This page is part of the FHIR Specification (v4.3.0: R4B - STU). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

15.2 Resource PackagedProductDefinition - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 1

Trial Use

Security Category: Anonymous

Compartments: Not linked to any defined compartments

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

15.2.0.1 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 or similar use. These can include packaged medications, devices and other items such as food, biologicals, raw materials, medical fluids, gases etc. This resource represents the whole package of items, and all the packaging within, rather than the individual items themselves. In some cases a "product" exists at a logically higher level, which has a variety of available packages associated with it, typically of different sizes.

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.

15.2.0.2 Consistent representation of different package aspects

15.2.1 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.

15.2.1.1 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

This resource is referenced by itself, PlanDefinition and RegulatedAuthorization.

This resource does not implement any patterns.

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
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 PackageType (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 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
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 LegalStatusOfSupply (Example)
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Jurisdiction (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
characteristic	Σ	0..*	CodeableConcept	Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" PackageCharacteristic (Example)
copackagedIndicator	Σ	0..1	boolean	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)
package	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 PackagingType (Example)
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 PackageMaterial (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 PackageMaterial (Example)
shelfLifeStorage	Σ	0..*	BackboneElement	Shelf Life and storage information
type	Σ	0..1	CodeableConcept	This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
period[x]	Σ	0..1		The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
periodDuration			Duration
periodString			string
specialPrecautionsForStorage	Σ	0..*	CodeableConcept	Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this package Item (multiple means these are all possible manufacturers)
property	Σ	0..*	BackboneElement	General characteristics of this item
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic ProductCharacteristic (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
package	Σ	0..*	see package	Allows containers (and parts of containers) within containers, still a single packaged product
Documentation for this format

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 --></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 --></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>
 <characteristic><!-- 0..* CodeableConcept Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" --></characteristic>
 <copackagedIndicator value="[boolean]"/><!-- 0..1 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>
 <package>  <!-- 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>
  <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..* Shelf Life and storage information -->
   <type><!-- 0..1 CodeableConcept This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified --></type>
   <period[x]><!-- 0..1 Duration|string The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used --></period[x]>
   <specialPrecautionsForStorage><!-- 0..* CodeableConcept Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified --></specialPrecautionsForStorage>
  </shelfLifeStorage>
  <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this package Item (multiple means these are all possible 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 --></amount>
  </containedItem>
  <package><!-- 0..* Content as for PackagedProductDefinition.package Allows containers (and parts of containers) within containers, still a single packaged product --></package>
 </package>
</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
  "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
  "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
  "characteristic" : [{ CodeableConcept }], // Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
  "copackagedIndicator" : <boolean>, // 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)
  "package" : { // 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
    "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" : [{ // Shelf Life and storage information
      "type" : { CodeableConcept }, // This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
      // period[x]: 
       The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used. One of these 2:
      "periodDuration" : { Duration },
      "periodString" : "<string>",
      "specialPrecautionsForStorage" : [{ CodeableConcept }] // Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified
    }],
    "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this package Item (multiple means these are all possible 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
    }],
    "package" : [{ Content as for PackagedProductDefinition.package }] // Allows containers (and parts of containers) within containers, still a single packaged product
  }
}

