Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

Resource Profile: PackagedProductDefinition (ePI)

Official URL: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi Version: 1.1.0
Computable Name: PackagedProductDefinitionUvEpi

PackagedProductDefinition (ePI)

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition 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
.... 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 Σ 0..1 string A name for this package.
... 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 Σ 0..* Reference(MedicinalProductDefinition (ePI)) The product that this is a pack for
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this item.
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
... statusDate Σ 0..1 dateTime The date at which the given status became applicable.
... containedItemQuantity Σ 0..* Quantity A count of the contained items.
... 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.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 0..1 CodeableConcept The actual status of supply.
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...
... copackagedIndicator Σ 0..1 boolean If the drug product is supplied with another item such as a diluent or adjuvant.
... manufacturer Σ 0..* Reference(Organization (ePI)) 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.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier Σ 0..* Identifier Business Identifier for this package.
.... type Σ 0..1 CodeableConcept Type of container.
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.
.... quantity Σ 0..1 integer The quantity of this package in the packaged product.
.... 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 the packaging.
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 (ePI)) Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... property Σ 0..* BackboneElement General characteristics of this item.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type Σ 1..1 CodeableConcept Code that specifies the type of characteristic property.
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 Value of the characteristic.
...... valueCodeableConcept CodeableConcept
...... valueQuantity Quantity
...... valueDate date
...... valueBoolean boolean
...... valueAttachment Attachment
.... containedItem Σ 0..* BackboneElement The item(s) within the packaging.
..... 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.
..... amount Σ 0..1 Quantity The number of this type of item within this packaging.
.... packaging Σ 0..* See packaging (PackagedProductDefinition) Nested packaging.

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.​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()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition PackagedProductDefinition
... identifier 1..* Identifier A unique identifier for this package as whole - not for the content of the package
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... name 0..1 string A name for this package.
... type 0..1 CodeableConcept A high level category e.g., medicinal product pack, sample pack, shipping container.
... status 0..1 CodeableConcept The status within the lifecycle of this item.
... statusDate 0..1 dateTime The date at which the given status became applicable.
... containedItemQuantity 0..* Quantity A count of the contained items.
... description 0..1 markdown Narrative description of the overall pack; e.g., description of a sample pack
... legalStatusOfSupply 0..* BackboneElement The legal status of supply of the packaged item as classified by the regulator.
.... code 0..1 CodeableConcept The actual status of supply.
.... jurisdiction 0..1 CodeableConcept The place where the legal status of supply applies.
... marketingStatus 0..* MarketingStatus Allows specifying that an item is on the market for sale, or that it is not available...
... copackagedIndicator 0..1 boolean If the drug product is supplied with another item such as a diluent or adjuvant.
... manufacturer 0..* Reference(Organization (ePI)) Manufacturer of this package type (multiple means these are all possible manufacturers)
... packaging 0..1 BackboneElement A packaging item, as a container for medically related items, possibly with other packaging items within.
.... identifier 0..* Identifier Business Identifier for this package.
.... type 0..1 CodeableConcept Type of container.
.... componentPart 0..1 boolean Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself.
.... quantity 0..1 integer The quantity of this package in the packaged product.
.... material 0..* CodeableConcept Material type of the package item.
.... alternateMaterial 0..* CodeableConcept A possible alternate material for the packaging.
.... shelfLifeStorage 0..* ProductShelfLife Shelf Life and storage information.
.... manufacturer 0..* Reference(Organization (ePI)) Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... property 0..* BackboneElement General characteristics of this item.
..... type 1..1 CodeableConcept Code that specifies the type of characteristic property.
..... value[x] 0..1 CodeableConcept, Quantity, date, boolean, Attachment Value of the characteristic.
.... containedItem 0..* BackboneElement The item(s) within the packaging.
..... item 1..1 CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) The actual item(s) of medication, as manufactured, or a device, or other medically related item.
..... amount 0..1 Quantity The number of this type of item within this packaging.
.... packaging 0..* Nested packaging.

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition 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
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
... identifier Σ 1..* Identifier A unique identifier for this package as whole - not for the content of the package
.... 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)
... name Σ 0..1 string A name for this package.
... 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 Σ 0..* Reference(MedicinalProductDefinition (ePI)) The product that this is a pack for
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this item.
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
... statusDate Σ 0..1 dateTime The date at which the given status became applicable.
... containedItemQuantity Σ 0..* Quantity A count of the contained items.
... 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.
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...
... copackagedIndicator Σ 0..1 boolean If the drug product is supplied with another item such as a diluent or adjuvant.
... manufacturer Σ 0..* Reference(Organization (ePI)) Manufacturer of this package type (multiple means these are all possible manufacturers)
... 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.
.... 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 Business Identifier for this package.
.... type Σ 0..1 CodeableConcept Type of container.
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.
.... quantity Σ 0..1 integer The quantity of this package in the packaged product.
.... 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 the packaging.
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 (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 Code that specifies the type of characteristic property.
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 Value of 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.
..... amount Σ 0..1 Quantity The number of this type of item within this packaging.
.... packaging Σ 0..* See packaging (PackagedProductDefinition) Nested packaging.
... 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 Identifier Type Codes 📍5.0.0 FHIR Std.
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()

