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

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

Resource Profile: EmaWriteApiPackagedProductDefinition - Detailed Descriptions

Draft as of 2025-08-08

Definitions for the emaWriteApiPackagedProductDefinition resource profile.

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

0. PackagedProductDefinition
Definition

A medically related item or items, in a container or package.

ShortA medically related item or items, in a container or package
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. PackagedProductDefinition.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..01
TypeMeta
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. PackagedProductDefinition.implicitRules
Definition

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

ShortA set of rules under which this content was created
Comments

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

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

The base language in which the resource is written.

ShortLanguage of the resource content
Comments

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

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

IETF language tag for a human language

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

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

ShortText summary of the resource, for human interpretation
Comments

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

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

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

ShortContained, inline Resources
Comments

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

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

An Extension


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.

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
Must Supportfalse
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())
14. PackagedProductDefinition.modifierExtension
Definition

An Extension


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

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

ShortExtensionExtensions that cannot be ignored
Comments

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

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

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

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

A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.

ShortA unique identifier for this package as whole - not for the content of the package
NoteThis is a business identifier, not a resource identifier (see discussion)
Control0..2*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
onlyOneDataCarrierIdentifier: Only one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present (exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030').toInteger() <= 1)
SlicingThis element introduces a set of slices on PackagedProductDefinition.identifier. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
  • value @ system
  • 18. PackagedProductDefinition.identifier:emaPcIdentifier
    Slice NameemaPcIdentifier
    Definition

    A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.

    ShortA unique identifier for this package as whole - not for the content of the package
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control0..1*
    TypeIdentifier(EMA PC Identifier)
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    20. PackagedProductDefinition.identifier:emaPcIdentifier.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 PackagedProductDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ url
    • 22. PackagedProductDefinition.identifier:emaPcIdentifier.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()))
      24. PackagedProductDefinition.identifier:emaPcIdentifier.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()))
      26. PackagedProductDefinition.identifier:emaPcIdentifier.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/pcId
      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()))
      28. PackagedProductDefinition.identifier:emaPcIdentifier.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()))
      30. PackagedProductDefinition.identifier:emaPcIdentifier.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()))
      32. PackagedProductDefinition.identifier:emaPcIdentifier.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()))
      34. PackagedProductDefinition.identifier:dataCarrierGs1
      Slice NamedataCarrierGs1
      Definition

      A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.

      ShortA unique identifier for this package as whole - not for the content of the package
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..1*
      TypeIdentifier
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      36. PackagedProductDefinition.identifier:dataCarrierGs1.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 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()))
      38. PackagedProductDefinition.identifier:dataCarrierGs1.system
      Definition

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

      ShortThe namespace for the identifier value
      Comments

      Identifier.system is always case sensitive.

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

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

      Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575
      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()))
      40. PackagedProductDefinition.identifier:dataCarrierPharmacy
      Slice NamedataCarrierPharmacy
      Definition

      A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.

      ShortA unique identifier for this package as whole - not for the content of the package
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..1*
      TypeIdentifier
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      42. PackagedProductDefinition.identifier:dataCarrierPharmacy.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 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. PackagedProductDefinition.identifier:dataCarrierPharmacy.system
      Definition

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

      ShortThe namespace for the identifier value
      Comments

      Identifier.system is always case sensitive.

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

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

      Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029
      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()))
      46. PackagedProductDefinition.identifier:dataCarrierNationalTrade
      Slice NamedataCarrierNationalTrade
      Definition

      A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.

      ShortA unique identifier for this package as whole - not for the content of the package
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..1*
      TypeIdentifier
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      48. PackagedProductDefinition.identifier:dataCarrierNationalTrade.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 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()))
      50. PackagedProductDefinition.identifier:dataCarrierNationalTrade.system
      Definition

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

      ShortThe namespace for the identifier value
      Comments

      Identifier.system is always case sensitive.

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

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

      Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030
      Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      52. PackagedProductDefinition.name
      Definition

      A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc.

      ShortA name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
      Control0..01
      Typestring
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      54. PackagedProductDefinition.type
      Definition

      A high level category e.g. medicinal product, raw material, shipping/transport container, etc.

      ShortA high level category e.g. medicinal product, raw material, shipping container etc
      Control0..01
      BindingFor example codes, see PackageTypehttp://hl7.org/fhir/ValueSet/package-type
      (example to http://hl7.org/fhir/ValueSet/package-type)

      A high level categorisation of a package.

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

      The product this package model relates to, not the contents of the package (for which see package.containedItem).

      ShortThe product that this is a pack for
      Control10..1*
      TypeReference(EMA Write API MedicinalProductDefinition, MedicinalProductDefinition)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      58. PackagedProductDefinition.status
      Definition

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

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

      The date at which the given status became applicable.

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

      Textual description. Note that this is not the name of the package or product.

