German (DEU) Electronic Product Information (ePI) Product Leaflet (PL) Implementation Guide
0.1.0 - ci-build

German (DEU) Electronic Product Information (ePI) Product Leaflet (PL) Implementation Guide - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: DEUePIPLPackagedProductDefinition - Detailed Descriptions

Draft as of 2025-06-13

Definitions for the DEUePIPLPackagedProductDefinition resource profile.

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

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.implicitRules
Definition

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

ShortA set of rules under which this content was created
Comments

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

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. 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..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
6. PackagedProductDefinition.modifierExtension
Definition

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

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

ShortExtensions that cannot be ignored
Comments

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

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

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

Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
8. 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.

ShortSliced to require GTIN, optionally allow PZN and ENR_IDA 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)
Control10..*
TypeIdentifier
Is Modifierfalse
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
SlicingThis element introduces a set of slices on PackagedProductDefinition.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ type.coding.code
  • 10. PackagedProductDefinition.identifier.use
    Definition

    The purpose of this identifier.

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

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

    Control0..1
    BindingThe codes SHALL be taken from 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()))
    12. PackagedProductDefinition.identifier.system
    Definition

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

    ShortThe namespace for the identifier value
    Comments

    Identifier.system is always case sensitive.

    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.

    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()))
    14. PackagedProductDefinition.identifier.value
    Definition

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

    ShortThe value that is unique
    Comments

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

    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()))
    16. PackagedProductDefinition.identifier:gtin
    Slice Namegtin
    Definition

    Mandatory GTIN identifier (e.g., 04150004540432)


    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.

    ShortGTIN (Global Trade Item Number)A 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)
    Control10..1*
    TypeIdentifier
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    18. PackagedProductDefinition.identifier:gtin.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()))
    20. PackagedProductDefinition.identifier:gtin.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 Valuehttps://gs1.org/gtin
    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()))
    22. PackagedProductDefinition.identifier:gtin.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()))
    24. PackagedProductDefinition.identifier:pzn
    Slice Namepzn
    Definition

    Optional PZN used mainly in Germany


    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.

    ShortPharmaceutical Central Number (PZN)A 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()))
    26. PackagedProductDefinition.identifier:pzn.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()))
    28. PackagedProductDefinition.identifier:pzn.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://fhir.de/sid/pzn
    Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    30. PackagedProductDefinition.identifier:pzn.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()))
    32. PackagedProductDefinition.identifier:enr-id
    Slice Nameenr-id
    Definition

    Optional ENR_ID (e.g., from PharmNet)


    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.

    ShortENR_ID (ENR + Pack Size)A 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()))
    34. PackagedProductDefinition.identifier:enr-id.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()))
    36. PackagedProductDefinition.identifier:enr-id.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.

    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()))
    38. PackagedProductDefinition.identifier:enr-id.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()))
    40. PackagedProductDefinition.name
    Definition

    Name of the packaged product, e.g., Transformium 200mg Tabletten 20St.


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

    ShortPackaged Product NameA name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
    Control10..1
    Typestring
    Is Modifierfalse
    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    42. PackagedProductDefinition.packageFor
    Definition

    Reference to the MedicinalProductDefinition resource (DEUePIPLMedicinalProductDefinition profile) for which this package is intended.


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

    ShortPackaged for Medicinal ProductThe product that this is a pack for
    Control10..1*
    TypeReference(03 DEU ePIL Medicinal Product Definition, MedicinalProductDefinition)
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    44. 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
    Control0..1
    BindingThe codes SHOULD be taken from PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status
    (preferred to http://hl7.org/fhir/ValueSet/publication-status)

    The lifecycle status of an artifact.

    TypeCodeableConcept
    Is Modifiertrue because This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    46. PackagedProductDefinition.containedItemQuantity
    Definition

    The quantity of items within the package, e.g., 100 Filmtabletten, 500 Gramm, or 200 Milliliters.


    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.

    ShortContained QuantityA 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)
    Control10..*
    TypeQuantity
    Is Modifierfalse
    Must Supporttrue
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    48. PackagedProductDefinition.manufacturer
    Definition

    Reference to the manufacturer organization (DEUePIPLOrganization profile).


