--- type: "resource-definitions" title: "PackagedProductDefinition Definitions" resource: "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](/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](/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](/CodeableConcept) **Binding:** example:[package-type](/valueset-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](/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](/CodeableConcept) **Binding:** preferred:[publication-status](/valueset-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](/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](/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](/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](/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](/CodeableConcept) **Binding:** example:[legal-status-of-supply](/valueset-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](/CodeableConcept) **Binding:** example:[jurisdiction](/valueset-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](/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](/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](/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](/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](/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](/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](/CodeableConcept) **Binding:** example:[packaging-type](/valueset-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](/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](/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](/CodeableConcept) **Binding:** example:[package-material](/valueset-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](/CodeableConcept) **Binding:** example:[package-material](/valueset-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](/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](/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](/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](/CodeableConcept) **Binding:** example:[product-characteristic-codes](/valueset-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](/CodeableConcept), [Quantity](/Quantity), [date](/date), [boolean](/boolean), [Attachment](/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](/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](/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](/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