      ShortTextual description. Note that this is not the name of the package or product
      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. PackagedProductDefinition.description.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. PackagedProductDefinition.marketingStatus
      Definition

      Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.

      ShortAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
      Control10..*
      TypeMarketingStatus
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      68. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortage
      Slice NameriskOfSupplyShortage
      Definition

      Risk of Supply Shortage

      ShortRisk of Supply Shortage
      Control0..1
      TypeExtension(Risk of Supply Shortage) (Extension Type: boolean)
      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())
      70. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortageComment
      Slice NameriskOfSupplyShortageComment
      Definition

      Risk of Supply Shortage Comment

      ShortRisk of Supply Shortage Comment
      Control0..1
      TypeExtension(Risk of Supply Shortage Comment) (Extension Type: string)
      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())
      72. PackagedProductDefinition.marketingStatus.extension:marketingStatusReason
      Slice NamemarketingStatusReason
      Definition

      Marketing Status Reason

      ShortMarketing Status Reason
      Control0..1
      TypeExtension(Marketing Status Reason) (Extension Type: Coding(EMA Coding))
      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())
      74. PackagedProductDefinition.marketingStatus.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())
      76. PackagedProductDefinition.marketingStatus.country
      Definition

      The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements.

      ShortThe country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
      Control10..1
      BindingThe codes SHALL be taken from For codes, see Country
      (required to http://ema.europa.eu/fhir/vs/country)
      TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      78. PackagedProductDefinition.marketingStatus.status
      Definition

      This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples.

      ShortThis attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
      Control1..1
      BindingThe codes SHALL be taken from For codes, see Marketing Status
      (required to http://ema.europa.eu/fhir/vs/marketingStatus)
      TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
      Is Modifierfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      80. PackagedProductDefinition.copackagedIndicator
      Definition

      Identifies if the package contains different items, such as when a drug product is supplied with another item e.g. a diluent or adjuvant.

      ShortIdentifies if the drug product is supplied with another item such as a diluent or adjuvant
      Control0..01
      Typeboolean
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Meaning if MissingIf this value is not present, there is no statement being made about whether this is co-packaged or not. No inference can be made
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      82. PackagedProductDefinition.attachedDocument
      Definition

      Additional information or supporting documentation about the packaged product.

      ShortAdditional information or supporting documentation about the packaged product
      Control0..0*
      TypeReference(DocumentReference)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      84. PackagedProductDefinition.characteristic
      Definition

      Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack".

