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
Official URL: http://pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEUePIPLPackagedProductDefinition | Version: 0.1.0 | |||
Draft as of 2025-06-13 | Computable Name: DEUePIPLPackagedProductDefinition |
Defines the PackagedProductDefinition resource, including packaging identifiers (GTIN, PZN, ENR_ID), name, and quantity of contained items.
Usages:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
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0..* | PackagedProductDefinitionUvEpi | A medically related item or items, in a container or package | |
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?!Σ | 0..1 | uri | A set of rules under which this content was created |
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0..* | Resource | Contained, inline Resources | |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored |
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Σ | 1..* | Identifier | Sliced to require GTIN, optionally allow PZN and ENR_ID Slice: Unordered, Open by value:type.coding.code |
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Content/Rules for all slices | |||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
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Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
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ΣC | 1..1 | string | The value that is unique Example General: 123456 |
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Σ | 1..1 | Identifier | GTIN (Global Trade Item Number) |
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
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Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: https://gs1.org/gtin |
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ΣC | 1..1 | string | The value that is unique Example General: 123456 |
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Σ | 0..1 | Identifier | Pharmaceutical Central Number (PZN) |
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
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Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://fhir.de/sid/pzn |
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ΣC | 1..1 | string | The value that is unique Example General: 123456 |
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Σ | 0..1 | Identifier | ENR_ID (ENR + Pack Size) |
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
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Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
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ΣC | 1..1 | string | The value that is unique Example General: 123456 |
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SΣ | 1..1 | string | Packaged Product Name |
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SΣ | 1..1 | Reference(03 DEU ePIL Medicinal Product Definition) | Packaged for Medicinal Product |
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?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
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SΣ | 1..* | Quantity | Contained Quantity |
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SΣ | 1..1 | Reference(02 DEU ePIL Organization) | Manufacturer |
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Path | Conformance | ValueSet | URI |
PackagedProductDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier:gtin.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier:pzn.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier:enr-id.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from PackagedProductDefinitionUvEpi
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
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PackagedProductDefinitionUvEpi | |||
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1..* | Identifier | Sliced to require GTIN, optionally allow PZN and ENR_ID Slice: Unordered, Open by value:type.coding.code | |
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1..1 | Identifier | GTIN (Global Trade Item Number) | |
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0..1 | uri | Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/100000000009 | |
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1..1 | code | Symbol in syntax defined by the system Required Pattern: 100000167575 | |
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0..1 | string | Representation defined by the system Required Pattern: GS1 Global Trade Item Number | |
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1..1 | uri | The namespace for the identifier value Required Pattern: https://gs1.org/gtin | |
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0..1 | Identifier | Pharmaceutical Central Number (PZN) | |
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0..1 | uri | Identity of the terminology system Required Pattern: http://fhir.de/CodeSystem/ifa/pzn | |
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1..1 | code | Symbol in syntax defined by the system Required Pattern: PZN | |
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1..1 | uri | The namespace for the identifier value Required Pattern: http://fhir.de/sid/pzn | |
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0..1 | Identifier | ENR_ID (ENR + Pack Size) | |
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1..1 | code | Symbol in syntax defined by the system Required Pattern: ENR_ID | |
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S | 1..1 | string | Packaged Product Name |
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S | 1..1 | Reference(03 DEU ePIL Medicinal Product Definition) | Packaged for Medicinal Product |
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S | 1..* | Quantity | Contained Quantity |
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S | 1..1 | Reference(02 DEU ePIL Organization) | Manufacturer |
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Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
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0..* | PackagedProductDefinitionUvEpi | A medically related item or items, in a container or package | |||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
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0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
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0..* | Resource | Contained, inline Resources | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
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Σ | 1..* | Identifier | Sliced to require GTIN, optionally allow PZN and ENR_ID Slice: Unordered, Open by value:type.coding.code | ||||
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Content/Rules for all slices | |||||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
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Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||||
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Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
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Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
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Σ | 1..1 | Identifier | GTIN (Global Trade Item Number) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
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Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..1 | uri | Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/100000000009 | ||||
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Σ | 0..1 | string | Version of the system - if relevant | ||||
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ΣC | 1..1 | code | Symbol in syntax defined by the system Required Pattern: 100000167575 | ||||
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ΣC | 0..1 | string | Representation defined by the system Required Pattern: GS1 Global Trade Item Number | ||||
