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See the Directory of published versions
Biomedical Research and Regulation Work Group | Maturity Level: 2 | Trial Use | Security Category: Anonymous | Compartments: No defined compartments |
A medically related item or items, in a container or package.
For an overview of this resource and others in the Medication Definition domain, also see the module page
A medically related item or items of any type, in a container or package, representing the unit that has been prepared for sale, supply, shipping or storage. These can include packaged medications, devices and other items such as food, biologicals, raw materials, cosmetics, medical fluids, gases etc. This resource represents the whole package of items, and all the packaging within, rather than the individual items themselves and may contain other packages (parent/child relationships). In some cases a "product" exists at exists at logically different levels, and therefore has a variety of available packages associated with it. Typically the packages are associated with different sizes/quantities.
This resource is usually used with MedicinalProductDefinition, via the productFor relationship. For cases where only a subset of PackagedProductDefinition is need in a product, use as a contained resource to MPD may be appropriate. See MedicinalProductDefinition for an example.
The PackagedProductDefinition resource covers two main areas - package types that exist for a product (linked via productFor), and the packaging within those packages.
These can be thought of as the "package type" and the "packaging" respectively. The package type is covered by the PackagedProductDefinition class and the packaging by the Package backbone element (broadly the left and right of the UML model). It is possible to leave either part un-populated.
A package type can be documented without needing to say in detail what physical packaging or items are within it. This is common in many drug dictionaries, which list package types, but not their internals.
Conversely it is possible to only populate the Package backbone, and child classes, to cover packaging of an item but not say anything about the product outer packaging or the overall package that will eventually be on sale. This would be appropriate when focusing on the physical product and the inner packaging, perhaps at a manufacturing stage, without needing to populate package details not relevant (or not existing) at that phase.
Other implementations will use both "halves". A single application could start by using the Package class for packaging and then populate the package type data later on.
It is very important that a consistent representation is used. Packaging always uses the Package backbone, whether or not there are any package type properties documented. A diagram of this is shown on the Medication Definition module page.
This resource has two recursive relationships. One is primarily intended to be "internal" to the package - for package layers and contents, and the other for aggregated packages (e.g. for wholesaling) that are made up of other packages.
Feedback
In order to properly meet all packaging uses cases,
consistent representation of different package information and recursive relationships are aspects of this
resource that BR&R workgroup are particularly seeking implementation feedback on.
(Comments links are found at the bottom of each page.)
Structure
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
PackagedProductDefinition | TU | DomainResource | A medically related item or items, in a container or package Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | |
identifier | Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
name | Σ | 0..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc |
type | Σ | 0..1 | CodeableConcept | A high level category e.g. medicinal product, raw material, shipping container etc Binding: Package Type (Example) |
packageFor | Σ | 0..* | Reference(MedicinalProductDefinition) | The product that this is a pack for |
status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (Preferred) |
statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable |
containedItemQuantity | Σ | 0..* | Quantity | 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) |
description | Σ | 0..1 | markdown | Textual description. Note that this is not the name of the package or product |
legalStatusOfSupply | Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator |
code | Σ | 0..1 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: Legal Status Of Supply (Example) |
jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: Jurisdiction ValueSet (Example) |
marketingStatus | Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated |
copackagedIndicator | Σ | 0..1 | boolean | Identifies if the drug product is supplied with another item such as a diluent or adjuvant |
manufacturer | Σ | 0..* | Reference(Organization) | Manufacturer of this package type (multiple means these are all possible manufacturers) |
attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the packaged product |
packaging | Σ | 0..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap |
identifier | Σ | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier |
type | Σ | 0..1 | CodeableConcept | The physical type of the container of the items Binding: Packaging Type (Example) |
componentPart | Σ | 0..1 | boolean | 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) |
quantity | Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) |
material | Σ | 0..* | CodeableConcept | Material type of the package item Binding: Package Material (Example) |
alternateMaterial | Σ | 0..* | CodeableConcept | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: Package Material (Example) |
shelfLifeStorage | Σ | 0..* | ProductShelfLife | Shelf Life and storage information |
manufacturer | Σ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) |
property | Σ | 0..* | BackboneElement | General characteristics of this item |
type | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: Product Characteristic (Example) |
value[x] | Σ | 0..1 | A value for the characteristic | |
valueCodeableConcept | CodeableConcept | |||
valueQuantity | Quantity | |||
valueDate | date | |||
valueBoolean | boolean | |||
valueAttachment | Attachment | |||
containedItem | Σ | 0..* | BackboneElement | The item(s) within the packaging |
item | Σ | 1..1 | CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) | 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 |
amount | Σ | 0..1 | Quantity | 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) |
packaging | Σ | 0..* | see packaging | Allows containers (and parts of containers) within containers, still as a part of single packaged product |
characteristic | Σ | 0..* | see property | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" |
Documentation for this format |
See the Extensions for this resource
UML Diagram (Legend)
XML Template
<PackagedProductDefinition xmlns="http://hl7.org/fhir"> <!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier A unique identifier for this package as whole - not for the content of the package --></identifier> <name value="[string]"/><!-- 0..1 A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc --> <type><!-- 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping container etc --></type> <packageFor><!-- 0..* Reference(MedicinalProductDefinition) The product that this is a pack for --></packageFor> <status><!-- 0..1 CodeableConcept The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status --></status> <statusDate value="[dateTime]"/><!-- 0..1 The date at which the given status became applicable --> <containedItemQuantity><!-- 0..* Quantity 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) --></containedItemQuantity> <description value="[markdown]"/><!-- 0..1 Textual description. Note that this is not the name of the package or product --> <legalStatusOfSupply> <!-- 0..* The legal status of supply of the packaged item as classified by the regulator --> <code><!-- 0..1 CodeableConcept The actual status of supply. In what situation this package type may be supplied for use --></code> <jurisdiction><!-- 0..1 CodeableConcept The place where the legal status of supply applies --></jurisdiction> </legalStatusOfSupply> <marketingStatus><!-- 0..* MarketingStatus Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated --></marketingStatus> <copackagedIndicator value="[boolean]"/><!-- 0..1 Identifies if the drug product is supplied with another item such as a diluent or adjuvant --> <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this package type (multiple means these are all possible manufacturers) --></manufacturer> <attachedDocument><!-- 0..* Reference(DocumentReference) Additional information or supporting documentation about the packaged product --></attachedDocument> <packaging> <!-- 0..1 A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap --> <identifier><!-- 0..* Identifier An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier --></identifier> <type><!-- 0..1 CodeableConcept The physical type of the container of the items --></type> <componentPart value="[boolean]"/><!-- 0..1 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) --> <quantity value="[integer]"/><!-- 0..1 The quantity of this level of packaging in the package that contains it (with the outermost level being 1) --> <material><!-- 0..* CodeableConcept Material type of the package item --></material> <alternateMaterial><!-- 0..* CodeableConcept A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material --></alternateMaterial> <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage> <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers) --></manufacturer> <property> <!-- 0..* General characteristics of this item --> <type><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></type> <value[x]><!-- 0..1 CodeableConcept|Quantity|date|boolean|Attachment A value for the characteristic --></value[x]> </property> <containedItem> <!-- 0..* The item(s) within the packaging --> <item><!-- 1..1 CodeableReference(BiologicallyDerivedProduct|DeviceDefinition| ManufacturedItemDefinition|NutritionProduct|PackagedProductDefinition) 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 --></item> <amount><!-- 0..1 Quantity 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) --></amount> </containedItem> <packaging><!-- 0..* Content as for PackagedProductDefinition.packaging Allows containers (and parts of containers) within containers, still as a part of single packaged product --></packaging> </packaging> <characteristic><!-- 0..* Content as for PackagedProductDefinition.packaging.property Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" --></characteristic> </PackagedProductDefinition>
