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

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

Resource Profile: EMA Write API PackagedProductDefinition

Official URL: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiPackagedProductDefinitionRestrictions Version: 1.2.0
Draft as of 2025-08-08 Computable Name: EmaWriteApiPackagedProductDefinitionRestrictions

Defines the restrictive rules a PackagedProductDefinition resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application

Usage:

Formal Views of Profile Content

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

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
... 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.


ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard

This structure is derived from PackagedProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition PackagedProductDefinition
... meta 0..0
... implicitRules 0..0
... language 0..0
... contained 0..0
... extension 0..0
... modifierExtension 0..0
... name 0..0
... type 0..0
... statusDate 0..0
... copackagedIndicator 0..0
... attachedDocument 0..0
... characteristic 0..0

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... id Σ 0..1 id Logical id of this artifact
... identifier Σ 0..* Identifier A unique identifier for this package as whole - not for the content of the package
... packageFor Σ 0..* Reference(MedicinalProductDefinition) The product that this is a pack for
... containedItemQuantity Σ 0..* Quantity A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
... 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
... manufacturer Σ 0..* Reference(Organization) Manufacturer of this package type (multiple means these are all possible manufacturers)
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
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.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
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

This structure is derived from PackagedProductDefinition

Summary

Prohibited: 13 elements

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
... 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.


ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
PackagedProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard

Differential View

This structure is derived from PackagedProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition PackagedProductDefinition
... meta 0..0
... implicitRules 0..0
... language 0..0
... contained 0..0
... extension 0..0
... modifierExtension 0..0
... name 0..0
... type 0..0
... statusDate 0..0
... copackagedIndicator 0..0
... attachedDocument 0..0
... characteristic 0..0

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition A medically related item or items, in a container or package
... id Σ 0..1 id Logical id of this artifact
... identifier Σ 0..* Identifier A unique identifier for this package as whole - not for the content of the package
... packageFor Σ 0..* Reference(MedicinalProductDefinition) The product that this is a pack for
... containedItemQuantity Σ 0..* Quantity A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
... 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
... manufacturer Σ 0..* Reference(Organization) Manufacturer of this package type (multiple means these are all possible manufacturers)
... 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

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
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.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
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

This structure is derived from PackagedProductDefinition

Summary

Prohibited: 13 elements

 

Other representations of profile: CSV, Excel, Schematron