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Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: https://gs1.org/gtin | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
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Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
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Σ | 0..1 | Identifier | Pharmaceutical Central Number (PZN) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
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Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..1 | uri | Identity of the terminology system Required Pattern: http://fhir.de/CodeSystem/ifa/pzn | ||||
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Σ | 0..1 | string | Version of the system - if relevant | ||||
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ΣC | 1..1 | code | Symbol in syntax defined by the system Required Pattern: PZN | ||||
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ΣC | 0..1 | string | Representation defined by the system | ||||
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Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://fhir.de/sid/pzn | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
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Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
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Σ | 0..1 | Identifier | ENR_ID (ENR + Pack Size) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
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Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..1 | uri | Identity of the terminology system | ||||
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Σ | 0..1 | string | Version of the system - if relevant | ||||
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ΣC | 1..1 | code | Symbol in syntax defined by the system Required Pattern: ENR_ID | ||||
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ΣC | 0..1 | string | Representation defined by the system | ||||
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Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
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Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
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SΣ | 1..1 | string | Packaged Product Name | ||||
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Σ | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: PackageType (example): A high level categorisation of a package. | ||||
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SΣ | 1..1 | Reference(03 DEU ePIL Medicinal Product Definition) | Packaged for Medicinal Product | ||||
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?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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Σ | 0..1 | dateTime | The date at which the given status became applicable Example Example of a status date: 2015-02-07T13:28:17Z | ||||
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SΣ | 1..* | Quantity | Contained Quantity | ||||
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Σ | 0..1 | markdown | Narrative description of the overall pack; e.g., description of a sample pack | ||||
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Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator. | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product | ||||
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Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: ISO Country two letter code (preferred) | ||||
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Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | CodeableConcept | 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 | ||||
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Σ | 0..1 | CodeableConcept | 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 Binding: ISO Country two letter code (preferred) | ||||
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Σ | 1..1 | CodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples | ||||
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Σ | 0..1 | Period | 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 | ||||
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Σ | 0..1 | dateTime | 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 | ||||
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Σ | 0..1 | boolean | If the drug product is supplied with another item such as a diluent | ||||
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SΣ | 1..1 | Reference(02 DEU ePIL Organization) | Manufacturer | ||||
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Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the packaged product | ||||
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Σ | 0..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
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Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||||
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Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
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Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
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Σ | 0..1 | CodeableConcept | The physical type of the container of the items Binding: PackagingType (example): A high level categorisation of a package. | ||||
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Σ | 0..1 | boolean | 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) | ||||
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Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | ||||
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Σ | 0..1 | CodeableConcept | Material type of the package item Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
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Σ | 0..* | CodeableConcept | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
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Σ | 0..* | ProductShelfLife | Shelf Life and storage information. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | CodeableConcept | 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 | ||||
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Σ | 0..1 | 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 Slice: Unordered, Open by type:$this | |||||
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Duration | |||||||
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string | |||||||
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Σ | 0..1 | Duration | 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 | ||||
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Σ | 0..1 | CodeableConcept | 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 | ||||
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Σ | 0..* | Reference(Organization (ePI)) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | ||||
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Σ | 0..* | BackboneElement | General characteristics of this item | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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Σ | 0..1 | A value for the characteristic | |||||
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CodeableConcept | |||||||
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Quantity | |||||||
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date | |||||||
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boolean | |||||||
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Attachment | |||||||
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Σ | 0..* | BackboneElement | The item(s) within the packaging | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | CodeableReference(ManufacturedItemDefinition (ePI) | DeviceDefinition) | The 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 | ||||