JSON Template
{ "resourceType" : "PackagedProductDefinition", // from Resource: id, meta, implicitRules, and language // from DomainResource: text, contained, extension, and modifierExtension "identifier" : [{ Identifier }], // A unique identifier for this package as whole - not for the content of the package "name" : "<string>", // A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc "type" : { CodeableConcept }, // A high level category e.g. medicinal product, raw material, shipping container etc "packageFor" : [{ Reference(MedicinalProductDefinition) }], // The product that this is a pack for "status" : { CodeableConcept }, // The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status "statusDate" : "<dateTime>", // The date at which the given status became applicable "containedItemQuantity" : [{ Quantity }], // 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) "description" : "<markdown>", // Textual description. Note that this is not the name of the package or product "legalStatusOfSupply" : [{ // The legal status of supply of the packaged item as classified by the regulator "code" : { CodeableConcept }, // The actual status of supply. In what situation this package type may be supplied for use "jurisdiction" : { CodeableConcept } // The place where the legal status of supply applies }], "marketingStatus" : [{ MarketingStatus }], // Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated "copackagedIndicator" : <boolean>, // Identifies if the drug product is supplied with another item such as a diluent or adjuvant "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this package type (multiple means these are all possible manufacturers) "attachedDocument" : [{ Reference(DocumentReference) }], // Additional information or supporting documentation about the packaged product "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 "identifier" : [{ Identifier }], // An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier "type" : { CodeableConcept }, // The physical type of the container of the items "componentPart" : <boolean>, // 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) "quantity" : <integer>, // The quantity of this level of packaging in the package that contains it (with the outermost level being 1) "material" : [{ CodeableConcept }], // Material type of the package item "alternateMaterial" : [{ CodeableConcept }], // A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this packaging item (multiple means these are all potential manufacturers) "property" : [{ // General characteristics of this item "type" : { CodeableConcept }, // R! A code expressing the type of characteristic // value[x]: A value for the characteristic. One of these 5: "valueCodeableConcept" : { CodeableConcept }, "valueQuantity" : { Quantity }, "valueDate" : "<date>", "valueBoolean" : <boolean>, "valueAttachment" : { Attachment } }], "containedItem" : [{ // The item(s) within the packaging "item" : { CodeableReference(BiologicallyDerivedProduct|DeviceDefinition| ManufacturedItemDefinition|NutritionProduct|PackagedProductDefinition) }, // R! 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 "amount" : { Quantity } // 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) }], "packaging" : [{ Content as for PackagedProductDefinition.packaging }] // Allows containers (and parts of containers) within containers, still as a part of single packaged product }, "characteristic" : [{ Content as for PackagedProductDefinition.packaging.property }] // Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" }
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> . [ a fhir:PackagedProductDefinition; fhir:nodeRole fhir:treeRoot; # if this is the parser root # from Resource: .id, .meta, .implicitRules, and .language # from DomainResource: .text, .contained, .extension, and .modifierExtension fhir:identifier ( [ Identifier ] ... ) ; # 0..* A unique identifier for this package as whole - not for the content of the package fhir:name [ string ] ; # 0..1 A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc fhir:type [ CodeableConcept ] ; # 0..1 A high level category e.g. medicinal product, raw material, shipping container etc fhir:packageFor ( [ Reference(MedicinalProductDefinition) ] ... ) ; # 0..* The product that this is a pack for fhir:status [ CodeableConcept ] ; # 0..1 The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status fhir:statusDate [ dateTime ] ; # 0..1 The date at which the given status became applicable fhir:containedItemQuantity ( [ Quantity ] ... ) ; # 0..* 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) fhir:description [ markdown ] ; # 0..1 Textual description. Note that this is not the name of the package or product fhir:legalStatusOfSupply ( [ # 0..* The legal status of supply of the packaged item as classified by the regulator fhir:code [ CodeableConcept ] ; # 0..1 The actual status of supply. In what situation this package type may be supplied for use fhir:jurisdiction [ CodeableConcept ] ; # 0..1 The place where the legal status of supply applies ] ... ) ; fhir:marketingStatus ( [ MarketingStatus ] ... ) ; # 0..* Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated fhir:copackagedIndicator [ boolean ] ; # 0..1 Identifies if the drug product is supplied with another item such as a diluent or adjuvant fhir:manufacturer ( [ Reference(Organization) ] ... ) ; # 0..* Manufacturer of this package type (multiple means these are all possible manufacturers) fhir:attachedDocument ( [ Reference(DocumentReference) ] ... ) ; # 0..* Additional information or supporting documentation about the packaged product fhir:packaging [ # 0..1 A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap fhir:identifier ( [ Identifier ] ... ) ; # 0..* An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier fhir:type [ CodeableConcept ] ; # 0..1 The physical type of the container of the items fhir:componentPart [ boolean ] ; # 0..1 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) fhir:quantity [ integer ] ; # 0..1 The quantity of this level of packaging in the package that contains it (with the outermost level being 1) fhir:material ( [ CodeableConcept ] ... ) ; # 0..* Material type of the package item fhir:alternateMaterial ( [ CodeableConcept ] ... ) ; # 0..* A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material fhir:shelfLifeStorage ( [ ProductShelfLife ] ... ) ; # 0..* Shelf Life and storage information fhir:manufacturer ( [ Reference(Organization) ] ... ) ; # 0..* Manufacturer of this packaging item (multiple means these are all potential manufacturers) fhir:property ( [ # 0..* General characteristics of this item fhir:type [ CodeableConcept ] ; # 1..1 A code expressing the type of characteristic # value[x] : 0..1 A value for the characteristic. One of these 5 fhir:value [ a fhir:CodeableConcept ; CodeableConcept ] fhir:value [ a fhir:Quantity ; Quantity ] fhir:value [ a fhir:date ; date ] fhir:value [ a fhir:boolean ; boolean ] fhir:value [ a fhir:Attachment ; Attachment ] ] ... ) ; fhir:containedItem ( [ # 0..* The item(s) within the packaging fhir:item [ CodeableReference(BiologicallyDerivedProduct|DeviceDefinition|ManufacturedItemDefinition| NutritionProduct|PackagedProductDefinition) ] ; # 1..1 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 fhir:amount [ Quantity ] ; # 0..1 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) ] ... ) ; fhir:packaging ( [ See PackagedProductDefinition.packaging ] ... ) ; # 0..* Allows containers (and parts of containers) within containers, still as a part of single packaged product ] ; fhir:characteristic ( [ See PackagedProductDefinition.packaging.property ] ... ) ; # 0..* Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" ]
Changes from both R4 and R4B
This resource did not exist in Release R4
See the Full Difference for further information
This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.
Structure
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
PackagedProductDefinition | TU | DomainResource | A medically related item or items, in a container or package Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | |
identifier | Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package |
name | Σ | 0..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc |
type | Σ | 0..1 | CodeableConcept | A high level category e.g. medicinal product, raw material, shipping container etc Binding: Package Type (Example) |
packageFor | Σ | 0..* | Reference(MedicinalProductDefinition) | The product that this is a pack for |
status | ?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (Preferred) |
statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable |
containedItemQuantity | Σ | 0..* | Quantity | 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) |
description | Σ | 0..1 | markdown | Textual description. Note that this is not the name of the package or product |
legalStatusOfSupply | Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator |
code | Σ | 0..1 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: Legal Status Of Supply (Example) |
jurisdiction | Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: Jurisdiction ValueSet (Example) |
marketingStatus | Σ | 0..* | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated |
copackagedIndicator | Σ | 0..1 | boolean | Identifies if the drug product is supplied with another item such as a diluent or adjuvant |
manufacturer | Σ | 0..* | Reference(Organization) | Manufacturer of this package type (multiple means these are all possible manufacturers) |
attachedDocument | Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the packaged product |
packaging | Σ | 0..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap |
identifier | Σ | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier |
type | Σ | 0..1 | CodeableConcept | The physical type of the container of the items Binding: Packaging Type (Example) |
componentPart | Σ | 0..1 | boolean | 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) |
quantity | Σ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) |
material | Σ | 0..* | CodeableConcept | Material type of the package item Binding: Package Material (Example) |
alternateMaterial | Σ | 0..* | CodeableConcept | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: Package Material (Example) |
shelfLifeStorage | Σ | 0..* | ProductShelfLife | Shelf Life and storage information |
manufacturer | Σ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) |
