R6 Ballot (2nd Draft)

Publish-box (todo)

Biomedical Research and Regulation icon Work GroupMaturity Level: 2 Trial UseSecurity Category: Anonymous Compartments: No 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.

Short Display A medically related item or items, in a container or package
Cardinality 0..*
Type DomainResource
Summary false
PackagedProductDefinition.identifier
Element Id PackagedProductDefinition.identifier
Definition

A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations.

Short Display A unique identifier for this package as whole - not for the content of the package
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.

Short Display A name for this package. Typically as listed in a drug formulary, 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.

Short Display A high level category e.g. medicinal product, raw material, shipping container etc
Cardinality 0..1
Terminology Binding Package Type (Example)
Type CodeableConcept
Summary true
PackagedProductDefinition.packageFor
Element Id PackagedProductDefinition.packageFor
Definition

The product this package model relates to, not the contents of the package (for which see package.containedItem).

Short Display 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.

Short Display The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
Cardinality 0..1
Terminology Binding PublicationStatus (Preferred)
Type CodeableConcept
Is Modifier true (Reason: This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid)
Summary true
PackagedProductDefinition.statusDate
Element Id PackagedProductDefinition.statusDate
Definition

The date at which the given status became applicable.

Short Display 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 complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute 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). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource.

Short Display A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition)
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.

Short Display 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.

Short Display The legal status of supply of the packaged item as classified by the regulator
Cardinality 0..*
Summary true
PackagedProductDefinition.legalStatusOfSupply.code
Element Id PackagedProductDefinition.legalStatusOfSupply.code
Definition

The actual status of supply. Conveys in what situation this package type may be supplied for use.

Short Display The actual status of supply. In what situation this package type may be supplied for use
Cardinality 0..1
Terminology Binding Legal Status Of Supply (Example)
Type CodeableConcept
Summary true
PackagedProductDefinition.legalStatusOfSupply.jurisdiction
Element Id PackagedProductDefinition.legalStatusOfSupply.jurisdiction
Definition

The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context.

Short Display The place where the legal status of supply applies
Cardinality 0..1
Terminology Binding Jurisdiction ValueSet (Example)
Type CodeableConcept
Summary true
PackagedProductDefinition.marketingStatus
Element Id PackagedProductDefinition.marketingStatus
Definition

Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated.

Short Display Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
Cardinality 0..*
Type MarketingStatus
Summary true
PackagedProductDefinition.copackagedIndicator
Element Id PackagedProductDefinition.copackagedIndicator
Definition

Identifies if the package contains different items, such as when a drug product is supplied with another item e.g. a diluent or adjuvant.

Short Display Identifies if the drug product is supplied with another item such as a diluent or adjuvant
Cardinality 0..1
Type boolean
Meaning if Missing If this value is not present, there is no statement being made about whether this is co-packaged or not. No inference can be made
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.

Short Display Manufacturer of this package type (multiple means these are all possible manufacturers)
Cardinality 0..*
Type Reference(Organization)
Summary true
PackagedProductDefinition.attachedDocument
Element Id PackagedProductDefinition.attachedDocument
Definition

Additional information or supporting documentation about the packaged product.

Short Display Additional information or supporting documentation about the packaged product
Cardinality 0..*
Type Reference(DocumentReference)
Summary true
PackagedProductDefinition.packaging
Element Id PackagedProductDefinition.packaging
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).

Short Display A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
Cardinality 0..1
Summary true
PackagedProductDefinition.packaging.identifier
Element Id PackagedProductDefinition.packaging.identifier
Definition

A business identifier that is specific to this particular part of the packaging, often assigned by the manufacturer. Including possibly Data Carrier Identifier (a GS1 barcode).

Short Display An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
Note This is a business identifier, not a resource identifier (see discussion)
Cardinality 0..*
Type Identifier
Summary true
PackagedProductDefinition.packaging.type
Element Id PackagedProductDefinition.packaging.type
Definition

The physical type of the container of the items.

Short Display The physical type of the container of the items
Cardinality 0..1
Terminology Binding Packaging Type (Example)
Type CodeableConcept
Summary true
PackagedProductDefinition.packaging.componentPart
Element Id PackagedProductDefinition.packaging.componentPart
Definition

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). The latter type are designed be a container, but the former are not.