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Σ | 0..1 | Quantity | 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) | ||||
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Σ | 0..* | See packaging (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still as a part of single packaged product | ||||
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Σ | 0..* | See property (PackagedProductDefinition) | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" | ||||
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Path | Conformance | ValueSet | URI |
PackagedProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type From the FHIR Standard | |
PackagedProductDefinition.identifier:gtin.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier:gtin.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type From the FHIR Standard | |
PackagedProductDefinition.identifier:pzn.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier:pzn.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type From the FHIR Standard | |
PackagedProductDefinition.identifier:enr-id.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier:enr-id.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type From the FHIR Standard | |
PackagedProductDefinition.type | example | PackageTypehttp://hl7.org/fhir/ValueSet/package-type From the FHIR Standard | |
PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard | |
PackagedProductDefinition.legalStatusOfSupply.code | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supply From the FHIR Standard | |
PackagedProductDefinition.legalStatusOfSupply.jurisdiction | preferred | VsCountryhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country | |
PackagedProductDefinition.marketingStatus.jurisdiction | preferred | VsCountryhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country | |
PackagedProductDefinition.packaging.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.packaging.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type From the FHIR Standard | |
PackagedProductDefinition.packaging.type | example | PackagingTypehttp://hl7.org/fhir/ValueSet/packaging-type From the FHIR Standard | |
PackagedProductDefinition.packaging.material | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-material From the FHIR Standard | |
PackagedProductDefinition.packaging.alternateMaterial | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-material From the FHIR Standard | |
PackagedProductDefinition.packaging.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from PackagedProductDefinitionUvEpi
Summary
Mandatory: 5 elements(3 nested mandatory elements)
Must-Support: 4 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Key Elements View
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
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0..* | PackagedProductDefinitionUvEpi | A medically related item or items, in a container or package | |
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?!Σ | 0..1 | uri | A set of rules under which this content was created |
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0..* | Resource | Contained, inline Resources | |
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?!Σ | 0..* | Extension | Extensions that cannot be ignored |
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Σ | 1..* | Identifier | Sliced to require GTIN, optionally allow PZN and ENR_ID Slice: Unordered, Open by value:type.coding.code |
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Content/Rules for all slices | |||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
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Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
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ΣC | 1..1 | string | The value that is unique Example General: 123456 |
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Σ | 1..1 | Identifier | GTIN (Global Trade Item Number) |
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
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Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: https://gs1.org/gtin |
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ΣC | 1..1 | string | The value that is unique Example General: 123456 |
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Σ | 0..1 | Identifier | Pharmaceutical Central Number (PZN) |
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
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Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://fhir.de/sid/pzn |
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ΣC | 1..1 | string | The value that is unique Example General: 123456 |
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Σ | 0..1 | Identifier | ENR_ID (ENR + Pack Size) |
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . |
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Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient |
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ΣC | 1..1 | string | The value that is unique Example General: 123456 |
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SΣ | 1..1 | string | Packaged Product Name |
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SΣ | 1..1 | Reference(03 DEU ePIL Medicinal Product Definition) | Packaged for Medicinal Product |
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?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
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SΣ | 1..* | Quantity | Contained Quantity |
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SΣ | 1..1 | Reference(02 DEU ePIL Organization) | Manufacturer |
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Path | Conformance | ValueSet | URI |
PackagedProductDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier:gtin.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier:pzn.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier:enr-id.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Differential View
This structure is derived from PackagedProductDefinitionUvEpi
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() |
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PackagedProductDefinitionUvEpi | |||
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1..* | Identifier | Sliced to require GTIN, optionally allow PZN and ENR_ID Slice: Unordered, Open by value:type.coding.code | |
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1..1 | Identifier | GTIN (Global Trade Item Number) | |
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0..1 | uri | Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/100000000009 | |
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1..1 | code | Symbol in syntax defined by the system Required Pattern: 100000167575 | |
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0..1 | string | Representation defined by the system Required Pattern: GS1 Global Trade Item Number | |
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1..1 | uri | The namespace for the identifier value Required Pattern: https://gs1.org/gtin | |
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0..1 | Identifier | Pharmaceutical Central Number (PZN) | |
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0..1 | uri | Identity of the terminology system Required Pattern: http://fhir.de/CodeSystem/ifa/pzn | |
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1..1 | code | Symbol in syntax defined by the system Required Pattern: PZN | |
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1..1 | uri | The namespace for the identifier value Required Pattern: http://fhir.de/sid/pzn | |
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0..1 | Identifier | ENR_ID (ENR + Pack Size) | |