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

    ShortManufacturerManufacturer of this package type (multiple means these are all possible manufacturers)
    Control10..1*
    TypeReference(02 DEU ePIL Organization, Organization)
    Is Modifierfalse
    Must Supporttrue
    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 foundhere

    0. PackagedProductDefinition
    2. PackagedProductDefinition.identifier
    ShortSliced to require GTIN, optionally allow PZN and ENR_ID
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control1..?
    SlicingThis element introduces a set of slices on PackagedProductDefinition.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ type.coding.code
    • 4. PackagedProductDefinition.identifier:gtin
      Slice Namegtin
      Definition

      Mandatory GTIN identifier (e.g., 04150004540432)

      ShortGTIN (Global Trade Item Number)
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control1..1
      6. PackagedProductDefinition.identifier:gtin.type
      8. PackagedProductDefinition.identifier:gtin.type.coding
      10. PackagedProductDefinition.identifier:gtin.type.coding.system
      Pattern Valuehttp://ema.europa.eu/fhir/CodeSystem/100000000009
      12. PackagedProductDefinition.identifier:gtin.type.coding.code
      Control1..?
      Pattern Value100000167575
      14. PackagedProductDefinition.identifier:gtin.type.coding.display
      Pattern ValueGS1 Global Trade Item Number
      16. PackagedProductDefinition.identifier:gtin.system
      Pattern Valuehttps://gs1.org/gtin
      18. PackagedProductDefinition.identifier:pzn
      Slice Namepzn
      Definition

      Optional PZN used mainly in Germany

      ShortPharmaceutical Central Number (PZN)
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..1
      20. PackagedProductDefinition.identifier:pzn.type
      22. PackagedProductDefinition.identifier:pzn.type.coding
      24. PackagedProductDefinition.identifier:pzn.type.coding.system
      Pattern Valuehttp://fhir.de/CodeSystem/ifa/pzn
      26. PackagedProductDefinition.identifier:pzn.type.coding.code
      Control1..?
      Pattern ValuePZN
      28. PackagedProductDefinition.identifier:pzn.system
      Pattern Valuehttp://fhir.de/sid/pzn
      30. PackagedProductDefinition.identifier:enr-id
      Slice Nameenr-id
      Definition

      Optional ENR_ID (e.g., from PharmNet)

      ShortENR_ID (ENR + Pack Size)
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..1
      32. PackagedProductDefinition.identifier:enr-id.type
      34. PackagedProductDefinition.identifier:enr-id.type.coding
      36. PackagedProductDefinition.identifier:enr-id.type.coding.code
      Control1..?
      Pattern ValueENR_ID
      38. PackagedProductDefinition.name
      Definition

      Name of the packaged product, e.g., Transformium 200mg Tabletten 20St.

      ShortPackaged Product Name
      Must Supporttrue
      40. PackagedProductDefinition.packageFor
      Definition

      Reference to the MedicinalProductDefinition resource (DEUePIPLMedicinalProductDefinition profile) for which this package is intended.

      ShortPackaged for Medicinal Product
      Control1..1
      TypeReference(03 DEU ePIL Medicinal Product Definition)
      Must Supporttrue
      42. PackagedProductDefinition.containedItemQuantity
      Definition

      The quantity of items within the package, e.g., 100 Filmtabletten, 500 Gramm, or 200 Milliliters.

      ShortContained Quantity
      Control1..?
      Must Supporttrue
      44. PackagedProductDefinition.manufacturer
      Definition

      Reference to the manufacturer organization (DEUePIPLOrganization profile).

      ShortManufacturer
      Control1..1
      TypeReference(02 DEU ePIL Organization)
      Must Supporttrue

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

      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..1
      TypeMeta
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      6. 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..1
      Typeuri
      Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      8. 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..1
      BindingThe codes SHALL be taken from AllLanguages
      (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

      IETF language tag for a human language

      Typecode
      Is Modifierfalse
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Must Supportfalse
      Summaryfalse
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      10. 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..1
      This element is affected by the following invariants: dom-6
      TypeNarrative
      Is Modifierfalse
      Must Supportfalse
      Summaryfalse
      Alternate Namesnarrative, html, xhtml, display
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      12. 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..*
      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

      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.

      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
      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())
      16. PackagedProductDefinition.modifierExtension
      Definition

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

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

      ShortExtensions that cannot be ignored
      Comments

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

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

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

      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      18. 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.

      ShortSliced to require GTIN, optionally allow PZN and ENR_ID
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control1..*
      TypeIdentifier
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      SlicingThis element introduces a set of slices on PackagedProductDefinition.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ type.coding.code
      • 20. PackagedProductDefinition.identifier.id
        Definition

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

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

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

        ShortAdditional content defined by implementations
        Comments

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

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

          The purpose of this identifier.

