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

EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: EmaWriteApiMedicinalProductDefinition - Detailed Descriptions

Draft as of 2025-04-04

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..1
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.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..*
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
6. 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())
8. MedicinalProductDefinition.modifierExtension
Definition

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).

ShortExtensions 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..*
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())
10. 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..*
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
  • 12. 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
    • 14. 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()))
      16. 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()))
      18. 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()))
      20. 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()))
      22. 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()))
      24. 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
      • 26. 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()))
        28. 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()))
        30. 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()))
        32. 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()))
        34. 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()))
        36. 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()))
        38. 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()))
        40. 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
        • 42. 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()))
          44. 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()))
          46. 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()))
          48. 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()))
          50. 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()))
          52. 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()))
          54. MedicinalProductDefinition.type
          Definition

          Regulatory type, e.g. Investigational or Authorized.

          ShortRegulatory type, e.g. Investigational or Authorized
          Control10..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()))
          56. 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()))
          58. 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
          Control0..1
          BindingThe codes SHOULD be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status
          (preferred to http://hl7.org/fhir/ValueSet/publication-status)

          The lifecycle status of an artifact.

          TypeCodeableConcept
          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()))
          60. 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
          Control10..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()))
          62. 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()))
          64. 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())
          66. 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()))
          68. 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()))
          70. 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()))
          72. MedicinalProductDefinition.classification
          Definition

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

          ShortAllows the product to be classified by various systems
          Control40..*
          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
          • 74. 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
            Control10..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()))
            76. 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
            • 78. 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()))
              80. 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
              Control10..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()))
              82. 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
              • 84. 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()))
                86. 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()))
                88. 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())
                93. 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()))
                95. 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()))
                97. 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()))
                99. 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()))
                101. 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()))
                103. 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()))
                105. 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
                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 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()))
                107. 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
                • 109. 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()))
                  111. 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()))
                  113. 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
                  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()))
                  115. 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())
                  117. 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 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 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()))
                  119. 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(PractitionerRole, Organization)
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  121. 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()))
                  123. 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())
                  125. 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()))
                  127. 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()))
                  129. 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
                  • 131. 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())
                    133. 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()))
                    135. 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()))
                    137. 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()))
                    139. 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()))
                    141. 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())
                    143. 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()))
                    145. 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()))
                    147. 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()))
                    149. 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())
                    151. 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()))
                    153. 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()))
                    155. 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()))
                    157. 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())
                    159. 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()))
                    161. 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()))
                    163. 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()))
                    165. 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())
                    167. 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()))
                    169. 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()))
                    171. 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
                    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()))
                    173. 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())
                    175. 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()))
                    177. 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()))
                    179. 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()))
                    181. 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())
                    183. 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)
                    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.type
                      Control1..?
                      BindingThe codes SHALL be taken from Medicinal Product Type
                      (required to http://ema.europa.eu/fhir/vs/medicinalProductType)
                      TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                      26. MedicinalProductDefinition.domain
                      Control1..?
                      BindingThe codes SHALL be taken from Domain
                      (required to http://ema.europa.eu/fhir/vs/domain)
                      TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                      28. MedicinalProductDefinition.combinedPharmaceuticalDoseForm
                      Control1..?
                      BindingThe codes SHALL be taken from Combined Pharmaceutical Dose Form
                      (required to http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm)
                      TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                      30. MedicinalProductDefinition.indication
                      Control1..?
                      32. MedicinalProductDefinition.indication.extension
                      Control1..1
                      TypeExtension(Language) (Extension Type: Coding(EMA Coding))
                      34. 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)
                      36. 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)
                      38. 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)
                      40. MedicinalProductDefinition.classification
                      Control4..?
                      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
                      • 42. MedicinalProductDefinition.classification:xevmpd
                        Slice Namexevmpd
                        Control1..1
                        TypeCodeableConcept(EMA XEVMPD Product CodeableConcept)
                        44. MedicinalProductDefinition.classification:xevmpd.coding
                        46. MedicinalProductDefinition.classification:xevmpd.coding.system
                        Control1..?
                        Pattern Valuehttp://spor.ema.europa.eu/v1/lists/200000000324
                        48. MedicinalProductDefinition.classification:legalBasis
                        Slice NamelegalBasis
                        Control1..1
                        TypeCodeableConcept(EMA Legal Basis CodeableConcept)
                        50. MedicinalProductDefinition.classification:legalBasis.coding
                        52. MedicinalProductDefinition.classification:legalBasis.coding.system
                        Control1..?
                        Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000116045
                        54. MedicinalProductDefinition.classification:lightAtc
                        Slice NamelightAtc
                        Control1..*
                        TypeCodeableConcept(EMA Light ATC CodeableConcept)
                        56. MedicinalProductDefinition.classification:lightAtc.coding
                        58. MedicinalProductDefinition.classification:lightAtc.coding.system
                        Control1..?
                        Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000093533
                        60. MedicinalProductDefinition.classification:productCategory
                        Slice NameproductCategory
                        Control1..*
                        TypeCodeableConcept(EMA Product Category CodeableConcept)
                        62. MedicinalProductDefinition.classification:productCategory.coding
                        64. MedicinalProductDefinition.classification:productCategory.coding.system
                        Control1..?
                        Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000155526
                        66. MedicinalProductDefinition.masterFile
                        Control1..1
                        68. MedicinalProductDefinition.contact
                        Control0..1
                        70. MedicinalProductDefinition.contact.type
                        TypeCodeableConcept(EMA Qualified Person Type CodeableConcept)
                        72. MedicinalProductDefinition.contact.contact
                        TypeReference(PractitionerRole)
                        74. MedicinalProductDefinition.name
                        Control0..1
                        76. 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)
                        78. 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
                        • 80. MedicinalProductDefinition.name.part.type
                          82. 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)
                          84. MedicinalProductDefinition.name.part:inventedName
                          Slice NameinventedName
                          Control0..1
                          86. MedicinalProductDefinition.name.part:inventedName.type
                          Pattern Value{
                            "coding" : [{
                              "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                              "code" : "220000000002"
                            }]
                          }
                          88. MedicinalProductDefinition.name.part:fullName
                          Slice NamefullName
                          Control0..1
                          90. MedicinalProductDefinition.name.part:fullName.type
                          Pattern Value{
                            "coding" : [{
                              "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                              "code" : "220000000001"
                            }]
                          }
                          92. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm
                          Slice NamepharmaceuticalDoseForm
                          Control0..1
                          94. MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type
                          Pattern Value{
                            "coding" : [{
                              "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                              "code" : "220000000005"
                            }]
                          }
                          96. MedicinalProductDefinition.name.usage
                          Control1..1
                          98. 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)
                          100. MedicinalProductDefinition.name.usage.language
                          BindingThe codes SHALL be taken from Language
                          (required to http://ema.europa.eu/fhir/vs/language)
                          102. MedicinalProductDefinition.crossReference
                          Control1..1
                          104. MedicinalProductDefinition.crossReference.product
                          106. MedicinalProductDefinition.crossReference.product.reference
                          108. MedicinalProductDefinition.crossReference.product.reference.identifier
                          NoteThis is a business identifier, not a resource identifier (see discussion)
                          Control1..?
                          110. MedicinalProductDefinition.crossReference.product.reference.identifier.system
                          Pattern Valuehttp://ema.europa.eu/fhir/crossReference
                          112. 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)
                          114. MedicinalProductDefinition.operation
                          116. MedicinalProductDefinition.operation.type
                          TypeCodeableReference(EMA Write API ActivityDefinition)
                          118. 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)
                          120. MedicinalProductDefinition.characteristic
                          Control1..1
                          122. 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..1
                          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..1
                          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..1
                          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..*
                          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