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1..1 | code | Symbol in syntax defined by the system Required Pattern: ENR_ID | |
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S | 1..1 | string | Packaged Product Name |
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S | 1..1 | Reference(03 DEU ePIL Medicinal Product Definition) | Packaged for Medicinal Product |
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S | 1..* | Quantity | Contained Quantity |
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S | 1..1 | Reference(02 DEU ePIL Organization) | Manufacturer |
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Snapshot View
Name | Flags | Card. | Type | Description & Constraints Filter: ![]() ![]() | ||||
---|---|---|---|---|---|---|---|---|
![]() ![]() |
0..* | PackagedProductDefinitionUvEpi | A medically related item or items, in a container or package | |||||
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Σ | 0..1 | id | Logical id of this artifact | ||||
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Σ | 0..1 | Meta | Metadata about the resource | ||||
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?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
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0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
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0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
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0..* | Resource | Contained, inline Resources | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
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Σ | 1..* | Identifier | Sliced to require GTIN, optionally allow PZN and ENR_ID Slice: Unordered, Open by value:type.coding.code | ||||
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Content/Rules for all slices | |||||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
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Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||||
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Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
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Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
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Σ | 1..1 | Identifier | GTIN (Global Trade Item Number) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
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Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..* | Coding | Code defined by a terminology system | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..1 | uri | Identity of the terminology system Required Pattern: http://ema.europa.eu/fhir/CodeSystem/100000000009 | ||||
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Σ | 0..1 | string | Version of the system - if relevant | ||||
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ΣC | 1..1 | code | Symbol in syntax defined by the system Required Pattern: 100000167575 | ||||
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ΣC | 0..1 | string | Representation defined by the system Required Pattern: GS1 Global Trade Item Number | ||||
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Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: https://gs1.org/gtin | ||||
![]() ![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
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Σ | 0..1 | Identifier | Pharmaceutical Central Number (PZN) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
Σ | 0..* | Coding | Code defined by a terminology system | ||||
![]() ![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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Σ | 0..1 | uri | Identity of the terminology system Required Pattern: http://fhir.de/CodeSystem/ifa/pzn | ||||
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Σ | 0..1 | string | Version of the system - if relevant | ||||
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ΣC | 1..1 | code | Symbol in syntax defined by the system Required Pattern: PZN | ||||
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ΣC | 0..1 | string | Representation defined by the system | ||||
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Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 1..1 | uri | The namespace for the identifier value Required Pattern: http://fhir.de/sid/pzn | ||||
![]() ![]() ![]() ![]() ![]() |
ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
![]() ![]() ![]() ![]() |
Σ | 0..1 | Identifier | ENR_ID (ENR + Pack Size) | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() ![]() ![]() ![]() |
Σ | 0..* | Coding | Code defined by a terminology system | ||||
![]() ![]() ![]() ![]() ![]() ![]() ![]() |
0..1 | id | Unique id for inter-element referencing | |||||
![]() ![]() ![]() ![]() ![]() ![]() ![]() |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
![]() ![]() ![]() ![]() ![]() ![]() ![]() |
Σ | 0..1 | uri | Identity of the terminology system | ||||
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Σ | 0..1 | string | Version of the system - if relevant | ||||
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ΣC | 1..1 | code | Symbol in syntax defined by the system Required Pattern: ENR_ID | ||||
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ΣC | 0..1 | string | Representation defined by the system | ||||
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Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
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Σ | 0..1 | string | Plain text representation of the concept | ||||
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Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
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Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
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SΣ | 1..1 | string | Packaged Product Name | ||||
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Σ | 0..1 | CodeableConcept | A high level category e.g., medicinal product pack, sample pack, shipping container. Binding: PackageType (example): A high level categorisation of a package. | ||||
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SΣ | 1..1 | Reference(03 DEU ePIL Medicinal Product Definition) | Packaged for Medicinal Product | ||||
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?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
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Σ | 0..1 | dateTime | The date at which the given status became applicable Example Example of a status date: 2015-02-07T13:28:17Z | ||||
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SΣ | 1..* | Quantity | Contained Quantity | ||||
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Σ | 0..1 | markdown | Narrative description of the overall pack; e.g., description of a sample pack | ||||
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Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator. | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product | ||||
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Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: ISO Country two letter code (preferred) | ||||
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Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | CodeableConcept | 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 | ||||
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Σ | 0..1 | CodeableConcept | 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 Binding: ISO Country two letter code (preferred) | ||||
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Σ | 1..1 | CodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples | ||||
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Σ | 0..1 | Period | 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 | ||||