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

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

          Control0..1
          BindingThe codes SHALL be taken from IdentifierUse
          (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

          Identifies the purpose for this identifier, if known .

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

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

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

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

          ShortDescription of identifier
          Comments

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

          Control0..1
          BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
          (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

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

          TypeCodeableConcept
          Is Modifierfalse
          Summarytrue
          Requirements

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

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

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

          ShortThe namespace for the identifier value
          Comments

          Identifier.system is always case sensitive.

          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.

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

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

          ShortThe value that is unique
          Comments

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

          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()))
          32. PackagedProductDefinition.identifier.period
          Definition

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

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

          Organization that issued/manages the identifier.

          ShortOrganization that issued id (may be just text)
          Comments

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

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

          Mandatory GTIN identifier (e.g., 04150004540432)

          ShortGTIN (Global Trade Item Number)
          NoteThis is a business identifier, not a resource identifier (see discussion)
          Control1..1
          TypeIdentifier
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          38. PackagedProductDefinition.identifier:gtin.id
          Definition

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

          ShortUnique id for inter-element referencing
          Control0..1
          This element is affected by the following invariants: ele-1
          Typeid
          Is Modifierfalse
          XML FormatIn the XML format, this property is represented as an attribute.
          Summaryfalse
          40. PackagedProductDefinition.identifier:gtin.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
          • 42. PackagedProductDefinition.identifier:gtin.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()))
            44. PackagedProductDefinition.identifier:gtin.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()))
            46. PackagedProductDefinition.identifier:gtin.type.id
            Definition

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

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

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

            ShortAdditional content defined by implementations
            Comments

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

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

              A reference to a code defined by a terminology system.

              ShortCode defined by a terminology system
              Comments

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

              Control0..*
              TypeCoding
              Is Modifierfalse
              Summarytrue
              Requirements

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

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

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

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

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

              ShortAdditional content defined by implementations
              Comments

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

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

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

                ShortIdentity of the terminology system
                Comments

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

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

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

                Pattern Valuehttp://ema.europa.eu/fhir/CodeSystem/100000000009
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                58. PackagedProductDefinition.identifier:gtin.type.coding.version
                Definition

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

                ShortVersion of the system - if relevant
                Comments

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

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

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

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

                Need to refer to a particular code in the system.

                Pattern Value100000167575
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                62. PackagedProductDefinition.identifier:gtin.type.coding.display
                Definition

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

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

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

                Pattern ValueGS1 Global Trade Item Number
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                64. PackagedProductDefinition.identifier:gtin.type.coding.userSelected
                Definition

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

                ShortIf this coding was chosen directly by the user
                Comments

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

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

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

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

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

                ShortPlain text representation of the concept
                Comments

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

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

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

                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                68. PackagedProductDefinition.identifier:gtin.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 Valuehttps://gs1.org/gtin
                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()))
                70. PackagedProductDefinition.identifier:gtin.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()))
                72. PackagedProductDefinition.identifier:gtin.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()))
                74. PackagedProductDefinition.identifier:gtin.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()))
                76. PackagedProductDefinition.identifier:pzn
                Slice Namepzn
                Definition

                Optional PZN used mainly in Germany

                ShortPharmaceutical Central Number (PZN)
                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()))
                78. PackagedProductDefinition.identifier:pzn.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
                80. PackagedProductDefinition.identifier:pzn.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
                • 82. PackagedProductDefinition.identifier:pzn.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()))
                  84. PackagedProductDefinition.identifier:pzn.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()))
                  86. PackagedProductDefinition.identifier:pzn.type.id
                  Definition

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

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

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

                  ShortAdditional content defined by implementations
                  Comments

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

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

                    A reference to a code defined by a terminology system.

                    ShortCode defined by a terminology system
                    Comments

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

                    Control0..*
                    TypeCoding
                    Is Modifierfalse
                    Summarytrue
                    Requirements

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

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

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

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

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

                    ShortAdditional content defined by implementations
                    Comments

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

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

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

                      ShortIdentity of the terminology system
                      Comments

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

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

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

                      Pattern Valuehttp://fhir.de/CodeSystem/ifa/pzn
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      98. PackagedProductDefinition.identifier:pzn.type.coding.version
                      Definition

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

                      ShortVersion of the system - if relevant
                      Comments

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

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

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

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

                      Need to refer to a particular code in the system.