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:PackagedProductDefinition.identifier [ Identifier ], ... ; # 0..* A unique identifier for this package as whole
  fhir:PackagedProductDefinition.name [ string ]; # 0..1 A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
  fhir:PackagedProductDefinition.type [ CodeableConcept ]; # 0..1 A high level category e.g. medicinal product, raw material, shipping container etc
  fhir:PackagedProductDefinition.packageFor [ Reference(MedicinalProductDefinition) ], ... ; # 0..* The product that this is a pack for
  fhir:PackagedProductDefinition.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:PackagedProductDefinition.statusDate [ dateTime ]; # 0..1 The date at which the given status became applicable
  fhir:PackagedProductDefinition.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
  fhir:PackagedProductDefinition.description [ markdown ]; # 0..1 Textual description. Note that this is not the name of the package or product
  fhir:PackagedProductDefinition.legalStatusOfSupply [ # 0..* The legal status of supply of the packaged item as classified by the regulator
    fhir:PackagedProductDefinition.legalStatusOfSupply.code [ CodeableConcept ]; # 0..1 The actual status of supply. In what situation this package type may be supplied for use
    fhir:PackagedProductDefinition.legalStatusOfSupply.jurisdiction [ CodeableConcept ]; # 0..1 The place where the legal status of supply applies
  ], ...;
  fhir:PackagedProductDefinition.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:PackagedProductDefinition.characteristic [ CodeableConcept ], ... ; # 0..* Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
  fhir:PackagedProductDefinition.copackagedIndicator [ boolean ]; # 0..1 If the drug product is supplied with another item such as a diluent or adjuvant
  fhir:PackagedProductDefinition.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this package type (multiple means these are all possible manufacturers)
  fhir:PackagedProductDefinition.package [ # 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:PackagedProductDefinition.package.identifier [ Identifier ], ... ; # 0..* An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
    fhir:PackagedProductDefinition.package.type [ CodeableConcept ]; # 0..1 The physical type of the container of the items
    fhir:PackagedProductDefinition.package.quantity [ integer ]; # 0..1 The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
    fhir:PackagedProductDefinition.package.material [ CodeableConcept ], ... ; # 0..* Material type of the package item
    fhir:PackagedProductDefinition.package.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:PackagedProductDefinition.package.shelfLifeStorage [ # 0..* Shelf Life and storage information
      fhir:PackagedProductDefinition.package.shelfLifeStorage.type [ CodeableConcept ]; # 0..1 This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
      # PackagedProductDefinition.package.shelfLifeStorage.period[x] : 0..1 The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used. One of these 2
        fhir:PackagedProductDefinition.package.shelfLifeStorage.periodDuration [ Duration ]
        fhir:PackagedProductDefinition.package.shelfLifeStorage.periodString [ string ]
      fhir:PackagedProductDefinition.package.shelfLifeStorage.specialPrecautionsForStorage [ CodeableConcept ], ... ; # 0..* Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified
    ], ...;
    fhir:PackagedProductDefinition.package.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this package Item (multiple means these are all possible manufacturers)
    fhir:PackagedProductDefinition.package.property [ # 0..* General characteristics of this item
      fhir:PackagedProductDefinition.package.property.type [ CodeableConcept ]; # 1..1 A code expressing the type of characteristic
      # PackagedProductDefinition.package.property.value[x] : 0..1 A value for the characteristic. One of these 5
        fhir:PackagedProductDefinition.package.property.valueCodeableConcept [ CodeableConcept ]
        fhir:PackagedProductDefinition.package.property.valueQuantity [ Quantity ]
        fhir:PackagedProductDefinition.package.property.valueDate [ date ]
        fhir:PackagedProductDefinition.package.property.valueBoolean [ boolean ]
        fhir:PackagedProductDefinition.package.property.valueAttachment [ Attachment ]
    ], ...;
    fhir:PackagedProductDefinition.package.containedItem [ # 0..* The item(s) within the packaging
      fhir:PackagedProductDefinition.package.containedItem.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:PackagedProductDefinition.package.containedItem.amount [ Quantity ]; # 0..1 The number of this type of item within this packaging
    ], ...;
    fhir:PackagedProductDefinition.package.package [ See PackagedProductDefinition.package ], ... ; # 0..* Allows containers (and parts of containers) within containers, still a single packaged product
  ];
]

Changes since R4

This resource did not exist in Release 3

This analysis is available as XML or JSON.

Conversions between R3 and R4

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
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 PackageType (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 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
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 LegalStatusOfSupply (Example)
jurisdiction	Σ	0..1	CodeableConcept	The place where the legal status of supply applies Jurisdiction (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
characteristic	Σ	0..*	CodeableConcept	Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" PackageCharacteristic (Example)
copackagedIndicator	Σ	0..1	boolean	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)
package	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 PackagingType (Example)
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 PackageMaterial (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 PackageMaterial (Example)
shelfLifeStorage	Σ	0..*	BackboneElement	Shelf Life and storage information
type	Σ	0..1	CodeableConcept	This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
period[x]	Σ	0..1		The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used
periodDuration			Duration
periodString			string
specialPrecautionsForStorage	Σ	0..*	CodeableConcept	Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this package Item (multiple means these are all possible manufacturers)
property	Σ	0..*	BackboneElement	General characteristics of this item
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic ProductCharacteristic (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
package	Σ	0..*	see package	Allows containers (and parts of containers) within containers, still a single packaged product
Documentation for this format

