type: resource-definitionsresource: PackagedProductDefinition

PackagedProductDefinition Definitions

PackagedProductDefinition

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

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

Cardinality: 0..*

Mappings: idmp=Packaged Medicinal Product; w5=administrative.medication

PackagedProductDefinition.identifier

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

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

Cardinality: 0..*

Type: Identifier

Summary: true

Mappings: idmp=Packaged Medicinal Product.PCID; w5=FiveWs.class

PackagedProductDefinition.name

A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc

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

Mappings: idmp=n/a

PackagedProductDefinition.type

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

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

Cardinality: 0..1

Type: CodeableConcept

Binding: example:package-type

Summary: true

Mappings: idmp=n/a

PackagedProductDefinition.packageFor

The product that this is a pack for

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

Cardinality: 0..*

Type: Reference(MedicinalProductDefinition)

Summary: true

Mappings: idmp=(the link from Packaged Medicinal Product to Medicinal Product)

PackagedProductDefinition.status

The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing 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

Type: CodeableConcept

Binding: preferred:publication-status

Summary: true

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)

Mappings: idmp=n/a

PackagedProductDefinition.statusDate

The date at which the given status became applicable

Definition: The date at which the given status became applicable.

Cardinality: 0..1

Type: dateTime

Summary: true

Mappings: idmp=n/a

PackagedProductDefinition.containedItemQuantity

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)

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.

Cardinality: 0..*

Type: Quantity

Summary: true

Mappings: idmp=n/a

PackagedProductDefinition.description

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

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

Cardinality: 0..1

Type: markdown

Summary: true

Mappings: idmp=Packaged Medicinal Product.description

PackagedProductDefinition.legalStatusOfSupply

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

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

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp=Marketing Authorization.Legal Status of Supply (for a package)

PackagedProductDefinition.legalStatusOfSupply.code

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

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

Cardinality: 0..1

Type: CodeableConcept

Binding: example:legal-status-of-supply

Summary: true

Mappings: idmp=Marketing Authorization.Legal Status of Supply (for a package)

PackagedProductDefinition.legalStatusOfSupply.jurisdiction

The place where the legal status of supply applies

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

Cardinality: 0..1

Type: CodeableConcept

Binding: example:jurisdiction

Summary: true

Mappings: idmp=n/a

PackagedProductDefinition.marketingStatus

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

Definition: 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

Mappings: idmp=Packaged Medicinal Product.Marketing Status

PackagedProductDefinition.copackagedIndicator

Identifies if the drug product is supplied with another item such as a diluent or adjuvant

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.

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

Cardinality: 0..1

Type: boolean

Summary: true

Mappings: idmp=n/a

PackagedProductDefinition.manufacturer

Manufacturer of this package type (multiple means these are all possible manufacturers)

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

Cardinality: 0..*

Type: Reference(Organization)

Summary: true

Mappings: idmp=Packaged Medicinal Product.Manufacturer / Establishment (Organisation)

PackagedProductDefinition.attachedDocument

Additional information or supporting documentation about the packaged product

Definition: Additional information or supporting documentation about the packaged product.

Cardinality: 0..*

Type: Reference(DocumentReference)

Summary: true

Mappings: idmp=n/a

PackagedProductDefinition.packaging

A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap

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

Type: BackboneElement

Summary: true

Mappings: idmp=Packaged Medicinal Product.Package Item (Container), Package Item (Container).Package (Component)

PackagedProductDefinition.packaging.identifier

An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier 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).

Cardinality: 0..*

Type: Identifier

Summary: true

Mappings: idmp=Package Item (Container).Data Carrier Identifier

PackagedProductDefinition.packaging.type

The physical type of the container of the items

Definition: The physical type of the container of the items.

Cardinality: 0..1

Type: CodeableConcept

Binding: example:packaging-type

Summary: true

Mappings: idmp=Package Item (Container).Package Item (Container) Type

PackagedProductDefinition.packaging.componentPart

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)

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.

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.

Cardinality: 0..1

Type: boolean

Summary: true

Mappings: idmp=Whether this packaging item corresponds to an Package Item (Container), if false, or a Package (Component), when true

PackagedProductDefinition.packaging.quantity

The quantity of this level of packaging in the package that contains it (with the outermost level being 1)

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.

Cardinality: 0..1

Type: integer

Summary: true

Mappings: idmp=Package Item (Container).Package Item (Container) Quantity

PackagedProductDefinition.packaging.material

Material type of the package item

Definition: Material type of the package item.

Cardinality: 0..*

Type: CodeableConcept

Binding: example:package-material

Summary: true

Mappings: idmp=Package Item (Container).Material

PackagedProductDefinition.packaging.alternateMaterial

A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material

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).

Cardinality: 0..*

Type: CodeableConcept

Binding: example:package-material

Summary: true

Mappings: idmp=Package Item (Container).Alternate Material

PackagedProductDefinition.packaging.shelfLifeStorage

Shelf Life and storage information

Definition: Shelf Life and storage information.

Cardinality: 0..*

Type: ProductShelfLife

Summary: true

Mappings: idmp=Package Item (Container).Shelf Life / Storage

PackagedProductDefinition.packaging.manufacturer

Manufacturer of this packaging item (multiple means these are all potential manufacturers)

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

Cardinality: 0..*

Type: Reference(Organization)

Summary: true

Mappings: idmp=Package Item (Container).Manufacturer / Establishment (Organisation)

PackagedProductDefinition.packaging.property

General characteristics of this item

Definition: General characteristics of this item.

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp=Package Item (Container).Physical Characteristics

PackagedProductDefinition.packaging.property.type

A code expressing the type of characteristic

Definition: A code expressing the type of characteristic.

Cardinality: 1..1

Type: CodeableConcept

Binding: example:product-characteristic-codes

Summary: true

Mappings: idmp=Physical Characteristics, all attributes

PackagedProductDefinition.packaging.property.value[x]

A value for the characteristic

Definition: A value for the characteristic.

Cardinality: 0..1

Type: CodeableConcept, Quantity, date, boolean, Attachment

Summary: true

Mappings: idmp=Physical Characteristics, attribute's value

PackagedProductDefinition.packaging.containedItem

The item(s) within the packaging

Definition: The item(s) within the packaging.

Cardinality: 0..*

Type: BackboneElement

Summary: true

Mappings: idmp=Package Item (Container).Manufactured Item, Package Item (Container).Device

PackagedProductDefinition.packaging.containedItem.item

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

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).

Cardinality: 1..1

Type: CodeableReference

Summary: true

Mappings: idmp=(the link to) Package Item (Container).Manufactured Item, Package Item (Container).Device

PackagedProductDefinition.packaging.containedItem.amount

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)

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).

Cardinality: 0..1

Type: Quantity

Summary: true

Mappings: idmp=Manufactured Item.Manufactured Item Quantity

PackagedProductDefinition.packaging.packaging

Allows containers (and parts of containers) within containers, still as a part of single packaged product

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).

Cardinality: 0..*

Summary: true

Mappings: idmp=(link from Package Item (Container) to itself)

PackagedProductDefinition.characteristic

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

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

Cardinality: 0..*

Summary: true

Mappings: idmp=n/a