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition 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
.... 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 Σ 0..1 string A name for this package.
... 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 Σ 0..* Reference(MedicinalProductDefinition (ePI)) The product that this is a pack for
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this item.
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
... statusDate Σ 0..1 dateTime The date at which the given status became applicable.
... containedItemQuantity Σ 0..* Quantity A count of the contained items.
... 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.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... code Σ 0..1 CodeableConcept The actual status of supply.
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...
... copackagedIndicator Σ 0..1 boolean If the drug product is supplied with another item such as a diluent or adjuvant.
... manufacturer Σ 0..* Reference(Organization (ePI)) 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.
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... identifier Σ 0..* Identifier Business Identifier for this package.
.... type Σ 0..1 CodeableConcept Type of container.
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.
.... quantity Σ 0..1 integer The quantity of this package in the packaged product.
.... 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 the packaging.
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 (ePI)) Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... property Σ 0..* BackboneElement General characteristics of this item.
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... type Σ 1..1 CodeableConcept Code that specifies the type of characteristic property.
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 Value of the characteristic.
...... valueCodeableConcept CodeableConcept
...... valueQuantity Quantity
...... valueDate date
...... valueBoolean boolean
...... valueAttachment Attachment
.... containedItem Σ 0..* BackboneElement The item(s) within the packaging.
..... 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.
..... amount Σ 0..1 Quantity The number of this type of item within this packaging.
.... packaging Σ 0..* See packaging (PackagedProductDefinition) Nested packaging.

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.​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()

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition PackagedProductDefinition
... identifier 1..* Identifier A unique identifier for this package as whole - not for the content of the package
.... system 1..1 uri The namespace for the identifier value
.... value 1..1 string The value that is unique
... name 0..1 string A name for this package.
... type 0..1 CodeableConcept A high level category e.g., medicinal product pack, sample pack, shipping container.
... status 0..1 CodeableConcept The status within the lifecycle of this item.
... statusDate 0..1 dateTime The date at which the given status became applicable.
... containedItemQuantity 0..* Quantity A count of the contained items.
... description 0..1 markdown Narrative description of the overall pack; e.g., description of a sample pack
... legalStatusOfSupply 0..* BackboneElement The legal status of supply of the packaged item as classified by the regulator.
.... code 0..1 CodeableConcept The actual status of supply.
.... jurisdiction 0..1 CodeableConcept The place where the legal status of supply applies.
... marketingStatus 0..* MarketingStatus Allows specifying that an item is on the market for sale, or that it is not available...
... copackagedIndicator 0..1 boolean If the drug product is supplied with another item such as a diluent or adjuvant.
... manufacturer 0..* Reference(Organization (ePI)) Manufacturer of this package type (multiple means these are all possible manufacturers)
... packaging 0..1 BackboneElement A packaging item, as a container for medically related items, possibly with other packaging items within.
.... identifier 0..* Identifier Business Identifier for this package.
.... type 0..1 CodeableConcept Type of container.
.... componentPart 0..1 boolean Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself.
.... quantity 0..1 integer The quantity of this package in the packaged product.
.... material 0..* CodeableConcept Material type of the package item.
.... alternateMaterial 0..* CodeableConcept A possible alternate material for the packaging.
.... shelfLifeStorage 0..* ProductShelfLife Shelf Life and storage information.
.... manufacturer 0..* Reference(Organization (ePI)) Manufacturer of this packaging item (multiple means these are all potential manufacturers)
.... property 0..* BackboneElement General characteristics of this item.
..... type 1..1 CodeableConcept Code that specifies the type of characteristic property.
..... value[x] 0..1 CodeableConcept, Quantity, date, boolean, Attachment Value of the characteristic.
.... containedItem 0..* BackboneElement The item(s) within the packaging.
..... item 1..1 CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) The actual item(s) of medication, as manufactured, or a device, or other medically related item.
..... amount 0..1 Quantity The number of this type of item within this packaging.
.... packaging 0..* Nested packaging.

doco Documentation for this format

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. PackagedProductDefinition 0..* PackagedProductDefinition 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
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
... identifier Σ 1..* Identifier A unique identifier for this package as whole - not for the content of the package
.... 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)
... name Σ 0..1 string A name for this package.
... 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 Σ 0..* Reference(MedicinalProductDefinition (ePI)) The product that this is a pack for
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this item.
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.
... statusDate Σ 0..1 dateTime The date at which the given status became applicable.
... containedItemQuantity Σ 0..* Quantity A count of the contained items.
... 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.
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...
... copackagedIndicator Σ 0..1 boolean If the drug product is supplied with another item such as a diluent or adjuvant.
... manufacturer Σ 0..* Reference(Organization (ePI)) Manufacturer of this package type (multiple means these are all possible manufacturers)
... 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.
.... 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 Business Identifier for this package.
.... type Σ 0..1 CodeableConcept Type of container.
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.
.... quantity Σ 0..1 integer The quantity of this package in the packaged product.
.... 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 the packaging.
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 (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 Code that specifies the type of characteristic property.
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 Value of 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.
..... amount Σ 0..1 Quantity The number of this type of item within this packaging.
.... packaging Σ 0..* See packaging (PackagedProductDefinition) Nested packaging.
... 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 Identifier Type Codes 📍5.0.0 FHIR Std.
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()

 

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