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Σ | 0..1 | dateTime | 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 | ||||
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Σ | 0..1 | boolean | If the drug product is supplied with another item such as a diluent | ||||
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SΣ | 1..1 | Reference(02 DEU ePIL Organization) | Manufacturer | ||||
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Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the packaged product | ||||
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Σ | 0..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..1 | code | usual | official | temp | secondary | old (If known) Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known . | ||||
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Σ | 0..1 | CodeableConcept | Description of identifier Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose. | ||||
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Σ | 1..1 | uri | The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient | ||||
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ΣC | 1..1 | string | The value that is unique Example General: 123456 | ||||
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Σ | 0..1 | Period | Time period when id is/was valid for use | ||||
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Σ | 0..1 | Reference(Organization) | Organization that issued id (may be just text) | ||||
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Σ | 0..1 | CodeableConcept | The physical type of the container of the items Binding: PackagingType (example): A high level categorisation of a package. | ||||
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Σ | 0..1 | boolean | 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) | ||||
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Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | ||||
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Σ | 0..1 | CodeableConcept | Material type of the package item Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
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Σ | 0..* | CodeableConcept | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
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Σ | 0..* | ProductShelfLife | Shelf Life and storage information. | ||||
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0..1 | id | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 0..1 | CodeableConcept | 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 | ||||
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Σ | 0..1 | 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 Slice: Unordered, Open by type:$this | |||||
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Duration | |||||||
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string | |||||||
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Σ | 0..1 | Duration | 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 | ||||
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Σ | 0..1 | CodeableConcept | 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 | ||||
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Σ | 0..* | Reference(Organization (ePI)) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | ||||
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Σ | 0..* | BackboneElement | General characteristics of this item | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. | ||||
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Σ | 0..1 | A value for the characteristic | |||||
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CodeableConcept | |||||||
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Quantity | |||||||
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date | |||||||
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boolean | |||||||
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Attachment | |||||||
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Σ | 0..* | BackboneElement | The item(s) within the packaging | ||||
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0..1 | string | Unique id for inter-element referencing | |||||
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0..* | Extension | Additional content defined by implementations | |||||
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?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
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Σ | 1..1 | CodeableReference(ManufacturedItemDefinition (ePI) | DeviceDefinition) | The 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 | ||||
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Σ | 0..1 | Quantity | 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) | ||||
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Σ | 0..* | See packaging (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still as a part of single packaged product | ||||
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Σ | 0..* | See property (PackagedProductDefinition) | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" | ||||
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Path | Conformance | ValueSet | URI |
PackagedProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type From the FHIR Standard | |
PackagedProductDefinition.identifier:gtin.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier:gtin.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type From the FHIR Standard | |
PackagedProductDefinition.identifier:pzn.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier:pzn.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type From the FHIR Standard | |
PackagedProductDefinition.identifier:enr-id.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.identifier:enr-id.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type From the FHIR Standard | |
PackagedProductDefinition.type | example | PackageTypehttp://hl7.org/fhir/ValueSet/package-type From the FHIR Standard | |
PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-status From the FHIR Standard | |
PackagedProductDefinition.legalStatusOfSupply.code | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supply From the FHIR Standard | |
PackagedProductDefinition.legalStatusOfSupply.jurisdiction | preferred | VsCountryhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country | |
PackagedProductDefinition.marketingStatus.jurisdiction | preferred | VsCountryhttp://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country | |
PackagedProductDefinition.packaging.identifier.use | required | IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0 From the FHIR Standard | |
PackagedProductDefinition.packaging.identifier.type | extensible | IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type From the FHIR Standard | |
PackagedProductDefinition.packaging.type | example | PackagingTypehttp://hl7.org/fhir/ValueSet/packaging-type From the FHIR Standard | |
PackagedProductDefinition.packaging.material | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-material From the FHIR Standard | |
PackagedProductDefinition.packaging.alternateMaterial | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-material From the FHIR Standard | |
PackagedProductDefinition.packaging.property.type | example | ProductCharacteristichttp://hl7.org/fhir/ValueSet/product-characteristic-codes From the FHIR Standard |
Id | Grade | Path(s) | Details | Requirements |
dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
dom-3 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | 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 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from PackagedProductDefinitionUvEpi
Summary
Mandatory: 5 elements(3 nested mandatory elements)
Must-Support: 4 elements
Structures
This structure refers to these other structures:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron