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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
Definition

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

Short DisplayA medically related item or items, in a container or package
Cardinality0..*
TypeDomainResource
Summaryfalse
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 DisplayA unique identifier for this package as whole - not for the content of the package
NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
PackagedProductDefinition.name
Definition

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

Short DisplayA name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
Cardinality0..1
Typestring
Summarytrue
PackagedProductDefinition.type
Definition

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

Short DisplayA high level category e.g. medicinal product, raw material, shipping container etc
Cardinality0..1
Terminology BindingPackage Type (Example)
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.packageFor
Definition

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

Short DisplayThe product that this is a pack for
Cardinality0..*
TypeReference(MedicinalProductDefinition)
Summarytrue
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 DisplayThe status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status
Cardinality0..1
Terminology BindingPublicationStatus (Preferred)
TypeCodeableConcept
Is Modifiertrue (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)
Summarytrue
PackagedProductDefinition.statusDate
Definition

The date at which the given status became applicable.

Short DisplayThe date at which the given status became applicable
Cardinality0..1
TypedateTime
Summarytrue
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 DisplayA 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)
Cardinality0..*
TypeQuantity
Summarytrue
PackagedProductDefinition.description
Definition

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

Short DisplayTextual description. Note that this is not the name of the package or product
Cardinality0..1
Typemarkdown
Summarytrue
PackagedProductDefinition.legalStatusOfSupply
Definition

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

Short DisplayThe legal status of supply of the packaged item as classified by the regulator
Cardinality0..*
Summarytrue
PackagedProductDefinition.legalStatusOfSupply.code
Definition

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

Short DisplayThe actual status of supply. In what situation this package type may be supplied for use
Cardinality0..1
Terminology BindingLegal Status Of Supply (Example)
TypeCodeableConcept
Summarytrue
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 DisplayThe place where the legal status of supply applies
Cardinality0..1
Terminology BindingJurisdiction ValueSet (Example)
TypeCodeableConcept
Summarytrue
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 DisplayAllows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated
Cardinality0..*
TypeMarketingStatus
Summarytrue
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 DisplayIdentifies if the drug product is supplied with another item such as a diluent or adjuvant
Cardinality0..1
Typeboolean
Meaning if MissingIf this value is not present, there is no statement being made about whether this is co-packaged or not. No inference can be made
Summarytrue
PackagedProductDefinition.manufacturer
Definition

Manufacturer of this package type. When there are multiple it means these are all possible manufacturers.

Short DisplayManufacturer of this package type (multiple means these are all possible manufacturers)
Cardinality0..*
TypeReference(Organization)
Summarytrue
PackagedProductDefinition.attachedDocument
Definition

Additional information or supporting documentation about the packaged product.

Short DisplayAdditional information or supporting documentation about the packaged product
Cardinality0..*
TypeReference(DocumentReference)
Summarytrue
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 DisplayA packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap
Cardinality0..1
Summarytrue
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 DisplayAn identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
NoteThis is a business identifier, not a resource identifier (see discussion)
Cardinality0..*
TypeIdentifier
Summarytrue
PackagedProductDefinition.packaging.type
Definition

The physical type of the container of the items.

Short DisplayThe physical type of the container of the items
Cardinality0..1
Terminology BindingPackaging Type (Example)
TypeCodeableConcept
Summarytrue
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 DisplayIs this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)
Cardinality0..1
Typeboolean
Meaning if MissingIf 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.
Summarytrue
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 DisplayThe quantity of this level of packaging in the package that contains it (with the outermost level being 1)
Cardinality0..1
Typeinteger
Summarytrue
PackagedProductDefinition.packaging.material
Definition

Material type of the package item.

Short DisplayMaterial type of the package item
Cardinality0..*
Terminology BindingPackage Material (Example)
TypeCodeableConcept
Summarytrue
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 DisplayA possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material
Cardinality0..*
Terminology BindingPackage Material (Example)
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.packaging.shelfLifeStorage
Definition

Shelf Life and storage information.

Short DisplayShelf Life and storage information
Cardinality0..*
TypeProductShelfLife
Summarytrue
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 DisplayManufacturer of this packaging item (multiple means these are all potential manufacturers)
Cardinality0..*
TypeReference(Organization)
Summarytrue
PackagedProductDefinition.packaging.property
Definition

General characteristics of this item.

Short DisplayGeneral characteristics of this item
Cardinality0..*
Summarytrue
PackagedProductDefinition.packaging.property.type
Definition

A code expressing the type of characteristic.

Short DisplayA code expressing the type of characteristic
Cardinality1..1
Terminology BindingProduct Characteristic (Example)
TypeCodeableConcept
Summarytrue
PackagedProductDefinition.packaging.property.value[x]
Definition

A value for the characteristic.

Short DisplayA value for the characteristic
Cardinality0..1
TypeCodeableConcept|Quantity|date|boolean|Attachment
[x] NoteSee Choice of Datatypes for further information about how to use [x]
Summarytrue
PackagedProductDefinition.packaging.containedItem
Definition

The item(s) within the packaging.

Short DisplayThe item(s) within the packaging
Cardinality0..*
Summarytrue
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 DisplayThe 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
Cardinality1..1
TypeCodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct)
Summarytrue
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 DisplayThe 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)
Cardinality0..1
TypeQuantity
Summarytrue
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 DisplayAllows containers (and parts of containers) within containers, still as a part of single packaged product
Cardinality0..*
TypeSee PackagedProductDefinition.packaging
Summarytrue
PackagedProductDefinition.characteristic
Definition

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

Short DisplayAllows the key features to be recorded, such as "hospital pack", "nurse prescribable"
Cardinality0..*
TypeSee PackagedProductDefinition.packaging.property
Summarytrue