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 --></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 --></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>
 <characteristic><!-- 0..* CodeableConcept Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" --></characteristic>
 <copackagedIndicator value="[boolean]"/><!-- 0..1 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>
 <package>  <!-- 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>
  <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..* Shelf Life and storage information -->
   <type><!-- 0..1 CodeableConcept This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified --></type>
   <period[x]><!-- 0..1 Duration|string The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used --></period[x]>
   <specialPrecautionsForStorage><!-- 0..* CodeableConcept Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified --></specialPrecautionsForStorage>
  </shelfLifeStorage>
  <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this package Item (multiple means these are all possible 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 --></amount>
  </containedItem>
  <package><!-- 0..* Content as for PackagedProductDefinition.package Allows containers (and parts of containers) within containers, still a single packaged product --></package>
 </package>
</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
  "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
  "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
  "characteristic" : [{ CodeableConcept }], // Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
  "copackagedIndicator" : <boolean>, // 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)
  "package" : { // 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
    "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" : [{ // Shelf Life and storage information
      "type" : { CodeableConcept }, // This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
      // period[x]: 
       The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used. One of these 2:
      "periodDuration" : { Duration },
      "periodString" : "<string>",
      "specialPrecautionsForStorage" : [{ CodeableConcept }] // Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified
    }],
    "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this package Item (multiple means these are all possible 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
    }],
    "package" : [{ Content as for PackagedProductDefinition.package }] // Allows containers (and parts of containers) within containers, still a single packaged product
  }
}

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:PackagedProductDefinition.identifier [ Identifier ], ... ; # 0..* A unique identifier for this package as whole
  fhir:PackagedProductDefinition.name [ string ]; # 0..1 A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc
  fhir:PackagedProductDefinition.type [ CodeableConcept ]; # 0..1 A high level category e.g. medicinal product, raw material, shipping container etc
  fhir:PackagedProductDefinition.packageFor [ Reference(MedicinalProductDefinition) ], ... ; # 0..* The product that this is a pack for
  fhir:PackagedProductDefinition.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:PackagedProductDefinition.statusDate [ dateTime ]; # 0..1 The date at which the given status became applicable
  fhir:PackagedProductDefinition.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
  fhir:PackagedProductDefinition.description [ markdown ]; # 0..1 Textual description. Note that this is not the name of the package or product
  fhir:PackagedProductDefinition.legalStatusOfSupply [ # 0..* The legal status of supply of the packaged item as classified by the regulator
    fhir:PackagedProductDefinition.legalStatusOfSupply.code [ CodeableConcept ]; # 0..1 The actual status of supply. In what situation this package type may be supplied for use
    fhir:PackagedProductDefinition.legalStatusOfSupply.jurisdiction [ CodeableConcept ]; # 0..1 The place where the legal status of supply applies
  ], ...;
  fhir:PackagedProductDefinition.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:PackagedProductDefinition.characteristic [ CodeableConcept ], ... ; # 0..* Allows the key features to be recorded, such as "hospital pack", "nurse prescribable"
  fhir:PackagedProductDefinition.copackagedIndicator [ boolean ]; # 0..1 If the drug product is supplied with another item such as a diluent or adjuvant
  fhir:PackagedProductDefinition.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this package type (multiple means these are all possible manufacturers)
  fhir:PackagedProductDefinition.package [ # 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:PackagedProductDefinition.package.identifier [ Identifier ], ... ; # 0..* An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier
    fhir:PackagedProductDefinition.package.type [ CodeableConcept ]; # 0..1 The physical type of the container of the items
    fhir:PackagedProductDefinition.package.quantity [ integer ]; # 0..1 The quantity of this level of packaging in the package that contains it (with the outermost level being 1)
    fhir:PackagedProductDefinition.package.material [ CodeableConcept ], ... ; # 0..* Material type of the package item
    fhir:PackagedProductDefinition.package.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:PackagedProductDefinition.package.shelfLifeStorage [ # 0..* Shelf Life and storage information
      fhir:PackagedProductDefinition.package.shelfLifeStorage.type [ CodeableConcept ]; # 0..1 This describes the shelf life, taking into account various scenarios such as shelf life of the packaged Medicinal Product itself, shelf life after transformation where necessary and shelf life after the first opening of a bottle, etc. The shelf life type shall be specified using an appropriate controlled vocabulary The controlled term and the controlled term identifier shall be specified
      # PackagedProductDefinition.package.shelfLifeStorage.period[x] : 0..1 The shelf life time period can be specified using a numerical value for the period of time and its unit of time measurement The unit of measurement shall be specified in accordance with ISO 11240 and the resulting terminology The symbol and the symbol identifier shall be used. One of these 2
        fhir:PackagedProductDefinition.package.shelfLifeStorage.periodDuration [ Duration ]
        fhir:PackagedProductDefinition.package.shelfLifeStorage.periodString [ string ]
      fhir:PackagedProductDefinition.package.shelfLifeStorage.specialPrecautionsForStorage [ CodeableConcept ], ... ; # 0..* Special precautions for storage, if any, can be specified using an appropriate controlled vocabulary. The controlled term and the controlled term identifier shall be specified
    ], ...;
    fhir:PackagedProductDefinition.package.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this package Item (multiple means these are all possible manufacturers)
    fhir:PackagedProductDefinition.package.property [ # 0..* General characteristics of this item
      fhir:PackagedProductDefinition.package.property.type [ CodeableConcept ]; # 1..1 A code expressing the type of characteristic
      # PackagedProductDefinition.package.property.value[x] : 0..1 A value for the characteristic. One of these 5
        fhir:PackagedProductDefinition.package.property.valueCodeableConcept [ CodeableConcept ]
        fhir:PackagedProductDefinition.package.property.valueQuantity [ Quantity ]
        fhir:PackagedProductDefinition.package.property.valueDate [ date ]
        fhir:PackagedProductDefinition.package.property.valueBoolean [ boolean ]
        fhir:PackagedProductDefinition.package.property.valueAttachment [ Attachment ]
    ], ...;
    fhir:PackagedProductDefinition.package.containedItem [ # 0..* The item(s) within the packaging
      fhir:PackagedProductDefinition.package.containedItem.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:PackagedProductDefinition.package.containedItem.amount [ Quantity ]; # 0..1 The number of this type of item within this packaging
    ], ...;
    fhir:PackagedProductDefinition.package.package [ See PackagedProductDefinition.package ], ... ; # 0..* Allows containers (and parts of containers) within containers, still a single packaged product
  ];
]

