Release 5 Preview #2
Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Detailed Descriptions for the elements in the PackagedProductDefinition resource.

PackagedProductDefinition
Element IdPackagedProductDefinition
Definition

A medically related item or items, in a container or package.

Cardinality0..*
TypeDomainResource
Summarytrue
PackagedProductDefinition.identifier
Element IdPackagedProductDefinition.identifier
Definition

Unique identifier.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
PackagedProductDefinition.name
Element IdPackagedProductDefinition.name
Definition

A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc.

Cardinality0..1
Typestring
Summarytrue
PackagedProductDefinition.type
Element IdPackagedProductDefinition.type
Definition

A high level category e.g. medicinal product, raw material, shipping/transport container, etc.

Cardinality0..1
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.subject
Element IdPackagedProductDefinition.subject
Definition

The product that this is a pack for.

Cardinality0..*
TypeReference(MedicinalProductDefinition)
Summarytrue
PackagedProductDefinition.status
Element IdPackagedProductDefinition.status
Definition

The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status.

Cardinality0..1
Terminology BindingPublicationStatus (Preferred)
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.statusDate
Element IdPackagedProductDefinition.statusDate
Definition

The date at which the given status became applicable.

Cardinality0..1
TypedateTime
Summarytrue
PackagedProductDefinition.description
Element IdPackagedProductDefinition.description
Definition

Textual description. Note that this is not the name of the package or product.

Cardinality0..1
Typemarkdown
Summarytrue
PackagedProductDefinition.legalStatusOfSupply
Element IdPackagedProductDefinition.legalStatusOfSupply
Definition

The legal status of supply of the packaged item as classified by the regulator.

Cardinality0..1
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.marketingStatus
Element IdPackagedProductDefinition.marketingStatus
Definition

Marketing information.

Cardinality0..*
TypeMarketingStatus
Summarytrue
PackagedProductDefinition.characteristic
Element IdPackagedProductDefinition.characteristic
Definition

Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack".

Cardinality0..*
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.copackagedIndicator
Element IdPackagedProductDefinition.copackagedIndicator
Definition

States whether a drug product is supplied with another item such as a diluent or adjuvant.

Cardinality0..1
Typeboolean
Summarytrue
PackagedProductDefinition.marketingAuthorization
Element IdPackagedProductDefinition.marketingAuthorization
Definition

An authorization for this package type.

Cardinality0..1
TypeReference(RegulatedAuthorization)
Summarytrue
PackagedProductDefinition.manufacturer
Element IdPackagedProductDefinition.manufacturer
Definition

Manufacturer of this package type.

Cardinality0..*
TypeReference(Organization)
Summarytrue
PackagedProductDefinition.batchIdentifier
Element IdPackagedProductDefinition.batchIdentifier
Definition

Batch numbering.

Cardinality0..*
Summarytrue
PackagedProductDefinition.batchIdentifier.outerPackaging
Element IdPackagedProductDefinition.batchIdentifier.outerPackaging
Definition

A number appearing on the outer packaging of a specific batch.

Cardinality1..1
TypeIdentifier
Summarytrue
PackagedProductDefinition.batchIdentifier.immediatePackaging
Element IdPackagedProductDefinition.batchIdentifier.immediatePackaging
Definition

A number appearing on the immediate packaging (and not the outer packaging).

Cardinality0..1
TypeIdentifier
Summarytrue
PackagedProductDefinition.package
Element IdPackagedProductDefinition.package
Definition

A packaging item, as a container for medically related items, possibly with other packaging items within.

Cardinality0..*
Summarytrue
PackagedProductDefinition.package.identifier
Element IdPackagedProductDefinition.package.identifier
Definition

Including possibly Data Carrier Identifier.

NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
PackagedProductDefinition.package.type
Element IdPackagedProductDefinition.package.type
Definition

The physical type of the container of the items.

Cardinality0..1
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.package.quantity
Element IdPackagedProductDefinition.package.quantity
Definition

The quantity of this level of packaging in the package that contains it. If specified, the outermost level is always 1.

Cardinality0..1
Typeinteger
Summarytrue
PackagedProductDefinition.package.material
Element IdPackagedProductDefinition.package.material
Definition

Material type of the package item.

Cardinality0..*
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.package.alternateMaterial
Element IdPackagedProductDefinition.package.alternateMaterial
Definition

A possible alternate material for the packaging.

Cardinality0..*
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.package.shelfLifeStorage
Element IdPackagedProductDefinition.package.shelfLifeStorage
Definition

Shelf Life and storage information.

Cardinality0..*
TypeProductShelfLife
Summarytrue
PackagedProductDefinition.package.manufacturer
Element IdPackagedProductDefinition.package.manufacturer
Definition

Manufacturer of this package Item.

Cardinality0..*
TypeReference(Organization)
Summarytrue
PackagedProductDefinition.package.property
Element IdPackagedProductDefinition.package.property
Definition

General characteristics of this item.

Cardinality0..*
Summarytrue
PackagedProductDefinition.package.property.type
Element IdPackagedProductDefinition.package.property.type
Definition

A code expressing the type of characteristic.

Cardinality1..1
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.package.property.value[x]
Element IdPackagedProductDefinition.package.property.value[x]
Definition

A value for the characteristic.

Cardinality0..1
TypeCodeableConcept|Quantity|date|boolean|Attachment
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
PackagedProductDefinition.package.containedItem
Element IdPackagedProductDefinition.package.containedItem
Definition

The item(s) within the packaging.

Cardinality0..*
Summarytrue
PackagedProductDefinition.package.containedItem.item
Element IdPackagedProductDefinition.package.containedItem.item
Definition

The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package.

Cardinality0..*
TypeReference(ManufacturedItemDefinition | DeviceDefinition | BiologicallyDerivedProduct | NutritionProduct)
PatternsReference(ManufacturedItemDefinition,DeviceDefinition,BiologicallyDerivedProduct,NutritionProduct): No common pattern
Summarytrue
PackagedProductDefinition.package.containedItem.amount[x]
Element IdPackagedProductDefinition.package.containedItem.amount[x]
Definition

The number of this type of item within this packaging.

Cardinality0..1
TypeQuantity|integer
[x] NoteSee Choice of Data Types for further information about how to use [x]
Summarytrue
PackagedProductDefinition.package.package
Element IdPackagedProductDefinition.package.package
Definition

Allows containers within containers.

Cardinality0..*
TypeSee PackagedProductDefinition.package
Summarytrue