This page is part of the FHIR Specification v4.1.0: R4B Ballot. About the R4B version of FHIR. 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
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 medically related item or items, in a container or package. |
Cardinality | 0..* |
Type | DomainResource |
Summary | false |
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 package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc. |
Cardinality | 0..1 |
Type | string |
Summary | true |
PackagedProductDefinition.type | |
Element Id | PackagedProductDefinition.type |
Definition | A high level category e.g. medicinal product, raw material, shipping/transport container, etc. |
Cardinality | 0..1 |
Type | CodeableConcept |
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 item. A high level status, this is not intended to duplicate details carried elsewhere 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.containedItemQuantity | |
Element Id | PackagedProductDefinition.containedItemQuantity |
Definition | A total of the amount of items in the package, per item type. This can be considered as the pack size. This attribite is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Repeats are not to be used to represent differerent pack sizes (e.g. 20 pack vs 50 pack) - which would be different resource instances. This attribute differs from containedItem.amount in that it can give a single count of all tablet types in a pack, even when these are different manufactured items. |
Cardinality | 0..* |
Type | Quantity |
Summary | true |
PackagedProductDefinition.description | |
Element Id | PackagedProductDefinition.description |
Definition | Textual description. Note that this is not the name of the package or product. |
Cardinality | 0..1 |
Type | markdown |
Summary | true |
PackagedProductDefinition.legalStatusOfSupply | |
Element Id | PackagedProductDefinition.legalStatusOfSupply |
Definition | The legal status of supply of the packaged item 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 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 | An authorization for this package type. |
Cardinality | 0..1 |
Type | Reference(RegulatedAuthorization) |
Summary | true |
PackagedProductDefinition.manufacturer | |
Element Id | PackagedProductDefinition.manufacturer |
Definition | Manufacturer of this package type. When there are multiple it means these are all possible manufacturers. |
Cardinality | 0..* |
Type | Reference(Organization) |
Summary | true |
PackagedProductDefinition.package | |
Element Id | PackagedProductDefinition.package |
Definition | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item). |
Cardinality | 0..1 |
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 items. |
Cardinality | 0..1 |
Type | CodeableConcept |
Summary | true |
PackagedProductDefinition.package.quantity | |
Element Id | PackagedProductDefinition.package.quantity |
Definition | The quantity of this level of packaging in the package that contains it. 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. When there are multiple it means these are all possible manufacturers. |
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 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. This also allows another packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack. |
Cardinality | 0..* |
Type | CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) |
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 |