German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide
0.7.0 - ci-build

German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide - Local Development build (v0.7.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: 04 - DEU ePIL Packaged Product Definition

Official URL: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-PackagedProductDefinition Version: 0.7.0
Draft as of 2026-05-04 Computable Name: DEU_ePIL_PackagedProductDefinition

Defines the PackagedProductDefinition resource, including optional packaging identifiers (GTIN, NTIN, PPN, PZN, PCID), name, and quantity of contained items.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... id Σ 1..1 id Technical ID of this packaged product
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for identifier Σ 0..* Identifier Package identifiers (all optional)
Slice: Unordered, Open by value:type.coding.system, value:type.coding.code
.... identifier:All Slices Content/Rules for all slices
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
.... identifier:gtin Σ 0..1 Identifier GTIN (Global Trade Item Number) - Optional
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... coding Σ 1..1 Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: 100000167575
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: GS1 Global Trade Item Number
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:ntin Σ 0..1 Identifier NTIN (National Trade Item Number)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... coding Σ 1..1 Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: 200000027030
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: National Trade Item Number
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:ppn Σ 0..1 Identifier PPN (Pharmacy Product Number)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... coding Σ 1..1 Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: 200000027029
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: Pharmacy Product Number
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:pzn Σ 0..1 Identifier PZN (Pharmaceutical Central Number)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:pcid Σ 0..1 Identifier PCID (Packaged Medicinal Product Identifier)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... coding Σ 1..1 Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: PCID
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: Packaged Medicinal Product Identifier
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
... name Σ 0..1 string Package name
... packageFor SΣ 1..1 Reference(03 - DEU ePIL Medicinal Product Definition) Packaged for Medicinal Product
... status ?!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.
... containedItemQuantity SΣ 0..* Quantity Contained Quantity
... manufacturer SΣ 0..1 Reference(02 - DEU ePIL Organization) Manufacturer

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
PackagedProductDefinition.​identifier.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:gtin.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:gtin.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:ntin.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:ntin.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:ppn.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:ppn.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:pzn.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:pcid.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:pcid.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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 PackagedProductDefinition

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition PackagedProductDefinition
... id 1..1 id Technical ID of this packaged product
... Slices for identifier 0..* Identifier Package identifiers (all optional)
Slice: Unordered, Open by value:type.coding.system, value:type.coding.code
.... identifier:All Slices Content/Rules for all slices
..... type 0..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
.... identifier:gtin 0..1 Identifier GTIN (Global Trade Item Number) - Optional
..... type 1..1 CodeableConcept Description of identifier
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code 1..1 code Symbol in syntax defined by the system
Required Pattern: 100000167575
....... display 0..1 string Representation defined by the system
Required Pattern: GS1 Global Trade Item Number
..... system 1..1 uri The namespace for the identifier value
..... value 1..1 string The value that is unique
.... identifier:ntin 0..1 Identifier NTIN (National Trade Item Number)
..... type 1..1 CodeableConcept Description of identifier
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code 1..1 code Symbol in syntax defined by the system
Required Pattern: 200000027030
....... display 0..1 string Representation defined by the system
Required Pattern: National Trade Item Number
..... system 1..1 uri The namespace for the identifier value
..... value 1..1 string The value that is unique
.... identifier:ppn 0..1 Identifier PPN (Pharmacy Product Number)
..... type 1..1 CodeableConcept Description of identifier
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code 1..1 code Symbol in syntax defined by the system
Required Pattern: 200000027029
....... display 0..1 string Representation defined by the system
Required Pattern: Pharmacy Product Number
..... system 1..1 uri The namespace for the identifier value
..... value 1..1 string The value that is unique
.... identifier:pzn 0..1 Identifier PZN (Pharmaceutical Central Number)
..... type
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code 1..1 code Symbol in syntax defined by the system
Required Pattern: PZN
....... display 0..1 string Representation defined by the system
Required Pattern: Pharmazentralnummer
..... system 1..1 uri The namespace for the identifier value
..... value 1..1 string The value that is unique
.... identifier:pcid 0..1 Identifier PCID (Packaged Medicinal Product Identifier)
..... type 1..1 CodeableConcept Description of identifier
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code 1..1 code Symbol in syntax defined by the system
Required Pattern: PCID
....... display 0..1 string Representation defined by the system
Required Pattern: Packaged Medicinal Product Identifier
..... system 1..1 uri The namespace for the identifier value
..... value 1..1 string The value that is unique
... name 0..1 string Package name
... containedItemQuantity S 0..* Quantity Contained Quantity
... manufacturer S 0..1 Reference(02 - DEU ePIL Organization) Manufacturer