      ShortAllows the key features to be recorded, such as "hospital pack", "nurse prescribable"
      Control0..0*
      TypeSeettp://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging.property
      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. PackagedProductDefinition
      2. PackagedProductDefinition.identifier
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..2
      InvariantsonlyOneDataCarrierIdentifier: Only one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present (exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030').toInteger() <= 1)
      SlicingThis element introduces a set of slices on PackagedProductDefinition.identifier. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
      • value @ system
      • 4. PackagedProductDefinition.identifier:emaPcIdentifier
        Slice NameemaPcIdentifier
        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..1
        TypeIdentifier(EMA PC Identifier)
        6. PackagedProductDefinition.identifier:emaPcIdentifier.system
        Control1..?
        Pattern Valuehttp://ema.europa.eu/fhir/pcId
        8. PackagedProductDefinition.identifier:dataCarrierGs1
        Slice NamedataCarrierGs1
        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..1
        10. PackagedProductDefinition.identifier:dataCarrierGs1.system
        Control1..?
        Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575
        12. PackagedProductDefinition.identifier:dataCarrierPharmacy
        Slice NamedataCarrierPharmacy
        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..1
        14. PackagedProductDefinition.identifier:dataCarrierPharmacy.system
        Control1..?
        Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029
        16. PackagedProductDefinition.identifier:dataCarrierNationalTrade
        Slice NamedataCarrierNationalTrade
        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..1
        18. PackagedProductDefinition.identifier:dataCarrierNationalTrade.system
        Control1..?
        Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030
        20. PackagedProductDefinition.packageFor
        Control1..1
        TypeReference(EMA Write API MedicinalProductDefinition)
        22. PackagedProductDefinition.status
        Control1..?
        BindingThe codes SHALL be taken from Record Status
        (required to http://ema.europa.eu/fhir/vs/recordStatus)
        TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
        24. PackagedProductDefinition.containedItemQuantity
        26. PackagedProductDefinition.containedItemQuantity.value
        Control1..?
        28. PackagedProductDefinition.containedItemQuantity.system
        Control1..?
        Pattern Valuehttp://spor.ema.europa.eu/v1/lists/200000000014
        30. PackagedProductDefinition.containedItemQuantity.code
        Control1..?
        BindingThe codes SHALL be taken from Units of Presentation
        (required to http://ema.europa.eu/fhir/vs/unitsOfPresentation)
        32. PackagedProductDefinition.description
        Control1..?
        34. PackagedProductDefinition.description.extension
        Control1..1
        TypeExtension(Language) (Extension Type: Coding(EMA Coding))
        36. PackagedProductDefinition.legalStatusOfSupply
        38. PackagedProductDefinition.legalStatusOfSupply.code
        BindingThe codes SHALL be taken from Legal Status of Supply
        (required to http://ema.europa.eu/fhir/vs/legalStatusForTheSupply)
        TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
        40. PackagedProductDefinition.marketingStatus
        Control1..?
        42. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortage
        Slice NameriskOfSupplyShortage
        Control0..1
        TypeExtension(Risk of Supply Shortage) (Extension Type: boolean)
        44. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortageComment
        Slice NameriskOfSupplyShortageComment
        Control0..1
        TypeExtension(Risk of Supply Shortage Comment) (Extension Type: string)
        46. PackagedProductDefinition.marketingStatus.extension:marketingStatusReason
        Slice NamemarketingStatusReason
        Control0..1
        TypeExtension(Marketing Status Reason) (Extension Type: Coding(EMA Coding))
        48. PackagedProductDefinition.marketingStatus.country
        Control1..?
        BindingThe codes SHALL be taken from Country
        (required to http://ema.europa.eu/fhir/vs/country)
        TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
        50. PackagedProductDefinition.marketingStatus.status
        BindingThe codes SHALL be taken from Marketing Status
        (required to http://ema.europa.eu/fhir/vs/marketingStatus)
        TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
        52. PackagedProductDefinition.marketingStatus.dateRange
        54. PackagedProductDefinition.marketingStatus.dateRange.start
        Control1..?
        56. PackagedProductDefinition.manufacturer
        58. PackagedProductDefinition.manufacturer.extension
        Control1..?
        TypeExtension(The Operation 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)
        60. PackagedProductDefinition.packaging
        62. PackagedProductDefinition.packaging.type
        Control1..?
        BindingThe codes SHALL be taken from Packaging
        (required to http://ema.europa.eu/fhir/vs/packaging)
        TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
        64. PackagedProductDefinition.packaging.quantity
        66. PackagedProductDefinition.packaging.quantity.extension
        Control1..1
        TypeExtension(The Comparator 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)
        68. PackagedProductDefinition.packaging.material
        Control1..?
        BindingThe codes SHALL be taken from Material
        (required to http://ema.europa.eu/fhir/vs/material)
        TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
        70. PackagedProductDefinition.packaging.shelfLifeStorage
        72. PackagedProductDefinition.packaging.shelfLifeStorage.type
        Control1..?
        BindingThe codes SHALL be taken from Shelf Life Type
        (required to http://ema.europa.eu/fhir/vs/shelfLifeType)
        TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
        74. PackagedProductDefinition.packaging.shelfLifeStorage.period[x]
        Control1..?
        TypeDuration(EMA Duration)
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        76. PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage
        BindingThe codes SHALL be taken from Special Precautions For Storage
        (required to http://ema.europa.eu/fhir/vs/specialPrecautionsForStorage)
        TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
        78. PackagedProductDefinition.packaging.manufacturer
        80. PackagedProductDefinition.packaging.manufacturer.extension
        Control1..?
        82. PackagedProductDefinition.packaging.manufacturer.extension.extension
        Control0..0
        84. PackagedProductDefinition.packaging.manufacturer.extension.value[x]
        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
        SlicingThis element introduces a set of slices on PackagedProductDefinition.packaging.manufacturer.extension.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • type @ $this
        • 86. PackagedProductDefinition.packaging.manufacturer.extension.value[x]:valueReference
          Slice NamevalueReference
          Control0..1
          TypeReference(EMA Write API ActivityDefinition)
          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
          88. PackagedProductDefinition.packaging.containedItem
          90. PackagedProductDefinition.packaging.containedItem.item
          TypeCodeableReference(DeviceDefinition, ManufacturedItemDefinition)
          92. PackagedProductDefinition.packaging.containedItem.amount
          Control1..?
          TypeQuantity(EMA Quantity)

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

          0. PackagedProductDefinition
          Definition

          A medically related item or items, in a container or package.

          ShortA medically related item or items, in a container or package
          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. PackagedProductDefinition.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. PackagedProductDefinition.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..0
          TypeMeta
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          6. PackagedProductDefinition.implicitRules
          Definition

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

          ShortA set of rules under which this content was created
          Comments

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

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

          The base language in which the resource is written.

          ShortLanguage of the resource content
          Comments

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

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

          IETF language tag for a human language

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

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

          ShortText summary of the resource, for human interpretation
          Comments

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

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

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

          ShortContained, inline Resources
          Comments

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

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

          An Extension

          ShortExtension
          Control0..0
          TypeExtension
          Is Modifierfalse
          Must Supportfalse
          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())
          16. PackagedProductDefinition.modifierExtension
          Definition

          An Extension

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

          A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.

