PackagedProductDefinition

Release 5 Preview #2

This page is part of the FHIR Specification (v4.4.0: R5 Preview #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

11.12.6 Resource PackagedProductDefinition - Detailed Descriptions

Biomedical Research and Regulation

Work Group

Maturity Level: 1

Trial Use

Security Category: Anonymous

Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the PackagedProductDefinition resource.

PackagedProductDefinition
Element Id	PackagedProductDefinition
Definition	A medicinal product in a container or package.
Cardinality	0..*
Type	DomainResource
Summary	true
PackagedProductDefinition.identifier
Element Id	PackagedProductDefinition.identifier
Definition	Unique identifier.
Note	This is a business identifier, not a resource identifier (see discussion)
Cardinality	0..*
Type	Identifier
Summary	true
PackagedProductDefinition.name
Element Id	PackagedProductDefinition.name
Definition	A name for this product pack. Typically what it would be listed as in a drug formulary.
Cardinality	0..1
Type	string
Summary	true
PackagedProductDefinition.subject
Element Id	PackagedProductDefinition.subject
Definition	The product that this is a pack for.
Cardinality	0..*
Type	Reference(MedicinalProductDefinition)
Summary	true
PackagedProductDefinition.status
Element Id	PackagedProductDefinition.status
Definition	The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization or marketing status.
Cardinality	0..1
Terminology Binding	PublicationStatus (Preferred)
Type	CodeableConcept
Summary	true
PackagedProductDefinition.statusDate
Element Id	PackagedProductDefinition.statusDate
Definition	The date at which the given status became applicable.
Cardinality	0..1
Type	dateTime
Summary	true
PackagedProductDefinition.description
Element Id	PackagedProductDefinition.description
Definition	Textual description. Note that this is not the name of the product.
Cardinality	0..1
Type	markdown
Summary	true
PackagedProductDefinition.legalStatusOfSupply
Element Id	PackagedProductDefinition.legalStatusOfSupply
Definition	The legal status of supply of the medicinal product as classified by the regulator.
Cardinality	0..1
Type	CodeableConcept
Summary	true
PackagedProductDefinition.marketingStatus
Element Id	PackagedProductDefinition.marketingStatus
Definition	Marketing information.
Cardinality	0..*
Type	MarketingStatus
Summary	true
PackagedProductDefinition.characteristic
Element Id	PackagedProductDefinition.characteristic
Definition	Allows the key product features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack".
Cardinality	0..*
Type	CodeableConcept
Summary	true
PackagedProductDefinition.copackagedIndicator
Element Id	PackagedProductDefinition.copackagedIndicator
Definition	States whether a drug product is supplied with another item such as a diluent or adjuvant.
Cardinality	0..1
Type	boolean
Summary	true
PackagedProductDefinition.marketingAuthorization
Element Id	PackagedProductDefinition.marketingAuthorization
Definition	Manufacturer of this Package Item.
Cardinality	0..1
Type	Reference(RegulatedAuthorization)
Summary	true
PackagedProductDefinition.manufacturer
Element Id	PackagedProductDefinition.manufacturer
Definition	Manufacturer of this Package Item.
Cardinality	0..*
Type	Reference(Organization)
Summary	true
PackagedProductDefinition.batchIdentifier
Element Id	PackagedProductDefinition.batchIdentifier
Definition	Batch numbering.
Cardinality	0..*
Summary	true
PackagedProductDefinition.batchIdentifier.outerPackaging
Element Id	PackagedProductDefinition.batchIdentifier.outerPackaging
Definition	A number appearing on the outer packaging of a specific batch.
Cardinality	1..1
Type	Identifier
Summary	true
PackagedProductDefinition.batchIdentifier.immediatePackaging
Element Id	PackagedProductDefinition.batchIdentifier.immediatePackaging
Definition	A number appearing on the immediate packaging (and not the outer packaging).
Cardinality	0..1
Type	Identifier
Summary	true
PackagedProductDefinition.package
Element Id	PackagedProductDefinition.package
Definition	A packaging item, as a contained for medicine, possibly with other packaging items within.
Cardinality	0..*
Summary	true
PackagedProductDefinition.package.identifier
Element Id	PackagedProductDefinition.package.identifier
Definition	Including possibly Data Carrier Identifier.
Note	This is a business identifier, not a resource identifier (see discussion)
Cardinality	0..*
Type	Identifier
Summary	true
PackagedProductDefinition.package.type
Element Id	PackagedProductDefinition.package.type
Definition	The physical type of the container of the medicine.
Cardinality	0..1
Type	CodeableConcept
Summary	true
PackagedProductDefinition.package.quantity
Element Id	PackagedProductDefinition.package.quantity
Definition	The quantity of this package in the medicinal product, at the current level of packaging. If specified, the outermost level is always 1.
Cardinality	0..1
Type	integer
Summary	true
PackagedProductDefinition.package.material
Element Id	PackagedProductDefinition.package.material
Definition	Material type of the package item.
Cardinality	0..*
Type	CodeableConcept
Summary	true
PackagedProductDefinition.package.alternateMaterial
Element Id	PackagedProductDefinition.package.alternateMaterial
Definition	A possible alternate material for the packaging.
Cardinality	0..*
Type	CodeableConcept
Summary	true
PackagedProductDefinition.package.shelfLifeStorage
Element Id	PackagedProductDefinition.package.shelfLifeStorage
Definition	Shelf Life and storage information.
Cardinality	0..*
Type	ProductShelfLife
Summary	true
PackagedProductDefinition.package.manufacturer
Element Id	PackagedProductDefinition.package.manufacturer
Definition	Manufacturer of this Package Item.
Cardinality	0..*
Type	Reference(Organization)
Summary	true
PackagedProductDefinition.package.property
Element Id	PackagedProductDefinition.package.property
Definition	General characteristics of this item.
Cardinality	0..*
Summary	true
PackagedProductDefinition.package.property.type
Element Id	PackagedProductDefinition.package.property.type
Definition	A code expressing the type of characteristic.
Cardinality	1..1
Type	CodeableConcept
Summary	true
PackagedProductDefinition.package.property.value[x]
Element Id	PackagedProductDefinition.package.property.value[x]
Definition	A value for the characteristic.
Cardinality	0..1
Type	CodeableConcept\|Quantity\|date\|boolean\|Attachment
[x] Note	See Choice of Data Types for further information about how to use [x]
Summary	true
PackagedProductDefinition.package.containedItem
Element Id	PackagedProductDefinition.package.containedItem
Definition	The item(s) within the packaging.
Cardinality	0..*
Summary	true
PackagedProductDefinition.package.containedItem.item
Element Id	PackagedProductDefinition.package.containedItem.item
Definition	The manufactured item or device as contained in the packaged medicinal product.
Cardinality	0..*
Type	Reference(ManufacturedItemDefinition \| DeviceDefinition)
Patterns	Reference(ManufacturedItemDefinition,DeviceDefinition): No common pattern
Summary	true
PackagedProductDefinition.package.containedItem.amount[x]
Element Id	PackagedProductDefinition.package.containedItem.amount[x]
Definition	The number of this type of item within this packaging.
Cardinality	0..1
Type	Quantity\|integer
[x] Note	See Choice of Data Types for further information about how to use [x]
Summary	true
PackagedProductDefinition.package.package
Element Id	PackagedProductDefinition.package.package
Definition	Allows containers within containers.
Cardinality	0..*
Type	See PackagedProductDefinition.package
Summary	true