                      Pattern ValuePZN
                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      102. PackagedProductDefinition.identifier:pzn.type.coding.display
                      Definition

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

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

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

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      104. PackagedProductDefinition.identifier:pzn.type.coding.userSelected
                      Definition

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

                      ShortIf this coding was chosen directly by the user
                      Comments

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

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

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

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

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

                      ShortPlain text representation of the concept
                      Comments

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

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

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

                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                      108. PackagedProductDefinition.identifier:pzn.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://fhir.de/sid/pzn
                      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()))
                      110. PackagedProductDefinition.identifier:pzn.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()))
                      112. PackagedProductDefinition.identifier:pzn.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()))
                      114. PackagedProductDefinition.identifier:pzn.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()))
                      116. PackagedProductDefinition.identifier:enr-id
                      Slice Nameenr-id
                      Definition

                      Optional ENR_ID (e.g., from PharmNet)

                      ShortENR_ID (ENR + Pack Size)
                      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()))
                      118. PackagedProductDefinition.identifier:enr-id.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
                      120. PackagedProductDefinition.identifier:enr-id.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
                      • 122. PackagedProductDefinition.identifier:enr-id.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()))
                        124. PackagedProductDefinition.identifier:enr-id.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()))
                        126. PackagedProductDefinition.identifier:enr-id.type.id
                        Definition

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

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

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

                        ShortAdditional content defined by implementations
                        Comments

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

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

                          A reference to a code defined by a terminology system.

                          ShortCode defined by a terminology system
                          Comments

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

                          Control0..*
                          TypeCoding
                          Is Modifierfalse
                          Summarytrue
                          Requirements

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

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

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

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

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

                          ShortAdditional content defined by implementations
                          Comments

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

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

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

                            ShortIdentity of the terminology system
                            Comments

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

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

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

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            138. PackagedProductDefinition.identifier:enr-id.type.coding.version
                            Definition

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

                            ShortVersion of the system - if relevant
                            Comments

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

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

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

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

                            Need to refer to a particular code in the system.

                            Pattern ValueENR_ID
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            142. PackagedProductDefinition.identifier:enr-id.type.coding.display
                            Definition

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

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

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

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            144. PackagedProductDefinition.identifier:enr-id.type.coding.userSelected
                            Definition

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

                            ShortIf this coding was chosen directly by the user
                            Comments

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

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

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

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

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

                            ShortPlain text representation of the concept
                            Comments

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

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

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

                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            148. PackagedProductDefinition.identifier:enr-id.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.

                            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()))
                            150. PackagedProductDefinition.identifier:enr-id.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()))
                            152. PackagedProductDefinition.identifier:enr-id.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()))
                            154. PackagedProductDefinition.identifier:enr-id.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()))
                            156. PackagedProductDefinition.name
                            Definition

                            Name of the packaged product, e.g., Transformium 200mg Tabletten 20St.

                            ShortPackaged Product Name
                            Control1..1
                            Typestring
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supporttrue
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            158. 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 pack, sample pack, shipping container.
                            Control0..1
                            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()))
                            160. PackagedProductDefinition.packageFor
                            Definition

                            Reference to the MedicinalProductDefinition resource (DEUePIPLMedicinalProductDefinition profile) for which this package is intended.

                            ShortPackaged for Medicinal Product
                            Control1..1
                            TypeReference(03 DEU ePIL Medicinal Product Definition)
                            Is Modifierfalse
                            Must Supporttrue
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            162. 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
                            Control0..1
                            BindingThe codes SHOULD be taken from PublicationStatus
                            (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                            The lifecycle status of an artifact.

                            TypeCodeableConcept
                            Is Modifiertrue because This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid
                            Must Supportfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            164. PackagedProductDefinition.statusDate
                            Definition

                            The date at which the given status became applicable.

                            ShortThe date at which the given status became applicable
                            Control0..1
                            TypedateTime
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supportfalse
                            Summarytrue
                            Example<br/><b>Example of a status date</b>:2015-02-07T13:28:17Z
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            166. PackagedProductDefinition.containedItemQuantity
                            Definition

                            The quantity of items within the package, e.g., 100 Filmtabletten, 500 Gramm, or 200 Milliliters.