          ShortA unique identifier for this package as whole - not for the content of the package
          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control0..2
          TypeIdentifier
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          onlyOneDataCarrierIdentifier: Only one of the three data carrier identifiers (GS1, Pharmacy, National Trade) may be present (exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029').toInteger() + exists(system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030').toInteger() <= 1)
          SlicingThis element introduces a set of slices on PackagedProductDefinition.identifier. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
          • value @ system
          • 20. PackagedProductDefinition.identifier:emaPcIdentifier
            Slice NameemaPcIdentifier
            Definition

            A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.

            ShortA unique identifier for this package as whole - not for the content of the package
            NoteThis is a business identifier, not a resource identifier (see discussion)
            Control0..1
            TypeIdentifier(EMA PC Identifier)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            22. PackagedProductDefinition.identifier:emaPcIdentifier.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
            24. PackagedProductDefinition.identifier:emaPcIdentifier.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 PackagedProductDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • value @ url
            • 26. PackagedProductDefinition.identifier:emaPcIdentifier.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()))
              28. PackagedProductDefinition.identifier:emaPcIdentifier.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()))
              30. PackagedProductDefinition.identifier:emaPcIdentifier.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/pcId
              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. PackagedProductDefinition.identifier:emaPcIdentifier.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()))
              34. PackagedProductDefinition.identifier:emaPcIdentifier.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()))
              36. PackagedProductDefinition.identifier:emaPcIdentifier.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()))
              38. PackagedProductDefinition.identifier:dataCarrierGs1
              Slice NamedataCarrierGs1
              Definition

              A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.

              ShortA unique identifier for this package as whole - not for the content of the package
              NoteThis is a business identifier, not a resource identifier (see discussion)
              Control0..1
              TypeIdentifier
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              40. PackagedProductDefinition.identifier:dataCarrierGs1.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
              42. PackagedProductDefinition.identifier:dataCarrierGs1.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 PackagedProductDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
              • value @ url
              • 44. PackagedProductDefinition.identifier:dataCarrierGs1.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()))
                46. PackagedProductDefinition.identifier:dataCarrierGs1.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()))
                48. PackagedProductDefinition.identifier:dataCarrierGs1.system
                Definition

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

                ShortThe namespace for the identifier value
                Comments

                Identifier.system is always case sensitive.

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

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

                Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575
                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()))
                50. PackagedProductDefinition.identifier:dataCarrierGs1.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()))
                52. PackagedProductDefinition.identifier:dataCarrierGs1.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()))
                54. PackagedProductDefinition.identifier:dataCarrierGs1.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()))
                56. PackagedProductDefinition.identifier:dataCarrierPharmacy
                Slice NamedataCarrierPharmacy
                Definition

                A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.

                ShortA unique identifier for this package as whole - not for the content of the package
                NoteThis is a business identifier, not a resource identifier (see discussion)
                Control0..1
                TypeIdentifier
                Is Modifierfalse
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                58. PackagedProductDefinition.identifier:dataCarrierPharmacy.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
                60. PackagedProductDefinition.identifier:dataCarrierPharmacy.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 PackagedProductDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 62. PackagedProductDefinition.identifier:dataCarrierPharmacy.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()))
                  64. PackagedProductDefinition.identifier:dataCarrierPharmacy.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()))
                  66. PackagedProductDefinition.identifier:dataCarrierPharmacy.system
                  Definition

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

                  ShortThe namespace for the identifier value
                  Comments

                  Identifier.system is always case sensitive.

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

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

                  Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029
                  Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  68. PackagedProductDefinition.identifier:dataCarrierPharmacy.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()))
                  70. PackagedProductDefinition.identifier:dataCarrierPharmacy.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()))
                  72. PackagedProductDefinition.identifier:dataCarrierPharmacy.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()))
                  74. PackagedProductDefinition.identifier:dataCarrierNationalTrade
                  Slice NamedataCarrierNationalTrade
                  Definition

                  A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.

                  ShortA unique identifier for this package as whole - not for the content of the package
                  NoteThis is a business identifier, not a resource identifier (see discussion)
                  Control0..1
                  TypeIdentifier
                  Is Modifierfalse
                  Must Supportfalse
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  76. PackagedProductDefinition.identifier:dataCarrierNationalTrade.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
                  78. PackagedProductDefinition.identifier:dataCarrierNationalTrade.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 PackagedProductDefinition.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 80. PackagedProductDefinition.identifier:dataCarrierNationalTrade.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()))
                    82. PackagedProductDefinition.identifier:dataCarrierNationalTrade.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()))
                    84. PackagedProductDefinition.identifier:dataCarrierNationalTrade.system
                    Definition

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

                    ShortThe namespace for the identifier value
                    Comments

                    Identifier.system is always case sensitive.

