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

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

Resource Profile: 04 DEU ePIL Packaged Product Definition

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:

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition 0..* PackagedProductDefinitionUvEpi A medically related item or items, in a container or package
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
.... 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 .
..... 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:gtin Σ 1..1 Identifier GTIN (Global 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 .
..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: https://gs1.org/gtin
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:pzn Σ 0..1 Identifier Pharmaceutical Central Number (PZN)
..... 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
Required Pattern: http://fhir.de/sid/pzn
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:enr-id Σ 0..1 Identifier ENR_ID (ENR + Pack Size)
..... 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
... name SΣ 1..1 string Packaged Product 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 1..* Quantity Contained Quantity
... manufacturer SΣ 1..1 Reference(02 DEU ePIL Organization) Manufacturer

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier:gtin.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier:pzn.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier:enr-id.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorPackagedProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorPackagedProductDefinitionIf 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-4errorPackagedProductDefinitionIf 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-5errorPackagedProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practicePackagedProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from PackagedProductDefinitionUvEpi

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition PackagedProductDefinitionUvEpi
... Slices for identifier 1..* Identifier Sliced to require GTIN, optionally allow PZN and ENR_ID
Slice: Unordered, Open by value:type.coding.code
.... identifier:gtin 1..1 Identifier GTIN (Global Trade Item Number)
..... type
...... coding
....... system 0..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/100000000009
....... 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
Required Pattern: https://gs1.org/gtin
.... identifier:pzn 0..1 Identifier Pharmaceutical Central Number (PZN)
..... type
...... coding
....... system 0..1 uri Identity of the terminology system
Required Pattern: http://fhir.de/CodeSystem/ifa/pzn
....... code 1..1 code Symbol in syntax defined by the system
Required Pattern: PZN
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://fhir.de/sid/pzn
.... identifier:enr-id 0..1 Identifier ENR_ID (ENR + Pack Size)
..... type
...... coding
....... code 1..1 code Symbol in syntax defined by the system
Required Pattern: ENR_ID
... name S 1..1 string Packaged Product Name
... packageFor S 1..1 Reference(03 DEU ePIL Medicinal Product Definition) Packaged for Medicinal Product
... manufacturer S 1..1 Reference(02 DEU ePIL Organization) Manufacturer

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition 0..* PackagedProductDefinitionUvEpi A medically related item or items, in a container or package
... id Σ 0..1 id Logical id of this artifact
... 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
... 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 1..* Identifier Sliced to require GTIN, optionally allow PZN and ENR_ID
Slice: Unordered, Open by 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: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... 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:gtin Σ 1..1 Identifier GTIN (Global 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 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.
...... 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 0..* 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 0..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/100000000009
....... 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
Required Pattern: https://gs1.org/gtin
..... 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 Pharmaceutical Central Number (PZN)
..... 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: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
...... 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 0..* 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 0..1 uri Identity of the terminology system
Required Pattern: http://fhir.de/CodeSystem/ifa/pzn
....... 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
....... 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
Required Pattern: http://fhir.de/sid/pzn
..... 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:enr-id Σ 0..1 Identifier ENR_ID (ENR + Pack Size)
..... 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: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
...... 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 0..* 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 0..1 uri Identity of the terminology system
....... 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: ENR_ID
....... display ΣC 0..1 string Representation defined by the system
....... 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 SΣ 1..1 string Packaged Product Name
... type 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.
... 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
Example Example of a status date: 2015-02-07T13:28:17Z
... containedItemQuantity SΣ 1..* Quantity Contained Quantity
... description Σ 0..1 markdown Narrative description of the overall pack; e.g., description of a sample pack
... 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: ISO Country two letter code (preferred)
... 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.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... country 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
.... jurisdiction 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)
.... status 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
.... dateRange 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
.... restoreDate 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
... copackagedIndicator Σ 0..1 boolean If the drug product is supplied with another item such as a diluent
... manufacturer SΣ 1..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 1..* Identifier An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier 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 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.
..... 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)
.... 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..1 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.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 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
..... Slices for period[x] 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
...... periodDuration Duration
...... periodString string
...... period[x]:periodDuration 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
..... specialPrecautionsForStorage 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
.... manufacturer Σ 0..* Reference(Organization (ePI)) 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 (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
..... 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

PathConformanceValueSetURI
PackagedProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
From the FHIR Standard
PackagedProductDefinition.identifier:gtin.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier:gtin.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
From the FHIR Standard
PackagedProductDefinition.identifier:pzn.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier:pzn.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
From the FHIR Standard
PackagedProductDefinition.identifier:enr-id.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier:enr-id.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
From the FHIR Standard
PackagedProductDefinition.typeexamplePackageType
http://hl7.org/fhir/ValueSet/package-type
From the FHIR Standard
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
From the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.codeexampleLegalStatusOfSupply
http://hl7.org/fhir/ValueSet/legal-status-of-supply
From the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.jurisdictionpreferredVsCountry
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country
PackagedProductDefinition.marketingStatus.jurisdictionpreferredVsCountry
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country
PackagedProductDefinition.packaging.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.packaging.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
From the FHIR Standard
PackagedProductDefinition.packaging.typeexamplePackagingType
http://hl7.org/fhir/ValueSet/packaging-type
From the FHIR Standard
PackagedProductDefinition.packaging.materialexamplePackageMaterial
http://hl7.org/fhir/ValueSet/package-material
From the FHIR Standard
PackagedProductDefinition.packaging.alternateMaterialexamplePackageMaterial
http://hl7.org/fhir/ValueSet/package-material
From the FHIR Standard
PackagedProductDefinition.packaging.property.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorPackagedProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorPackagedProductDefinitionIf 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-4errorPackagedProductDefinitionIf 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-5errorPackagedProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practicePackagedProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust 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:

  • The element 1 is sliced based on the value of PackagedProductDefinition.identifier

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition 0..* PackagedProductDefinitionUvEpi A medically related item or items, in a container or package
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
.... 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 .
..... 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:gtin Σ 1..1 Identifier GTIN (Global 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 .
..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: https://gs1.org/gtin
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:pzn Σ 0..1 Identifier Pharmaceutical Central Number (PZN)
..... 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
Required Pattern: http://fhir.de/sid/pzn
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:enr-id Σ 0..1 Identifier ENR_ID (ENR + Pack Size)
..... 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
... name SΣ 1..1 string Packaged Product 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 1..* Quantity Contained Quantity
... manufacturer SΣ 1..1 Reference(02 DEU ePIL Organization) Manufacturer

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier:gtin.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier:pzn.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier:enr-id.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorPackagedProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorPackagedProductDefinitionIf 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-4errorPackagedProductDefinitionIf 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-5errorPackagedProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practicePackagedProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Differential View

This structure is derived from PackagedProductDefinitionUvEpi

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition PackagedProductDefinitionUvEpi
... Slices for identifier 1..* Identifier Sliced to require GTIN, optionally allow PZN and ENR_ID
Slice: Unordered, Open by value:type.coding.code
.... identifier:gtin 1..1 Identifier GTIN (Global Trade Item Number)
..... type
...... coding
....... system 0..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/100000000009
....... 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
Required Pattern: https://gs1.org/gtin
.... identifier:pzn 0..1 Identifier Pharmaceutical Central Number (PZN)
..... type
...... coding
....... system 0..1 uri Identity of the terminology system
Required Pattern: http://fhir.de/CodeSystem/ifa/pzn
....... code 1..1 code Symbol in syntax defined by the system
Required Pattern: PZN
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://fhir.de/sid/pzn
.... identifier:enr-id 0..1 Identifier ENR_ID (ENR + Pack Size)
..... type
...... coding
....... code 1..1 code Symbol in syntax defined by the system
Required Pattern: ENR_ID
... name S 1..1 string Packaged Product Name
... packageFor S 1..1 Reference(03 DEU ePIL Medicinal Product Definition) Packaged for Medicinal Product
... manufacturer S 1..1 Reference(02 DEU ePIL Organization) Manufacturer