                            ShortContained Quantity
                            Control1..*
                            TypeQuantity
                            Is Modifierfalse
                            Must Supporttrue
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            168. PackagedProductDefinition.description
                            Definition

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

                            ShortNarrative description of the overall pack; e.g., description of a sample pack
                            Control0..1
                            Typemarkdown
                            Is Modifierfalse
                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                            Must Supportfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            170. 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()))
                            172. 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
                            174. 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())
                            176. 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())
                            178. 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
                            BindingFor example codes, see LegalStatusOfSupply
                            (example to http://hl7.org/fhir/ValueSet/legal-status-of-supply)

                            The prescription supply types appropriate to a medicinal product

                            TypeCodeableConcept
                            Is Modifierfalse
                            Must Supportfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            180. 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
                            BindingThe codes SHOULD be taken from ISO Country two letter code
                            (preferred to http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country)
                            TypeCodeableConcept
                            Is Modifierfalse
                            Must Supportfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            182. 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.
                            Control0..*
                            TypeMarketingStatus
                            Is Modifierfalse
                            Must Supportfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            184. 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
                            186. 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
                            • 188. 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())
                              190. 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
                              Control0..1
                              TypeCodeableConcept
                              Is Modifierfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              192. 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
                              BindingThe codes SHOULD be taken from ISO Country two letter code
                              (preferred to http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country)
                              TypeCodeableConcept
                              Is Modifierfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              194. 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
                              TypeCodeableConcept
                              Is Modifierfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              196. 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()))
                              198. 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()))
                              200. 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.

                              ShortIf the drug product is supplied with another item such as a diluent
                              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 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()))
                              202. PackagedProductDefinition.manufacturer
                              Definition

                              Reference to the manufacturer organization (DEUePIPLOrganization profile).

                              ShortManufacturer
                              Control1..1
                              TypeReference(02 DEU ePIL Organization)
                              Is Modifierfalse
                              Must Supporttrue
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              204. PackagedProductDefinition.attachedDocument
                              Definition

                              Additional information or supporting documentation about the packaged product.

                              ShortAdditional information or supporting documentation about the packaged product
                              Control0..*
                              TypeReference(DocumentReference)
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              206. 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()))
                              208. 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
                              210. 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())
                              212. 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())
                              214. 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)
                              Control1..*
                              TypeIdentifier
                              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.identifier.id
                              Definition

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

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

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

                              ShortAdditional content defined by implementations
                              Comments

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

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

                                The purpose of this identifier.

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

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

                                Control0..1
                                BindingThe codes SHALL be taken from IdentifierUse
                                (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

                                Identifies the purpose for this identifier, if known .

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

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

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

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

                                ShortDescription of identifier
                                Comments

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

                                Control0..1
                                BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
                                (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

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

                                TypeCodeableConcept
                                Is Modifierfalse
                                Summarytrue
                                Requirements

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

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

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

                                ShortThe namespace for the identifier value
                                Comments

                                Identifier.system is always case sensitive.

                                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.

                                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()))
                                226. PackagedProductDefinition.packaging.identifier.value
                                Definition

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

                                ShortThe value that is unique
                                Comments

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

                                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()))
                                228. PackagedProductDefinition.packaging.identifier.period
                                Definition

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

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

                                Organization that issued/manages the identifier.

                                ShortOrganization that issued id (may be just text)
                                Comments

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

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

                                The physical type of the container of the items.

                                ShortThe physical type of the container of the items
                                Control0..1
                                BindingFor example codes, see PackagingType
                                (example to http://hl7.org/fhir/ValueSet/packaging-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()))
                                234. 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()))
                                236. 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()))
                                238. PackagedProductDefinition.packaging.material
                                Definition

                                Material type of the package item.

                                ShortMaterial type of the package item
                                Control0..1
                                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()))
                                240. 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()))
                                242. 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()))
                                244. 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
                                246. 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
                                • 248. 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())
                                  250. 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
                                  Control0..1
                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  252. 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
                                  Control0..1
                                  TypeChoice of: Duration, string
                                  [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
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  SlicingThis element introduces a set of slices on PackagedProductDefinition.packaging.shelfLifeStorage.period[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                  • type @ $this
                                  • 254. PackagedProductDefinition.packaging.shelfLifeStorage.period[x]:periodDuration
                                    Slice NameperiodDuration
                                    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
                                    Control0..1
                                    TypeDuration
                                    [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()))
                                    256. 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..1
                                    TypeCodeableConcept
                                    Is Modifierfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    258. 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 (ePI))
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    260. 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()))
                                    262. 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
                                    264. 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())
                                    266. 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())
                                    268. 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()))
                                    270. 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()))
                                    272. 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()))
                                    274. 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
                                    276. 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())
                                    278. 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())
                                    280. 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(ManufacturedItemDefinition (ePI), DeviceDefinition)
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    282. 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)
                                    Control0..1
                                    TypeQuantity
                                    Is Modifierfalse
                                    Must Supportfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    284. 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()))
                                    286. 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..*
                                    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()))