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
PackagedProductDefinition.​identifier.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... id Σ 1..1 id Technical ID of this packaged product
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... Slices for identifier Σ 0..* Identifier Package identifiers (all optional)
Slice: Unordered, Open by value:type.coding.system, value:type.coding.code
.... identifier:All Slices Content/Rules for all slices
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
..... system Σ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 0..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:gtin Σ 0..1 Identifier GTIN (Global Trade Item Number) - Optional
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: 100000167575
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: GS1 Global Trade Item Number
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:ntin Σ 0..1 Identifier NTIN (National Trade Item Number)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: 200000027030
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: National Trade Item Number
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:ppn Σ 0..1 Identifier PPN (Pharmacy Product Number)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: 200000027029
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: Pharmacy Product Number
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:pzn Σ 0..1 Identifier PZN (Pharmaceutical Central Number)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: PZN
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: Pharmazentralnummer
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:pcid Σ 0..1 Identifier PCID (Packaged Medicinal Product Identifier)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: PCID
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: Packaged Medicinal Product Identifier
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... name Σ 0..1 string Package name
... type Σ 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping container etc
Binding: PackageType (example): A high level categorisation of a package.
... packageFor SΣ 1..1 Reference(03 - DEU ePIL Medicinal Product Definition) Packaged for Medicinal Product
... status ?!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.
... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... containedItemQuantity SΣ 0..* Quantity Contained Quantity
... description Σ 0..1 markdown Textual description. Note that this is not the name of the package or product
... legalStatusOfSupply Σ 0..* BackboneElement The legal status of supply of the packaged item as classified by the regulator
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code 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
.... jurisdiction Σ 0..1 CodeableConcept The place where the legal status of supply applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
... marketingStatus 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
... copackagedIndicator Σ 0..1 boolean Identifies if the drug product is supplied with another item such as a diluent or adjuvant
... manufacturer SΣ 0..1 Reference(02 - DEU ePIL Organization) Manufacturer
... attachedDocument Σ 0..* Reference(DocumentReference) Additional information or supporting documentation about the packaged product
... packaging 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
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier Σ 0..* Identifier An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
.... type Σ 0..1 CodeableConcept The physical type of the container of the items
Binding: PackagingType (example): A high level categorisation of a package.
.... componentPart 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)
.... quantity Σ 0..1 integer The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
.... material Σ 0..* CodeableConcept Material type of the package item
Binding: PackageMaterial (example): A material used in the construction of packages and their components.
.... alternateMaterial 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.
.... shelfLifeStorage Σ 0..* ProductShelfLife Shelf Life and storage information
.... manufacturer Σ 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... property Σ 0..* BackboneElement General characteristics of this item
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 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.
..... value[x] Σ 0..1 A value for the characteristic
...... valueCodeableConcept CodeableConcept
...... valueQuantity Quantity
...... valueDate date
...... valueBoolean boolean
...... valueAttachment Attachment
.... containedItem Σ 0..* BackboneElement The item(s) within the packaging
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... item Σ 1..1 CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) 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
..... amount 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)
.... packaging Σ 0..* See packaging (PackagedProductDefinition) Allows containers (and parts of containers) within containers, still as a part of single packaged product
... characteristic Σ 0..* See property (PackagedProductDefinition) Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
PackagedProductDefinition.​language Base required All Languages 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:gtin.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:gtin.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:ntin.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:ntin.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:ppn.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:ppn.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:pzn.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:pzn.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:pcid.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:pcid.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​type Base example Package Type 📍5.0.0 FHIR Std.
PackagedProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
PackagedProductDefinition.​legalStatusOfSupply.​code Base example Legal Status Of Supply 📍5.0.0 FHIR Std.
PackagedProductDefinition.​legalStatusOfSupply.​jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
PackagedProductDefinition.​packaging.type Base example Packaging Type 📍5.0.0 FHIR Std.
PackagedProductDefinition.​packaging.material Base example Package Material 📍5.0.0 FHIR Std.
PackagedProductDefinition.​packaging.alternateMaterial Base example Package Material 📍5.0.0 FHIR Std.
PackagedProductDefinition.​packaging.property.type Base example Product Characteristic 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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 PackagedProductDefinition

Summary

Mandatory: 2 elements(29 nested mandatory elements)
Must-Support: 3 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 2 is sliced based on the values of PackagedProductDefinition.identifier