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

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

                    Pattern Valuehttp://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030
                    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()))
                    86. PackagedProductDefinition.identifier:dataCarrierNationalTrade.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()))
                    88. PackagedProductDefinition.identifier:dataCarrierNationalTrade.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()))
                    90. PackagedProductDefinition.identifier:dataCarrierNationalTrade.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()))
                    92. PackagedProductDefinition.name
                    Definition

                    A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc.

                    ShortA name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
                    Control0..0
                    Typestring
                    Is Modifierfalse
                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    94. PackagedProductDefinition.type
                    Definition

                    A high level category e.g. medicinal product, raw material, shipping/transport container, etc.

                    ShortA high level category e.g. medicinal product, raw material, shipping container etc
                    Control0..0
                    BindingFor example codes, see PackageType
                    (example to http://hl7.org/fhir/ValueSet/package-type)

                    A high level categorisation of a package.

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

                    The product this package model relates to, not the contents of the package (for which see package.containedItem).

                    ShortThe product that this is a pack for
                    Control1..1
                    TypeReference(EMA Write API MedicinalProductDefinition)
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    98. PackagedProductDefinition.status
                    Definition

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

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

                    The date at which the given status became applicable.

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

                    A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource.

                    ShortA total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
                    Control0..*
                    TypeQuantity
                    Is Modifierfalse
                    Must Supportfalse
                    Summarytrue
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    104. PackagedProductDefinition.containedItemQuantity.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
                    106. PackagedProductDefinition.containedItemQuantity.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 PackagedProductDefinition.containedItemQuantity.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • value @ url
                    • 108. PackagedProductDefinition.containedItemQuantity.value
                      Definition

                      The value of the measured amount. The value includes an implicit precision in the presentation of the value.

                      ShortNumerical value (with implicit precision)
                      Comments

                      The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books).

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

                      Precision is handled implicitly in almost all cases of measurement.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      110. PackagedProductDefinition.containedItemQuantity.comparator
                      Definition

                      How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value.

                      Short< | <= | >= | > | ad - how to understand the value
                      Control0..1
                      BindingThe codes SHALL be taken from QuantityComparator
                      (required to http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0)

                      How the Quantity should be understood and represented.

                      Typecode
                      Is Modifiertrue because This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summarytrue
                      Requirements

                      Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology.

                      Meaning if MissingIf there is no comparator, then there is no modification of the value
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      112. PackagedProductDefinition.containedItemQuantity.unit
                      Definition

                      A human-readable form of the unit.

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

                      There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      114. PackagedProductDefinition.containedItemQuantity.system
                      Definition

                      The identification of the system that provides the coded form of the unit.

                      ShortSystem that defines coded unit form
                      Control1..1
                      This element is affected by the following invariants: qty-3
                      Typeuri
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summarytrue
                      Requirements

                      Need to know the system that defines the coded form of the unit.

                      Pattern Valuehttp://spor.ema.europa.eu/v1/lists/200000000014
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      116. PackagedProductDefinition.containedItemQuantity.code
                      Definition

                      A computer processable form of the unit in some unit representation system.

                      ShortCoded form of the unit
                      Comments

                      The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system.

                      Control1..1
                      This element is affected by the following invariants: qty-3
                      BindingThe codes SHALL be taken from Units of Presentation
                      (required to http://ema.europa.eu/fhir/vs/unitsOfPresentation)
                      Typecode
                      Is Modifierfalse
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Summarytrue
                      Requirements

                      Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest.

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      118. PackagedProductDefinition.description
                      Definition

                      Textual description. Note that this is not the name of the package or product.

                      ShortTextual description. Note that this is not the name of the package or product
                      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()))
                      120. PackagedProductDefinition.description.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
                      122. PackagedProductDefinition.description.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())
                      124. PackagedProductDefinition.description.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
                      126. PackagedProductDefinition.legalStatusOfSupply
                      Definition

                      The legal status of supply of the packaged item as classified by the regulator.

                      ShortThe legal status of supply of the packaged item as classified by the regulator
                      Control0..*
                      TypeBackboneElement
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      128. PackagedProductDefinition.legalStatusOfSupply.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
                      130. PackagedProductDefinition.legalStatusOfSupply.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())
                      132. PackagedProductDefinition.legalStatusOfSupply.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())
                      134. PackagedProductDefinition.legalStatusOfSupply.code
                      Definition

                      The actual status of supply. Conveys in what situation this package type may be supplied for use.

                      ShortThe actual status of supply. In what situation this package type may be supplied for use
                      Control0..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()))
                      136. PackagedProductDefinition.legalStatusOfSupply.jurisdiction
                      Definition

                      The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context.

