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 and Regulation. 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
Standards status: Trial-use Active as of 2026-04-03 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.
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... 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. 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.
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... 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
... 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) Pack artwork images or other related documents associated with this package.
... 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
.... 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.

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 0..* PackagedProductDefinition A medically related item or items, in a container or package
... 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.
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... status
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... 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
.... code
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... jurisdiction
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
... marketingStatus
.... country
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... status
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
... 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)
... attachedDocument 0..* Reference(DocumentReference) Pack artwork images or other related documents associated with this package.
... packaging 0..1 BackboneElement A packaging item, as a container for medically related items, possibly with other packaging items within.
.... identifier
..... system 1..1 uri The namespace for the identifier value
..... value 1..1 string The value that is unique
.... type
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... material
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... alternateMaterial
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... shelfLifeStorage
..... type
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
....... code 1..1 code Symbol in syntax defined by the system
....... display 1..1 string Representation defined by the system
..... specialPrecautionsForStorage
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
....... code 1..1 code Symbol in syntax defined by the system
....... display 1..1 string Representation defined by the system
.... property
..... type
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
....... code 1..1 code Symbol in syntax defined by the system
....... display 1..1 string Representation defined by the system
.... 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.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..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
... 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. 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.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..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
... 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. In what situation this package type may be supplied for use
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..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
.... jurisdiction Σ 0..1 CodeableConcept The place where the legal status of supply applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..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
... 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
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..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
.... 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
.... 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
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..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
.... 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 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) Pack artwork images or other related documents associated with this package.
... 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 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.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..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
.... 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.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..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
.... 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.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..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
.... 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
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..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
..... 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
...... periodDuration Duration
...... periodString string
..... specialPrecautionsForStorage Σ 0..* 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
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..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
.... 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.
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..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
..... 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) 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.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​packaging.identifier.​type Base extensible Identifier Type Codes 📍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.
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... 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. 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.
.... coding Σ 1..1 Coding Code defined by a terminology system
..... system Σ 1..1 uri Identity of the terminology system
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..1 string Representation defined by the system
... 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
... 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) Pack artwork images or other related documents associated with this package.
... 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
.... 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.

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 0..* PackagedProductDefinition A medically related item or items, in a container or package
... 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.
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... status
.... coding 1..1 Coding Code defined by a terminology system
..... system 1..1 uri Identity of the terminology system
..... code 1..1 code Symbol in syntax defined by the system
..... display 1..1 string Representation defined by the system
... 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
.... code
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... jurisdiction
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
... marketingStatus
.... country
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... status
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
... 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)
... attachedDocument 0..* Reference(DocumentReference) Pack artwork images or other related documents associated with this package.
... packaging 0..1 BackboneElement A packaging item, as a container for medically related items, possibly with other packaging items within.
.... identifier
..... system 1..1 uri The namespace for the identifier value
..... value 1..1 string The value that is unique
.... type
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... material
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... alternateMaterial
..... coding 1..1 Coding Code defined by a terminology system
...... system 1..1 uri Identity of the terminology system
...... code 1..1 code Symbol in syntax defined by the system
...... display 1..1 string Representation defined by the system
.... shelfLifeStorage
..... type
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
....... code 1..1 code Symbol in syntax defined by the system
....... display 1..1 string Representation defined by the system
..... specialPrecautionsForStorage
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
....... code 1..1 code Symbol in syntax defined by the system
....... display 1..1 string Representation defined by the system
.... property
..... type
...... coding 1..1 Coding Code defined by a terminology system
....... system 1..1 uri Identity of the terminology system
....... code 1..1 code Symbol in syntax defined by the system
....... display 1..1 string Representation defined by the system
.... 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.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..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
... 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. 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.
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ 1..1 Coding Code defined by a terminology system
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code ΣC 1..1 code Symbol in syntax defined by the system
..... display ΣC 1..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
... 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. In what situation this package type may be supplied for use
Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..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
.... jurisdiction Σ 0..1 CodeableConcept The place where the legal status of supply applies
Binding: JurisdictionValueSet (example): Jurisdiction codes
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..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
... 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
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..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
.... 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
.... 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
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..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
.... 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 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) Pack artwork images or other related documents associated with this package.
... 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 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.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..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
.... 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.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..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
.... 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.
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... coding Σ 1..1 Coding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 1..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
.... 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
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..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
..... 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
...... periodDuration Duration
...... periodString string
..... specialPrecautionsForStorage Σ 0..* 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
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..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
.... 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.
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... coding Σ 1..1 Coding Code defined by a terminology system
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... system Σ 1..1 uri Identity of the terminology system
....... version Σ 0..1 string Version of the system - if relevant
....... code ΣC 1..1 code Symbol in syntax defined by the system
....... display ΣC 1..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
..... 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) 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.identifier.​use Base required IdentifierUse 📍5.0.0 FHIR Std.
PackagedProductDefinition.​packaging.identifier.​type Base extensible Identifier Type Codes 📍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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