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... id Σ 1..1 id Technical ID of this packaged product
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... Slices for identifier Σ 0..* Identifier Package identifiers (all optional)
Slice: Unordered, Open by value:type.coding.system, value:type.coding.code
.... identifier:All Slices Content/Rules for all slices
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
.... identifier:gtin Σ 0..1 Identifier GTIN (Global Trade Item Number) - Optional
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... coding Σ 1..1 Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: 100000167575
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: GS1 Global Trade Item Number
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:ntin Σ 0..1 Identifier NTIN (National Trade Item Number)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... coding Σ 1..1 Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: 200000027030
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: National Trade Item Number
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:ppn Σ 0..1 Identifier PPN (Pharmacy Product Number)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... coding Σ 1..1 Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: 200000027029
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: Pharmacy Product Number
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:pzn Σ 0..1 Identifier PZN (Pharmaceutical Central Number)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:pcid Σ 0..1 Identifier PCID (Packaged Medicinal Product Identifier)
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... coding Σ 1..1 Coding Code defined by a terminology system
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: PCID
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: Packaged Medicinal Product Identifier
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
... name Σ 0..1 string Package name
... packageFor SΣ 1..1 Reference(03 - DEU ePIL Medicinal Product Definition) Packaged for Medicinal Product
... status ?!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.
... containedItemQuantity SΣ 0..* Quantity Contained Quantity
... manufacturer SΣ 0..1 Reference(02 - DEU ePIL Organization) Manufacturer

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
PackagedProductDefinition.​identifier.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:gtin.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:gtin.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:ntin.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:ntin.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:ppn.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:ppn.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:pzn.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:pcid.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:pcid.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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 PackagedProductDefinition

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition PackagedProductDefinition
... id 1..1 id Technical ID of this packaged product
... Slices for identifier 0..* Identifier Package identifiers (all optional)
Slice: Unordered, Open by value:type.coding.system, value:type.coding.code
.... identifier:All Slices Content/Rules for all slices
..... type 0..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
.... identifier:gtin 0..1 Identifier GTIN (Global Trade Item Number) - Optional
..... type 1..1 CodeableConcept Description of identifier
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code 1..1 code Symbol in syntax defined by the system
Required Pattern: 100000167575
....... display 0..1 string Representation defined by the system
Required Pattern: GS1 Global Trade Item Number
..... system 1..1 uri The namespace for the identifier value
..... value 1..1 string The value that is unique
.... identifier:ntin 0..1 Identifier NTIN (National Trade Item Number)
..... type 1..1 CodeableConcept Description of identifier
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code 1..1 code Symbol in syntax defined by the system
Required Pattern: 200000027030
....... display 0..1 string Representation defined by the system
Required Pattern: National Trade Item Number
..... system 1..1 uri The namespace for the identifier value
..... value 1..1 string The value that is unique
.... identifier:ppn 0..1 Identifier PPN (Pharmacy Product Number)
..... type 1..1 CodeableConcept Description of identifier
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code 1..1 code Symbol in syntax defined by the system
Required Pattern: 200000027029
....... display 0..1 string Representation defined by the system
Required Pattern: Pharmacy Product Number
..... system 1..1 uri The namespace for the identifier value
..... value 1..1 string The value that is unique
.... identifier:pzn 0..1 Identifier PZN (Pharmaceutical Central Number)
..... type
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code 1..1 code Symbol in syntax defined by the system
Required Pattern: PZN
....... display 0..1 string Representation defined by the system
Required Pattern: Pharmazentralnummer
..... system 1..1 uri The namespace for the identifier value
..... value 1..1 string The value that is unique
.... identifier:pcid 0..1 Identifier PCID (Packaged Medicinal Product Identifier)
..... type 1..1 CodeableConcept Description of identifier
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... code 1..1 code Symbol in syntax defined by the system
Required Pattern: PCID
....... display 0..1 string Representation defined by the system
Required Pattern: Packaged Medicinal Product Identifier
..... system 1..1 uri The namespace for the identifier value
..... value 1..1 string The value that is unique
... name 0..1 string Package name
... containedItemQuantity S 0..* Quantity Contained Quantity
... manufacturer S 0..1 Reference(02 - DEU ePIL Organization) Manufacturer