                      ShortThe place where the legal status of supply 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()))
                      138. PackagedProductDefinition.marketingStatus
                      Definition

                      Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.

                      ShortAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
                      Control1..*
                      TypeMarketingStatus
                      Is Modifierfalse
                      Must Supportfalse
                      Summarytrue
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      140. PackagedProductDefinition.marketingStatus.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
                      142. PackagedProductDefinition.marketingStatus.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 PackagedProductDefinition.marketingStatus.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • value @ url
                      • 144. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortage
                        Slice NameriskOfSupplyShortage
                        Definition

                        Risk of Supply Shortage

                        ShortRisk of Supply Shortage
                        Control0..1
                        TypeExtension(Risk of Supply Shortage) (Extension Type: boolean)
                        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())
                        146. PackagedProductDefinition.marketingStatus.extension:riskOfSupplyShortageComment
                        Slice NameriskOfSupplyShortageComment
                        Definition

                        Risk of Supply Shortage Comment

                        ShortRisk of Supply Shortage Comment
                        Control0..1
                        TypeExtension(Risk of Supply Shortage Comment) (Extension Type: string)
                        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())
                        148. PackagedProductDefinition.marketingStatus.extension:marketingStatusReason
                        Slice NamemarketingStatusReason
                        Definition

                        Marketing Status Reason

                        ShortMarketing Status Reason
                        Control0..1
                        TypeExtension(Marketing Status Reason) (Extension Type: Coding(EMA Coding))
                        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())
                        150. PackagedProductDefinition.marketingStatus.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())
                        152. PackagedProductDefinition.marketingStatus.country
                        Definition

                        The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements.

                        ShortThe country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements
                        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
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        154. PackagedProductDefinition.marketingStatus.jurisdiction
                        Definition

                        Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified.

                        ShortWhere a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified
                        Control0..1
                        TypeCodeableConcept
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        156. PackagedProductDefinition.marketingStatus.status
                        Definition

                        This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples.

                        ShortThis attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
                        Control1..1
                        BindingThe codes SHALL be taken from Marketing Status
                        (required to http://ema.europa.eu/fhir/vs/marketingStatus)
                        TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        158. PackagedProductDefinition.marketingStatus.dateRange
                        Definition

                        The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.

                        ShortThe date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
                        Control0..1
                        TypePeriod
                        Is Modifierfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        160. PackagedProductDefinition.marketingStatus.dateRange.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
                        162. PackagedProductDefinition.marketingStatus.dateRange.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 PackagedProductDefinition.marketingStatus.dateRange.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 164. PackagedProductDefinition.marketingStatus.dateRange.start
                          Definition

                          The start of the period. The boundary is inclusive.

                          ShortStarting time with inclusive boundary
                          Comments

                          If the low element is missing, the meaning is that the low boundary is not known.

                          Control1..1
                          This element is affected by the following invariants: per-1
                          TypedateTime
                          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()))
                          166. PackagedProductDefinition.marketingStatus.dateRange.end
                          Definition

                          The end of the period. If the end of the period is missing, it means no end was known or planned at the time the instance was created. The start may be in the past, and the end date in the future, which means that period is expected/planned to end at that time.

                          ShortEnd time with inclusive boundary, if not ongoing
                          Comments

                          The end value includes any matching date/time. i.e. 2012-02-03T10:00:00 is in a period that has an end value of 2012-02-03.

                          Control0..1
                          This element is affected by the following invariants: per-1
                          TypedateTime
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Summarytrue
                          Meaning if MissingIf the end of the period is missing, it means that the period is ongoing
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          168. PackagedProductDefinition.marketingStatus.restoreDate
                          Definition

                          The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.

                          ShortThe date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain
                          Control0..1
                          TypedateTime
                          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()))
                          170. PackagedProductDefinition.copackagedIndicator
                          Definition

                          Identifies if the package contains different items, such as when a drug product is supplied with another item e.g. a diluent or adjuvant.

                          ShortIdentifies if the drug product is supplied with another item such as a diluent or adjuvant
                          Control0..0
                          Typeboolean
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supportfalse
                          Summarytrue
                          Meaning if MissingIf this value is not present, there is no statement being made about whether this is co-packaged or not. No inference can be made
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          172. PackagedProductDefinition.manufacturer
                          Definition

                          Manufacturer of this package type. When there are multiple it means these are all possible manufacturers.

                          ShortManufacturer of this package type (multiple means these are all possible manufacturers)
                          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()))
                          174. PackagedProductDefinition.manufacturer.id
                          Definition

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

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

                          The Operation Extension

                          ShortThe Operation Extension
                          Control1..*
                          TypeExtension(The Operation 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())
                          178. PackagedProductDefinition.manufacturer.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()))
                          180. PackagedProductDefinition.manufacturer.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()))
                          182. PackagedProductDefinition.manufacturer.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)
                          Control0..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()))
                          184. PackagedProductDefinition.manufacturer.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()))
                          186. PackagedProductDefinition.attachedDocument
                          Definition

                          Additional information or supporting documentation about the packaged product.

