even if unrecognized
                                                                            Comments

                                                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                                                            Control0..*
                                                                            TypeExtension
                                                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                                            Summarytrue
                                                                            Requirements

                                                                            Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.

                                                                            Alternate Namesextensions, user content, modifiers
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                                                            463. MedicinalProductDefinition.characteristic.type
                                                                            Definition

                                                                            A code expressing the type of characteristic.

                                                                            ShortA code expressing the type of characteristic
                                                                            Control1..1
                                                                            BindingFor example codes, see ProductCharacteristic
                                                                            (example to http://hl7.org/fhir/ValueSet/product-characteristic-codes)

                                                                            This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

                                                                            TypeCodeableConcept(EMA Genetically Modified Organisms CodeableConcept)
                                                                            Is Modifierfalse
                                                                            Must Supportfalse
                                                                            Summarytrue
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                                            465. MedicinalProductDefinition.characteristic.value[x]
                                                                            Definition

                                                                            A value for the characteristic.text.

                                                                            ShortA value for the characteristic
                                                                            Comments

                                                                            Text, as markdown, is intended to be used only when the item cannot ever reasonably be coded. Otherwise, for cases where a code is not available, but is feasible, use CodeableConcept.text.

                                                                            Control0..1
                                                                            TypeChoice of: CodeableConcept, markdown, Quantity, integer, date, boolean, Attachment
                                                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                                                            Is Modifierfalse
                                                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                                            Must Supportfalse
                                                                            Summarytrue
                                                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))