Short Display 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)
Cardinality 0..1
Type boolean
Meaning if Missing If absent, it cannot be assumed that the item is packaging (a container) or a part of the packaging - it is just 'packaging'. Systems can sometimes infer this from the packaging.type (e.g. bottles are containers, bottle caps are not), or from the fact that a container will usually have other items within it (though it is possible that these exist but are not mentioned). Often the distinction is not critical - and can easily be understood by humans - but if that is necessary for machine processing it is recommended that this attribute is given a value.
Summary true
PackagedProductDefinition.packaging.quantity
Element Id PackagedProductDefinition.packaging.quantity
Definition

The quantity of packaging items contained at this layer of the package. This does not relate to the number of contained items but relates solely to the number of packaging items. When looking at the outermost layer it is always 1. If there are two boxes within, at the next layer it would be 2.

Short Display The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
Cardinality 0..1
Type integer
Summary true
PackagedProductDefinition.packaging.material
Element Id PackagedProductDefinition.packaging.material
Definition

Material type of the package item.

Short Display Material type of the package item
Cardinality 0..*
Terminology Binding Package Material (Example)
Type CodeableConcept
Summary true
PackagedProductDefinition.packaging.alternateMaterial
Element Id PackagedProductDefinition.packaging.alternateMaterial
Definition

A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material (e.g. different types of plastic for a blister sleeve).

Short Display A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material
Cardinality 0..*
Terminology Binding Package Material (Example)
Type CodeableConcept
Summary true
PackagedProductDefinition.packaging.shelfLifeStorage
Element Id PackagedProductDefinition.packaging.shelfLifeStorage
Definition

Shelf Life and storage information.

Short Display Shelf Life and storage information
Cardinality 0..*
Type ProductShelfLife
Summary true
PackagedProductDefinition.packaging.manufacturer
Element Id PackagedProductDefinition.packaging.manufacturer
Definition

Manufacturer of this packaging item. When there are multiple values each one is a potential manufacturer of this packaging item.

Short Display Manufacturer of this packaging item (multiple means these are all potential manufacturers)
Cardinality 0..*
Type Reference(Organization)
Summary true
PackagedProductDefinition.packaging.property
Element Id PackagedProductDefinition.packaging.property
Definition

General characteristics of this item.

Short Display General characteristics of this item
Cardinality 0..*
Summary true
PackagedProductDefinition.packaging.property.type
Element Id PackagedProductDefinition.packaging.property.type
Definition

A code expressing the type of characteristic.

Short Display A code expressing the type of characteristic
Cardinality 1..1
Terminology Binding Product Characteristic (Example)
Type CodeableConcept
Summary true
PackagedProductDefinition.packaging.property.value[x]
Element Id PackagedProductDefinition.packaging.property.value[x]
Definition

A value for the characteristic.

Short Display A value for the characteristic
Cardinality 0..1
Type CodeableConcept|Quantity|date|boolean|Attachment
[x] Note See Choice of Datatypes for further information about how to use [x]
Summary true
PackagedProductDefinition.packaging.containedItem
Element Id PackagedProductDefinition.packaging.containedItem
Definition

The item(s) within the packaging.

Short Display The item(s) within the packaging
Cardinality 0..*
Summary true
PackagedProductDefinition.packaging.containedItem.item
Element Id PackagedProductDefinition.packaging.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 whole 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 (for layers within one package, use PackagedProductDefinition.packaging.packaging).

Short Display 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
Cardinality 1..1
Type CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct)
Summary true
PackagedProductDefinition.packaging.containedItem.amount
Element Id PackagedProductDefinition.packaging.containedItem.amount
Definition

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).

Short Display 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)
Cardinality 0..1
Type Quantity
Summary true
PackagedProductDefinition.packaging.packaging
Element Id PackagedProductDefinition.packaging.packaging
Definition

Allows containers (and parts of containers) within containers, still as a part of a single packaged product. See also PackagedProductDefinition.packaging.containedItem.item(PackagedProductDefinition).

Short Display Allows containers (and parts of containers) within containers, still as a part of single packaged product
Cardinality 0..*
Type See PackagedProductDefinition.packaging
Summary true
PackagedProductDefinition.characteristic
Element Id PackagedProductDefinition.characteristic
Definition

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

Short Display Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Cardinality 0..*
Type See PackagedProductDefinition.packaging.property
Summary true