                          ShortAdditional information or supporting documentation about the packaged product
                          Control0..0
                          TypeReference(DocumentReference)
                          Is Modifierfalse
                          Must Supportfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          188. PackagedProductDefinition.packaging
                          Definition

                          A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item).

                          ShortA packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
                          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()))
                          190. PackagedProductDefinition.packaging.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
                          192. PackagedProductDefinition.packaging.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())
                          194. PackagedProductDefinition.packaging.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())
                          196. PackagedProductDefinition.packaging.identifier
                          Definition

                          A business identifier that is specific to this particular part of the packaging, often assigned by the manufacturer. Including possibly Data Carrier Identifier (a GS1 barcode).

                          ShortAn identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
                          NoteThis is a business identifier, not a resource identifier (see discussion)
                          Control0..*
                          TypeIdentifier
                          Is Modifierfalse
                          Must Supportfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          198. PackagedProductDefinition.packaging.type
                          Definition

                          The physical type of the container of the items.

                          ShortThe physical type of the container of the items
                          Control1..1
                          BindingThe codes SHALL be taken from Packaging
                          (required to http://ema.europa.eu/fhir/vs/packaging)
                          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()))
                          200. PackagedProductDefinition.packaging.componentPart
                          Definition

                          Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial). The latter type are designed be a container, but the former are not.

                          ShortIs this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)
                          Control0..1
                          Typeboolean
                          Is Modifierfalse
                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                          Must Supportfalse
                          Summarytrue
                          Meaning if MissingIf absent, it cannot be assumed that the item is packaging (a container) or a part of the packaging - it is just 'packaging'. Systems can sometimes infer this from the packaging.type (e.g. bottles are containers, bottle caps are not), or from the fact that a container will usually have other items within it (though it is possible that these exist but are not mentioned). Often the distinction is not critical - and can easily be understood by humans - but if that is necessary for machine processing it is recommended that this attribute is given a value.
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          202. PackagedProductDefinition.packaging.quantity
                          Definition

                          The quantity of packaging items contained at this layer of the package. This does not relate to the number of contained items but relates solely to the number of packaging items. When looking at the outermost layer it is always 1. If there are two boxes within, at the next layer it would be 2.

                          ShortThe quantity of this level of packaging in the package that contains it (with the outermost level being 1)
                          Control0..1
                          Typeinteger
                          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()))
                          204. PackagedProductDefinition.packaging.quantity.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
                          206. PackagedProductDefinition.packaging.quantity.extension
                          Definition

                          The Comparator Extension

                          ShortThe Comparator Extension
                          Control1..1
                          TypeExtension(The Comparator 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
                          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())
                          208. PackagedProductDefinition.packaging.quantity.value
                          Definition

                          The actual value

                          ShortPrimitive value for integer
                          Control0..1
                          Typeinteger
                          Is Modifierfalse
                          XML FormatIn the XML format, this property is represented as an attribute.
                          Summaryfalse
                          Min Value-2147483648
                          Max Value2147483647
                          210. PackagedProductDefinition.packaging.material
                          Definition

                          Material type of the package item.

                          ShortMaterial type of the package item
                          Control1..*
                          BindingThe codes SHALL be taken from Material
                          (required to http://ema.europa.eu/fhir/vs/material)
                          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()))
                          212. PackagedProductDefinition.packaging.alternateMaterial
                          Definition

                          A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material (e.g. different types of plastic for a blister sleeve).

                          ShortA possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material
                          Control0..*
                          BindingFor example codes, see PackageMaterial
                          (example to http://hl7.org/fhir/ValueSet/package-material)

                          A material used in the construction of packages and their components.

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

                          Shelf Life and storage information.

                          ShortShelf Life and storage information
                          Control0..*
                          TypeProductShelfLife
                          Is Modifierfalse
                          Must Supportfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          216. PackagedProductDefinition.packaging.shelfLifeStorage.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
                          218. PackagedProductDefinition.packaging.shelfLifeStorage.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 PackagedProductDefinition.packaging.shelfLifeStorage.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ url
                          • 220. PackagedProductDefinition.packaging.shelfLifeStorage.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())
                            222. PackagedProductDefinition.packaging.shelfLifeStorage.type
                            Definition

                            This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified.

                            ShortThis describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
                            Control1..1
                            BindingThe codes SHALL be taken from Shelf Life Type
                            (required to http://ema.europa.eu/fhir/vs/shelfLifeType)
                            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                            Is Modifierfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            224. PackagedProductDefinition.packaging.shelfLifeStorage.period[x]
                            Definition

                            The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used.