property | Σ | 0..* | BackboneElement | General characteristics of this item |
type | Σ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: Product Characteristic (Example) |
value[x] | Σ | 0..1 | A value for the characteristic | |
valueCodeableConcept | CodeableConcept | |||
valueQuantity | Quantity | |||
valueDate | date | |||
valueBoolean | boolean | |||
valueAttachment | Attachment | |||
containedItem | Σ | 0..* | BackboneElement | The item(s) within the packaging |
item | Σ | 1..1 | CodeableReference(ManufacturedItemDefinition | DeviceDefinition | PackagedProductDefinition | BiologicallyDerivedProduct | NutritionProduct) | 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 |
amount | Σ | 0..1 | Quantity | 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) |
packaging | Σ | 0..* | see packaging | Allows containers (and parts of containers) within containers, still as a part of single packaged product |
characteristic | Σ | 0..* | see property | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" |
Documentation for this format |
See the Extensions for this resource
XML Template
<PackagedProductDefinition xmlns="http://hl7.org/fhir"> <!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier A unique identifier for this package as whole - not for the content of the package --></identifier> <name value="[string]"/><!-- 0..1 A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc --> <type><!-- 0..1 CodeableConcept A high level category e.g. medicinal product, raw material, shipping container etc --></type> <packageFor><!-- 0..* Reference(MedicinalProductDefinition) The product that this is a pack for --></packageFor> <status><!-- 0..1 CodeableConcept The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status --></status> <statusDate value="[dateTime]"/><!-- 0..1 The date at which the given status became applicable --> <containedItemQuantity><!-- 0..* Quantity 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) --></containedItemQuantity> <description value="[markdown]"/><!-- 0..1 Textual description. Note that this is not the name of the package or product --> <legalStatusOfSupply> <!-- 0..* The legal status of supply of the packaged item as classified by the regulator --> <code><!-- 0..1 CodeableConcept The actual status of supply. In what situation this package type may be supplied for use --></code> <jurisdiction><!-- 0..1 CodeableConcept The place where the legal status of supply applies --></jurisdiction> </legalStatusOfSupply> <marketingStatus><!-- 0..* MarketingStatus Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated --></marketingStatus> <copackagedIndicator value="[boolean]"/><!-- 0..1 Identifies if the drug product is supplied with another item such as a diluent or adjuvant --> <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this package type (multiple means these are all possible manufacturers) --></manufacturer> <attachedDocument><!-- 0..* Reference(DocumentReference) Additional information or supporting documentation about the packaged product --></attachedDocument> <packaging> <!-- 0..1 A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap --> <identifier><!-- 0..* Identifier An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier --></identifier> <type><!-- 0..1 CodeableConcept The physical type of the container of the items --></type> <componentPart value="[boolean]"/><!-- 0..1 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) --> <quantity value="[integer]"/><!-- 0..1 The quantity of this level of packaging in the package that contains it (with the outermost level being 1) --> <material><!-- 0..* CodeableConcept Material type of the package item --></material> <alternateMaterial><!-- 0..* CodeableConcept A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material --></alternateMaterial> <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage> <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this packaging item (multiple means these are all potential manufacturers) --></manufacturer> <property> <!-- 0..* General characteristics of this item --> <type><!-- 1..1 CodeableConcept A code expressing the type of characteristic --></type> <value[x]><!-- 0..1 CodeableConcept|Quantity|date|boolean|Attachment A value for the characteristic --></value[x]> </property> <containedItem> <!-- 0..* The item(s) within the packaging --> <item><!-- 1..1 CodeableReference(BiologicallyDerivedProduct|DeviceDefinition| ManufacturedItemDefinition|NutritionProduct|PackagedProductDefinition) 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 --></item> <amount><!-- 0..1 Quantity 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) --></amount> </containedItem> <packaging><!-- 0..* Content as for PackagedProductDefinition.packaging Allows containers (and parts of containers) within containers, still as a part of single packaged product --></packaging> </packaging> <characteristic><!-- 0..* Content as for PackagedProductDefinition.packaging.property Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" --></characteristic> </PackagedProductDefinition>
JSON Template
