R4 Ballot #1 #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: (v3.5.0: R4 Ballot 2). #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

Biomedical Research and Regulation Work Group Maturity Level : 0   Draft Trial Use Compartments : Not linked to any defined compartments

Detailed Descriptions for the elements in the MedicinalProductPackaged resource.

MedicinalProductPackaged
Element Id MedicinalProductPackaged
Definition

A medicinal product in a container or package.

Control 1..1
Type DomainResource
Summary true
MedicinalProductPackaged.identifier
Element Id MedicinalProductPackaged.identifier
Definition

Unique identifier.

Note This is a business identifer, not a resource identifier (see discussion )
Control 1..1
Type Identifier
Alternate Names PCID
Summary true
MedicinalProductPackaged.description
Element Id MedicinalProductPackaged.description
Definition

Textual description.

Control 0..1
Type string
Summary true
MedicinalProductPackaged.marketingStatus
Element Id MedicinalProductPackaged.marketingStatus
Definition

Marketing information.

Control 0..*
Type MarketingStatus
Summary true
MedicinalProductPackaged.marketingAuthorization
Element Id MedicinalProductPackaged.marketingAuthorization
Definition

Manufacturer of this Package Item.

Control 0..1
Type Reference ( MedicinalProductAuthorization )
Summary true
MedicinalProductPackaged.manufacturer
Element Id MedicinalProductPackaged.manufacturer
Definition

Manufacturer of this Package Item.

Control 0..*
Type Reference ( Organization )
Summary true
MedicinalProductPackaged.batchIdentifier
Element Id MedicinalProductPackaged.batchIdentifier
Definition

Batch numbering.

Control 0..*
Summary true
MedicinalProductPackaged.batchIdentifier.outerPackaging
Element Id MedicinalProductPackaged.batchIdentifier.outerPackaging
Definition

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

Control 1..1
Type Identifier
Summary true
MedicinalProductPackaged.batchIdentifier.immediatePackaging
Element Id MedicinalProductPackaged.batchIdentifier.immediatePackaging
Definition

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

Control 0..1
Type Identifier
Summary true
MedicinalProductPackaged.packageItem
Element Id MedicinalProductPackaged.packageItem
Definition

A packaging item, as a contained for medicine, possibly with other packaging items within.

Control 1..*
Summary true
MedicinalProductPackaged.packageItem.identifier
Element Id MedicinalProductPackaged.packageItem.identifier
Definition

Including possibly Data Carrier Identifier.

Note This is a business identifer, not a resource identifier (see discussion )
Control 0..*
Type Identifier
Summary true
MedicinalProductPackaged.packageItem.type
Element Id MedicinalProductPackaged.packageItem.type
Definition

The physical type of the container of the medicine.

Control 1..1
Type CodeableConcept
Summary true
MedicinalProductPackaged.packageItem.quantity
Element Id MedicinalProductPackaged.packageItem.quantity
Definition

The quantity of this package in the medicinal product, at the current level of packaging. The outermost is always 1.

Control 1..1
Type Quantity
Summary true
MedicinalProductPackaged.packageItem.material
Element Id MedicinalProductPackaged.packageItem.material
Definition

Material type of the package item.

Control 0..*
Type CodeableConcept
Summary true
MedicinalProductPackaged.packageItem.alternateMaterial
Element Id MedicinalProductPackaged.packageItem.alternateMaterial
Definition

A possible alternate material for the packaging.

Control 0..*
Type CodeableConcept
Summary true
MedicinalProductPackaged.packageItem.manufacturer Element Id MedicinalProductPackaged.packageItem.manufacturer Definition Manufacturer of this Package Item. Control 0..* Type Reference ( Organization ) Summary true MedicinalProductPackaged.packageItem.device
Element Id MedicinalProductPackaged.packageItem.device
Definition

A device accompanying a medicinal product.

Control 0..*
Type Reference ( MedicinalProductDeviceSpec | DeviceDefinition )
Summary true
MedicinalProductPackaged.packageItem.manufacturedItem
Element Id MedicinalProductPackaged.packageItem.manufacturedItem
Definition

The manufactured item as contained in the packaged medicinal product.

Control 0..*
Summary true MedicinalProductPackaged.packageItem.manufacturedItem.manufacturedDoseForm Element Id MedicinalProductPackaged.packageItem.manufacturedItem.manufacturedDoseForm Definition Dose form as manufactured and before any transformation into the pharmaceutical product. Control 1..1 Type CodeableConcept Summary true MedicinalProductPackaged.packageItem.manufacturedItem.unitOfPresentation Element Id MedicinalProductPackaged.packageItem.manufacturedItem.unitOfPresentation Definition The “real world” units in which the quantity of the manufactured item is described. Control 0..1 Type CodeableConcept Summary true MedicinalProductPackaged.packageItem.manufacturedItem.quantity Element Id MedicinalProductPackaged.packageItem.manufacturedItem.quantity Definition The quantity or "count number" of the manufactured item. Control 1..1 Type Quantity Summary true MedicinalProductPackaged.packageItem.manufacturedItem.xManufacturer Element Id MedicinalProductPackaged.packageItem.manufacturedItem.xManufacturer Definition Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues). Control 0..* Type Reference ( Organization MedicinalProductManufactured )
Summary true
MedicinalProductPackaged.packageItem.manufacturedItem.ingredient MedicinalProductPackaged.packageItem.packageItem
Element Id MedicinalProductPackaged.packageItem.manufacturedItem.ingredient MedicinalProductPackaged.packageItem.packageItem
Definition

Ingredient. Allows containers within containers.

Control 0..*
Type Reference ( MedicinalProductIngredient See MedicinalProductPackaged.packageItem )
Summary true
MedicinalProductPackaged.packageItem.manufacturedItem.physicalCharacteristics MedicinalProductPackaged.packageItem.physicalCharacteristics
Element Id MedicinalProductPackaged.packageItem.manufacturedItem.physicalCharacteristics MedicinalProductPackaged.packageItem.physicalCharacteristics
Definition

Dimensions, color etc.

Control 0..1
Type ProdCharacteristic
Summary true
MedicinalProductPackaged.packageItem.otherCharacteristics
Element Id MedicinalProductPackaged.packageItem.otherCharacteristics
Definition

Other codeable characteristics.

Control 0..*
Type CodeableConcept
Summary true
MedicinalProductPackaged.packageItem.packageItem MedicinalProductPackaged.packageItem.shelfLifeStorage
Element Id MedicinalProductPackaged.packageItem.packageItem MedicinalProductPackaged.packageItem.shelfLifeStorage
Definition

Allows containers within containers. Shelf Life and storage information.

Control 0..*
Type See MedicinalProductPackaged.packageItem Summary true MedicinalProductPackaged.packageItem.physicalCharacteristics Element Id MedicinalProductPackaged.packageItem.physicalCharacteristics Definition Dimensions, color etc. Control 0..1 Type ProdCharacteristic ProductShelfLife
Summary true
MedicinalProductPackaged.packageItem.shelfLifeStorage MedicinalProductPackaged.packageItem.manufacturer
Element Id MedicinalProductPackaged.packageItem.shelfLifeStorage MedicinalProductPackaged.packageItem.manufacturer
Definition

Shelf Life and storage information. Manufacturer of this Package Item.

Control 0..*
Type ProductShelfLife Reference ( Organization )
Summary true