                            ShortThe shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
                            Control1..1
                            TypeDuration(EMA Duration)
                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                            Is Modifierfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            226. PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage
                            Definition

                            Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified.

                            ShortSpecial precautions for storage, if any, can be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
                            Control0..*
                            BindingThe codes SHALL be taken from Special Precautions For Storage
                            (required to http://ema.europa.eu/fhir/vs/specialPrecautionsForStorage)
                            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                            Is Modifierfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            228. PackagedProductDefinition.packaging.manufacturer
                            Definition

                            Manufacturer of this packaging item. When there are multiple values each one is a potential manufacturer of this packaging item.

                            ShortManufacturer of this packaging item (multiple means these are all potential manufacturers)
                            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()))
                            230. PackagedProductDefinition.packaging.manufacturer.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
                            232. PackagedProductDefinition.packaging.manufacturer.extension
                            Definition

                            An Extension

                            ShortExtension
                            Control1..*
                            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 PackagedProductDefinition.packaging.manufacturer.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 234. PackagedProductDefinition.packaging.manufacturer.extension.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
                              236. PackagedProductDefinition.packaging.manufacturer.extension.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 PackagedProductDefinition.packaging.manufacturer.extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • value @ url
                              • 238. PackagedProductDefinition.packaging.manufacturer.extension.url
                                Definition

                                Source of the definition for the extension code - a logical name or a URL.

                                Shortidentifies the meaning of the extension
                                Comments

                                The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.

                                Control1..1
                                Typeuri
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Summaryfalse
                                240. PackagedProductDefinition.packaging.manufacturer.extension.value[x]
                                Definition

                                Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                                ShortValue of extension
                                Control0..1
                                This element is affected by the following invariants: ext-1
                                TypeChoice 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
                                [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
                                Summaryfalse
                                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 PackagedProductDefinition.packaging.manufacturer.extension.value[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                • type @ $this
                                • 242. PackagedProductDefinition.packaging.manufacturer.extension.value[x]:valueReference
                                  Slice NamevalueReference
                                  Definition

                                  Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).

                                  ShortValue of extension
                                  Control0..1
                                  This element is affected by the following invariants: ext-1
                                  TypeReference(EMA Write API ActivityDefinition)
                                  [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                  Is Modifierfalse
                                  Summaryfalse
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  244. PackagedProductDefinition.packaging.manufacturer.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()))
                                  246. PackagedProductDefinition.packaging.manufacturer.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()))
                                  248. PackagedProductDefinition.packaging.manufacturer.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)
                                  Control0..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()))
                                  250. PackagedProductDefinition.packaging.manufacturer.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()))
                                  252. PackagedProductDefinition.packaging.property
                                  Definition

                                  General characteristics of this item.

                                  ShortGeneral characteristics of this item
                                  Control0..*
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  254. PackagedProductDefinition.packaging.property.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
                                  256. PackagedProductDefinition.packaging.property.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())
                                  258. PackagedProductDefinition.packaging.property.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())
                                  260. PackagedProductDefinition.packaging.property.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
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  262. PackagedProductDefinition.packaging.property.value[x]
                                  Definition

                                  A value for the characteristic.

                                  ShortA value for the characteristic
                                  Control0..1
                                  TypeChoice of: CodeableConcept, Quantity, 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()))
                                  264. PackagedProductDefinition.packaging.containedItem
                                  Definition

                                  The item(s) within the packaging.

                                  ShortThe item(s) within the packaging
                                  Control0..*
                                  TypeBackboneElement
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  266. PackagedProductDefinition.packaging.containedItem.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
                                  268. PackagedProductDefinition.packaging.containedItem.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())
                                  270. PackagedProductDefinition.packaging.containedItem.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())
                                  272. PackagedProductDefinition.packaging.containedItem.item
                                  Definition

                                  The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.packaging.packaging).

                                  ShortThe actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package
                                  Control1..1
                                  TypeCodeableReference(DeviceDefinition, ManufacturedItemDefinition)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  274. PackagedProductDefinition.packaging.containedItem.amount
                                  Definition

                                  The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition).

                                  ShortThe number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)
                                  Control1..1
                                  TypeQuantity(EMA Quantity)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  276. PackagedProductDefinition.packaging.packaging
                                  Definition

                                  Allows containers (and parts of containers) within containers, still as a part of a single packaged product. See also PackagedProductDefinition.packaging.containedItem.item(PackagedProductDefinition).

                                  ShortAllows containers (and parts of containers) within containers, still as a part of single packaged product
                                  Control0..*
                                  TypeSeettp://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  278. PackagedProductDefinition.characteristic
                                  Definition

                                  Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack".

                                  ShortAllows the key features to be recorded, such as "hospital pack", "nurse prescribable"
                                  Control0..0
                                  TypeSeettp://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging.property
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))