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition 0..* PackagedProductDefinitionUvEpi A medically related item or items, in a container or package
... id Σ 0..1 id Logical id of this artifact
... 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
... 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 1..* Identifier Sliced to require GTIN, optionally allow PZN and ENR_ID
Slice: Unordered, Open by 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: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
..... 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:gtin Σ 1..1 Identifier GTIN (Global 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 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.
...... 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 0..* 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 0..1 uri Identity of the terminology system
Required Pattern: http://ema.europa.eu/fhir/CodeSystem/100000000009
....... 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
Required Pattern: https://gs1.org/gtin
..... 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 Pharmaceutical Central Number (PZN)
..... 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: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
...... 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 0..* 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 0..1 uri Identity of the terminology system
Required Pattern: http://fhir.de/CodeSystem/ifa/pzn
....... 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
....... 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
Required Pattern: http://fhir.de/sid/pzn
..... 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:enr-id Σ 0..1 Identifier ENR_ID (ENR + Pack Size)
..... 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: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
...... 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 0..* 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 0..1 uri Identity of the terminology system
....... 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: ENR_ID
....... display ΣC 0..1 string Representation defined by the system
....... 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 SΣ 1..1 string Packaged Product Name
... type 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.
... 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
Example Example of a status date: 2015-02-07T13:28:17Z
... containedItemQuantity SΣ 1..* Quantity Contained Quantity
... description Σ 0..1 markdown Narrative description of the overall pack; e.g., description of a sample pack
... 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: ISO Country two letter code (preferred)
... 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.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... country 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
.... jurisdiction 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)
.... status 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
.... dateRange 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
.... restoreDate 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
... copackagedIndicator Σ 0..1 boolean If the drug product is supplied with another item such as a diluent
... manufacturer SΣ 1..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 1..* Identifier An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier 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 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.
..... 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)
.... 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..1 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.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type 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
..... Slices for period[x] 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
...... periodDuration Duration
...... periodString string
...... period[x]:periodDuration 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
..... specialPrecautionsForStorage 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
.... manufacturer Σ 0..* Reference(Organization (ePI)) 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 (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
..... 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

PathConformanceValueSetURI
PackagedProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
From the FHIR Standard
PackagedProductDefinition.identifier:gtin.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier:gtin.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
From the FHIR Standard
PackagedProductDefinition.identifier:pzn.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier:pzn.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
From the FHIR Standard
PackagedProductDefinition.identifier:enr-id.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.identifier:enr-id.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
From the FHIR Standard
PackagedProductDefinition.typeexamplePackageType
http://hl7.org/fhir/ValueSet/package-type
From the FHIR Standard
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
From the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.codeexampleLegalStatusOfSupply
http://hl7.org/fhir/ValueSet/legal-status-of-supply
From the FHIR Standard
PackagedProductDefinition.legalStatusOfSupply.jurisdictionpreferredVsCountry
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country
PackagedProductDefinition.marketingStatus.jurisdictionpreferredVsCountry
http://hl7.org/fhir/uv/emedicinal-product-info/ValueSet/country
PackagedProductDefinition.packaging.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
From the FHIR Standard
PackagedProductDefinition.packaging.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
From the FHIR Standard
PackagedProductDefinition.packaging.typeexamplePackagingType
http://hl7.org/fhir/ValueSet/packaging-type
From the FHIR Standard
PackagedProductDefinition.packaging.materialexamplePackageMaterial
http://hl7.org/fhir/ValueSet/package-material
From the FHIR Standard
PackagedProductDefinition.packaging.alternateMaterialexamplePackageMaterial
http://hl7.org/fhir/ValueSet/package-material
From the FHIR Standard
PackagedProductDefinition.packaging.property.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
From the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorPackagedProductDefinitionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorPackagedProductDefinitionIf 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-4errorPackagedProductDefinitionIf 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-5errorPackagedProductDefinitionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practicePackagedProductDefinitionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust 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:

  • The element 1 is sliced based on the value of PackagedProductDefinition.identifier

 

Other representations of profile: CSV, Excel, Schematron