                          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).

                          ShortExtensions 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..*
                          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())
                          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..*
                          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.type
                                  Definition

                                  Regulatory type, e.g. Investigational or Authorized.

                                  ShortRegulatory type, e.g. Investigational or Authorized
                                  Control1..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()))
                                  74. 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()))
                                  76. 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..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()))
                                  78. 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
                                  Control0..1
                                  BindingThe codes SHOULD be taken from PublicationStatus
                                  (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                  The lifecycle status of an artifact.

                                  TypeCodeableConcept
                                  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()))
                                  80. MedicinalProductDefinition.statusDate
                                  Definition

                                  The date at which the given status became applicable.

                                  ShortThe date at which the given status became applicable
                                  Control0..1
                                  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()))
                                  82. MedicinalProductDefinition.description
                                  Definition

                                  General description of this product.

                                  ShortGeneral description of this product
                                  Control0..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()))
                                  84. 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
                                  Control1..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()))
                                  86. 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..*
                                  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()))
                                  88. 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()))
                                  90. 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
                                  92. 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())
                                  94. 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
                                  96. 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()))
                                  98. 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()))
                                  100. 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..*
                                  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()))
                                  102. 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()))
                                  104. MedicinalProductDefinition.classification
                                  Definition

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

                                  ShortAllows the product to be classified by various systems
                                  Control4..*
                                  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
                                  • 106. 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
                                    Control1..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()))
                                    108. 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
                                    110. 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
                                    • 112. 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()))
                                      114. 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
                                      116. 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
                                      • 118. 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()))
                                        120. 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()))
                                        122. 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()))
                                        124. 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()))
                                        126. 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()))
                                        128. 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()))
                                        130. 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
                                        Control1..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()))
                                        132. 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
                                        134. 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
                                        • 136. 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()))
                                          138. 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
                                          140. 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
                                          • 142. 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()))
                                            144. 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()))
                                            146. 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()))
                                            148. 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()))
                                            150. 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()))
                                            152. 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()))
                                            154. 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()))
                                            156. 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
                                            158. 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())
                                            165. 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()))
                                            167. 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
                                            169. 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
                                            • 171. 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()))
                                              173. 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
                                              175. MedicinalProductDefinition.classification:lightAtc.coding.system.extension
                                              Definition

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

                                              ShortExtension
                                              Control0..*
                                              TypeExtension(CodeSystemName) (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())
                                              177. 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
                                              179. 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()))
                                              181. 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()))
                                              183. 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()))
                                              185. 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()))
                                              187. 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()))
                                              189. 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
                                              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 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()))
                                              191. 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
                                              193. 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
                                              • 195. 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()))
                                                197. 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
                                                199. 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
                                                • 201. 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()))
                                                  203. 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()))
                                                  205. 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()))
                                                  207. 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()))
                                                  209. 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()))
                                                  211. 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()))
                                                  213. 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..*
                                                  TypeMarketingStatus
                                                  Is Modifierfalse
                                                  Must Supportfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  215. MedicinalProductDefinition.packagedMedicinalProduct
                                                  Definition

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

                                                  ShortPackage type for the product
                                                  Control0..*
                                                  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()))
                                                  217. 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()))
                                                  219. 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..*
                                                  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()))
                                                  221. 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..*
                                                  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()))
                                                  223. 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()))
                                                  225. 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()))
                                                  227. 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
                                                  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()))
                                                  229. 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
                                                  231. 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())
                                                  233. 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())
                                                  235. 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(EMA 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()))
                                                  237. 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(PractitionerRole)
                                                  Is Modifierfalse
                                                  Must Supportfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  239. 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()))
                                                  241. 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..*
                                                  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()))
                                                  243. 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()))
                                                  245. 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
                                                  247. 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())
                                                  249. 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())
                                                  251. 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()))
                                                  253. 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()))
                                                  255. 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
                                                  • 257. 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
                                                    259. 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())
                                                    261. 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())
                                                    263. 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()))
                                                    265. 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()))
                                                    267. 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
                                                    269. 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
                                                    • 271. 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()))
                                                      273. 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()))
                                                      275. 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()))
                                                      277. 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
                                                      279. 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())
                                                      281. 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())
                                                      283. 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()))
                                                      285. 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()))
                                                      287. 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
                                                      289. 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
                                                      • 291. 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()))
                                                        293. 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()))
                                                        295. 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()))
                                                        297. 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
                                                        299. 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())
                                                        301. 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())
                                                        303. 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()))
                                                        305. 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()))
                                                        307. 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
                                                        309. 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
                                                        • 311. 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()))
                                                          313. 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()))
                                                          315. 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()))
                                                          317. 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
                                                          319. 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())
                                                          321. 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())
                                                          323. 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()))
                                                          325. 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()))
                                                          327. 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
                                                          329. 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
                                                          • 331. 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()))
                                                            333. 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()))
                                                            335. 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()))
                                                            337. 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
                                                            339. 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())
                                                            341. 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())
                                                            343. 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()))
                                                            345. 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()))
                                                            347. 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()))
                                                            349. 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
                                                            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()))
                                                            351. 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
                                                            353. 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())
                                                            355. 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())
                                                            357. 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()))
                                                            359. 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
                                                            361. 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
                                                            • 363. 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()))
                                                              365. 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()))
                                                              367. 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
                                                              369. 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
                                                              • 371. 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()))
                                                                373. 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()))
                                                                375. 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()))
                                                                377. 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
                                                                379. 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
                                                                • 381. 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()))
                                                                  383. 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()))
                                                                  385. 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()))
                                                                  387. 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()))
                                                                  389. 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()))
                                                                  391. 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()))
                                                                  393. 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()))
                                                                  395. 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()))
                                                                  397. 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()))
                                                                  399. 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
                                                                  401. 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())
                                                                  403. 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())
                                                                  405. 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()))
                                                                  407. 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()))
                                                                  409. 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()))
                                                                  411. 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()))
                                                                  413. 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()))
                                                                  415. 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
                                                                  417. 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())
                                                                  419. 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())
                                                                  421. 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()))
                                                                  423. 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()))