{ "resourceType" : "PackagedProductDefinition", // from Resource: id, meta, implicitRules, and language // from DomainResource: text, contained, extension, and modifierExtension "identifier" : [{ Identifier }], // A unique identifier for this package as whole - not for the content of the package "name" : "<string>", // A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc "type" : { CodeableConcept }, // A high level category e.g. medicinal product, raw material, shipping container etc "packageFor" : [{ Reference(MedicinalProductDefinition) }], // The product that this is a pack for "status" : { CodeableConcept }, // The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status "statusDate" : "<dateTime>", // The date at which the given status became applicable "containedItemQuantity" : [{ Quantity }], // 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) "description" : "<markdown>", // Textual description. Note that this is not the name of the package or product "legalStatusOfSupply" : [{ // The legal status of supply of the packaged item as classified by the regulator "code" : { CodeableConcept }, // The actual status of supply. In what situation this package type may be supplied for use "jurisdiction" : { CodeableConcept } // The place where the legal status of supply applies }], "marketingStatus" : [{ MarketingStatus }], // Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated "copackagedIndicator" : <boolean>, // Identifies if the drug product is supplied with another item such as a diluent or adjuvant "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this package type (multiple means these are all possible manufacturers) "attachedDocument" : [{ Reference(DocumentReference) }], // Additional information or supporting documentation about the packaged product "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 "identifier" : [{ Identifier }], // An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier "type" : { CodeableConcept }, // The physical type of the container of the items "componentPart" : <boolean>, // 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) "quantity" : <integer>, // The quantity of this level of packaging in the package that contains it (with the outermost level being 1) "material" : [{ CodeableConcept }], // Material type of the package item "alternateMaterial" : [{ CodeableConcept }], // A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this packaging item (multiple means these are all potential manufacturers) "property" : [{ // General characteristics of this item "type" : { CodeableConcept }, // R! A code expressing the type of characteristic // value[x]: A value for the characteristic. One of these 5: "valueCodeableConcept" : { CodeableConcept }, "valueQuantity" : { Quantity }, "valueDate" : "<date>", "valueBoolean" : <boolean>, "valueAttachment" : { Attachment } }], "containedItem" : [{ // The item(s) within the packaging "item" : { CodeableReference(BiologicallyDerivedProduct|DeviceDefinition| ManufacturedItemDefinition|NutritionProduct|PackagedProductDefinition) }, // R! 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 "amount" : { Quantity } // 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) }], "packaging" : [{ Content as for PackagedProductDefinition.packaging }] // Allows containers (and parts of containers) within containers, still as a part of single packaged product }, "characteristic" : [{ Content as for PackagedProductDefinition.packaging.property }] // Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" }
Turtle Template
@prefix fhir: <http://hl7.org/fhir/> . [ a fhir:PackagedProductDefinition; fhir:nodeRole fhir:treeRoot; # if this is the parser root # from Resource: .id, .meta, .implicitRules, and .language # from DomainResource: .text, .contained, .extension, and .modifierExtension fhir:identifier ( [ Identifier ] ... ) ; # 0..* A unique identifier for this package as whole - not for the content of the package fhir:name [ string ] ; # 0..1 A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc fhir:type [ CodeableConcept ] ; # 0..1 A high level category e.g. medicinal product, raw material, shipping container etc fhir:packageFor ( [ Reference(MedicinalProductDefinition) ] ... ) ; # 0..* The product that this is a pack for fhir:status [ CodeableConcept ] ; # 0..1 The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status fhir:statusDate [ dateTime ] ; # 0..1 The date at which the given status became applicable fhir:containedItemQuantity ( [ Quantity ] ... ) ; # 0..* 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) fhir:description [ markdown ] ; # 0..1 Textual description. Note that this is not the name of the package or product fhir:legalStatusOfSupply ( [ # 0..* The legal status of supply of the packaged item as classified by the regulator fhir:code [ CodeableConcept ] ; # 0..1 The actual status of supply. In what situation this package type may be supplied for use fhir:jurisdiction [ CodeableConcept ] ; # 0..1 The place where the legal status of supply applies ] ... ) ; fhir:marketingStatus ( [ MarketingStatus ] ... ) ; # 0..* Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated fhir:copackagedIndicator [ boolean ] ; # 0..1 Identifies if the drug product is supplied with another item such as a diluent or adjuvant fhir:manufacturer ( [ Reference(Organization) ] ... ) ; # 0..* Manufacturer of this package type (multiple means these are all possible manufacturers) fhir:attachedDocument ( [ Reference(DocumentReference) ] ... ) ; # 0..