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
PackagedProductDefinition.​identifier.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... id Σ 1..1 id Technical ID of this packaged product
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... Slices for identifier Σ 0..* Identifier Package identifiers (all optional)
Slice: Unordered, Open by value:type.coding.system, value:type.coding.code
.... identifier:All Slices Content/Rules for all slices
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
..... system Σ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 0..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:gtin Σ 0..1 Identifier GTIN (Global Trade Item Number) - Optional
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: 100000167575
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: GS1 Global Trade Item Number
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:ntin Σ 0..1 Identifier NTIN (National Trade Item Number)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: 200000027030
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: National Trade Item Number
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:ppn Σ 0..1 Identifier PPN (Pharmacy Product Number)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: 200000027029
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: Pharmacy Product Number
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:pzn Σ 0..1 Identifier PZN (Pharmaceutical Central Number)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 0..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: PZN
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: Pharmazentralnummer
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
.... identifier:pcid Σ 0..1 Identifier PCID (Packaged Medicinal Product Identifier)
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .
..... type Σ 1..1 CodeableConcept Description of identifier
Binding: DEU ePIL Identifier Type ValueSet (extensible)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://fhir.pharmaprotect.de/digital/epil-fhir-ig/CodeSystem/DEU-ePIL-Package-IdentifierType
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
Required Pattern: PCID
....... display ΣC 0..1 string Representation defined by the system
Required Pattern: Packaged Medicinal Product Identifier
....... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
...... text Σ 0..1 string Plain text representation of the concept
..... system Σ 1..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 1..1 string The value that is unique
Example General: 123456
..... period Σ 0..1 Period Time period when id is/was valid for use
..... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
... name Σ 0..1 string Package name
... type Σ 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping container etc
Binding: PackageType (example): A high level categorisation of a package.
... packageFor SΣ 1..1 Reference(03 - DEU ePIL Medicinal Product Definition) Packaged for Medicinal Product
... status ?!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.
... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... containedItemQuantity SΣ 0..* Quantity Contained Quantity
... description Σ 0..1 markdown Textual description. Note that this is not the name of the package or product
... legalStatusOfSupply Σ 0..* BackboneElement The legal status of supply of the packaged item as classified by the regulator
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code 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
.... jurisdiction Σ 0..1 CodeableConcept The place where the legal status of supply applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
... marketingStatus 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
... copackagedIndicator Σ 0..1 boolean Identifies if the drug product is supplied with another item such as a diluent or adjuvant
... manufacturer SΣ 0..1 Reference(02 - DEU ePIL Organization) Manufacturer
... attachedDocument Σ 0..* Reference(DocumentReference) Additional information or supporting documentation about the packaged product
... packaging 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
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier Σ 0..* Identifier An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
.... type Σ 0..1 CodeableConcept The physical type of the container of the items
Binding: PackagingType (example): A high level categorisation of a package.
.... componentPart 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)
.... quantity Σ 0..1 integer The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
.... material Σ 0..* CodeableConcept Material type of the package item
Binding: PackageMaterial (example): A material used in the construction of packages and their components.
.... alternateMaterial 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.
.... shelfLifeStorage Σ 0..* ProductShelfLife Shelf Life and storage information
.... manufacturer Σ 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... property Σ 0..* BackboneElement General characteristics of this item
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 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.
..... value[x] Σ 0..1 A value for the characteristic
...... valueCodeableConcept CodeableConcept
...... valueQuantity Quantity
...... valueDate date
...... valueBoolean boolean
...... valueAttachment Attachment
.... containedItem Σ 0..* BackboneElement The item(s) within the packaging
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... item Σ 1..1 CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) 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
..... amount 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)
.... packaging Σ 0..* See packaging (PackagedProductDefinition) Allows containers (and parts of containers) within containers, still as a part of single packaged product
... characteristic Σ 0..* See property (PackagedProductDefinition) Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
PackagedProductDefinition.​language Base required All Languages 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:gtin.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:gtin.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:ntin.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:ntin.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:ppn.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:ppn.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:pzn.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:pzn.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​identifier:pcid.use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​identifier:pcid.type Base extensible DEU ePIL Identifier Type ValueSet 📦0.7.0 This IG
PackagedProductDefinition.​type Base example Package Type 📍5.0.0 FHIR Std.
PackagedProductDefinition.​status Base preferred PublicationStatus 📍5.0.0 FHIR Std.
PackagedProductDefinition.​legalStatusOfSupply.​code Base example Legal Status Of Supply 📍5.0.0 FHIR Std.
PackagedProductDefinition.​legalStatusOfSupply.​jurisdiction Base example Jurisdiction ValueSet 📍5.0.0 FHIR Std.
PackagedProductDefinition.​packaging.type Base example Packaging Type 📍5.0.0 FHIR Std.
PackagedProductDefinition.​packaging.material Base example Package Material 📍5.0.0 FHIR Std.
PackagedProductDefinition.​packaging.alternateMaterial Base example Package Material 📍5.0.0 FHIR Std.
PackagedProductDefinition.​packaging.property.type Base example Product Characteristic 📍5.0.0 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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 PackagedProductDefinition

Summary

Mandatory: 2 elements(29 nested mandatory elements)
Must-Support: 3 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 2 is sliced based on the values of PackagedProductDefinition.identifier

 

Other representations of profile: CSV, Excel, Schematron