Changes since Release 4

This resource did not exist in Release 3

This analysis is available as XML or JSON.

Conversions between R3 and R4

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis

15.2.3.1 Terminology Bindings

Path	Type	Reference
PackagedProductDefinition.type	Example	PackageType
PackagedProductDefinition.status	Preferred	PublicationStatus
PackagedProductDefinition.legalStatusOfSupply.code	Example	LegalStatusOfSupply
PackagedProductDefinition.legalStatusOfSupply.jurisdiction	Example	Jurisdiction ValueSet
PackagedProductDefinition.characteristic	Example	PackageCharacteristic
PackagedProductDefinition.package.type	Example	PackagingType
PackagedProductDefinition.package.material	Example	PackageMaterial
PackagedProductDefinition.package.alternateMaterial	Example	PackageMaterial
PackagedProductDefinition.package.property.type	Example	http://hl7.org/fhir/ValueSet/product-characteristic-codes

Path

Definition

Type

Reference

PackagedProductDefinition.type

Example

PackageType

PackagedProductDefinition.status

Preferred

PublicationStatus

PackagedProductDefinition.legalStatusOfSupply.code

Example

LegalStatusOfSupply

PackagedProductDefinition.legalStatusOfSupply.jurisdiction

Example

Jurisdiction ValueSet

PackagedProductDefinition.characteristic

Example

PackageCharacteristic

PackagedProductDefinition.package.type

Example

PackagingType

PackagedProductDefinition.package.material

Example

PackageMaterial

PackagedProductDefinition.package.alternateMaterial

Example

PackageMaterial

PackagedProductDefinition.package.property.type

Example

http://hl7.org/fhir/ValueSet/product-characteristic-codes

15.2.4 Search Parameters

Search parameters for 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 D	reference	A biologically derived product within this packaged product	PackagedProductDefinition.package.containedItem.item.reference
contained-item D	reference	Any of the contained items within this packaged product	PackagedProductDefinition.package.containedItem.item.reference
device D	reference	A device within this packaged product	PackagedProductDefinition.package.containedItem.item.reference
identifier	token	Unique identifier	PackagedProductDefinition.identifier
manufactured-item D	reference	A manufactured item of medication within this packaged product	PackagedProductDefinition.package.containedItem.item.reference
medication D	reference	A manufactured item of medication within this packaged product	PackagedProductDefinition.package.containedItem.item.reference
name N	token	A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc	PackagedProductDefinition.name
nutrition D	reference	A nutrition product within this packaged product	PackagedProductDefinition.package.containedItem.item.reference
package D	reference	A complete packaged product within this packaged product	PackagedProductDefinition.package.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