* Additional information or supporting documentation about the packaged product fhir:packaging [ # 0..1 A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap fhir:identifier ( [ Identifier ] ... ) ; # 0..* An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier fhir:type [ CodeableConcept ] ; # 0..1 The physical type of the container of the items fhir:componentPart [ boolean ] ; # 0..1 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) fhir:quantity [ integer ] ; # 0..1 The quantity of this level of packaging in the package that contains it (with the outermost level being 1) fhir:material ( [ CodeableConcept ] ... ) ; # 0..* Material type of the package item fhir:alternateMaterial ( [ CodeableConcept ] ... ) ; # 0..* A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material fhir:shelfLifeStorage ( [ ProductShelfLife ] ... ) ; # 0..* Shelf Life and storage information fhir:manufacturer ( [ Reference(Organization) ] ... ) ; # 0..* Manufacturer of this packaging item (multiple means these are all potential manufacturers) fhir:property ( [ # 0..* General characteristics of this item fhir:type [ CodeableConcept ] ; # 1..1 A code expressing the type of characteristic # value[x] : 0..1 A value for the characteristic. One of these 5 fhir:value [ a fhir:CodeableConcept ; CodeableConcept ] fhir:value [ a fhir:Quantity ; Quantity ] fhir:value [ a fhir:date ; date ] fhir:value [ a fhir:boolean ; boolean ] fhir:value [ a fhir:Attachment ; Attachment ] ] ... ) ; fhir:containedItem ( [ # 0..* The item(s) within the packaging fhir:item [ CodeableReference(BiologicallyDerivedProduct|DeviceDefinition|ManufacturedItemDefinition| NutritionProduct|PackagedProductDefinition) ] ; # 1..1 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 fhir:amount [ Quantity ] ; # 0..1 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) ] ... ) ; fhir:packaging ( [ See PackagedProductDefinition.packaging ] ... ) ; # 0..* Allows containers (and parts of containers) within containers, still as a part of single packaged product ] ; fhir:characteristic ( [ See PackagedProductDefinition.packaging.property ] ... ) ; # 0..* Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" ]
Changes from both R4 and R4B
This resource did not exist in Release R4
See the Full Difference for further information
This analysis is available for R4 as XML or JSON and for R4B as XML or JSON.
Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis
Path | ValueSet | Type | Documentation |
---|---|---|---|
PackagedProductDefinition.type | PackageType | Example | A high level categorisation of a package. |
PackagedProductDefinition.status | PublicationStatus | Preferred | The lifecycle status of an artifact. |
PackagedProductDefinition.legalStatusOfSupply.code | LegalStatusOfSupply | Example | The prescription supply types appropriate to a medicinal product |
PackagedProductDefinition.legalStatusOfSupply.jurisdiction | JurisdictionValueSet | Example | This value set defines a base set of codes for country, country subdivision and region for indicating where a resource is intended to be used. Note: The codes for countries and country subdivisions are taken from ISO 3166 while the codes for "supra-national" regions are from UN Standard country or area codes for statistical use (M49) . |
PackagedProductDefinition.packaging.type | PackagingType | Example | A type of packaging. |
PackagedProductDefinition.packaging.material | PackageMaterial | Example | A material used in the construction of packages and their components. |
PackagedProductDefinition.packaging.alternateMaterial | PackageMaterial | Example | A material used in the construction of packages and their components. |
PackagedProductDefinition.packaging.property.type | ProductCharacteristic | Example | This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. |
Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.
Name | Type | Description | Expression | In Common |
biological | reference | A biologically derived product within this packaged product | PackagedProductDefinition.packaging.containedItem.item.reference | |
contained-item | reference | Any of the contained items within this packaged product | PackagedProductDefinition.packaging.containedItem.item.reference | |
device | reference | A device within this packaged product | PackagedProductDefinition.packaging.containedItem.item.reference | |
identifier | token | Unique identifier | PackagedProductDefinition.identifier | |
manufactured-item | reference | A manufactured item of medication within this packaged product | PackagedProductDefinition.packaging.containedItem.item.reference | |
medication | reference | A manufactured item of medication within this packaged product | PackagedProductDefinition.packaging.containedItem.item.reference | |
name | token | A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc. | PackagedProductDefinition.name | |
nutrition | reference | A nutrition product within this packaged product | PackagedProductDefinition.packaging.containedItem.item.reference | |
package | reference | A complete packaged product within this packaged product | PackagedProductDefinition.packaging.containedItem.item.reference | |
package-for | reference | The product that this is a pack for | PackagedProductDefinition.packageFor (MedicinalProductDefinition) |
|
status | token | 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 | PackagedProductDefinition.status |