This page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions

15.2 Resource PackagedProductDefinition - Content

Biomedical Research and Regulation icon

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.

15.2.1 Scope and Usage

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.

15.2.1.1 Consistent representation of different package aspects

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.

15.2.1.2 Recursive relationships in this resource

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.

PackagedProductDefinition.package.package
This recursive relationship is used for the inner parts and containers within a package - the package being indivisible and marketed or prescribed as a whole entity. However see also the "referenceable" packaging case in the next bullet.
PackagedProductDefinition.package.containedItem.item(PackagedProductDefinition)
This recursive route is primarily for cases where the whole (indivisible) package is then aggregated into another, divisible, package - for example a warehousing or transport pack. This represents a package of packages. It is not generally used for the internal parts of a single package (see previous bullet). However for cases where there is a need to represent the distinct regulation of specific inner parts of a package, and so a need for these to be directly referenceable as packaging layers by other resources, this relationship SHOULD also be used for packaging within the package.

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.)

15.2.2 References to this Resource

Resource References: ActivityDefinition, MedicationKnowledge, itself, PlanDefinition and RegulatedAuthorization

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

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.

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

15.2.3.1 Terminology Bindings

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.

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 icon while the codes for "supra-national" regions are from UN Standard country or area codes for statistical use (M49) icon .

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.

15.2.4 Search Parameters

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