This page is part of the FHIR Specification (v4.0.1: R4 - Mixed Normative and STU) in it's permanent home (it will always be available at this URL). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

11.19 Resource MedicinalProductPackaged - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Trial Use

Security Category: Anonymous

Compartments: Not linked to any defined compartments

A medicinal product in a container or package.

11.19.1 Scope and Usage

This resource is still undergoing development and review by the appropriate Workgroups. At this time, is considered only as a draft resource not suitable for production implementation

Medicinal Product in a container being part of a package, representing the entirety that has been packaged for sale or supply

This resource is referenced by MedicinalProduct and MedicinalProductAuthorization

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductPackaged	Σ TU		DomainResource	A medicinal product in a container or package Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Unique identifier
subject	Σ	0..*	Reference(MedicinalProduct)	The product with this is a pack for
description	Σ	0..1	string	Textual description
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator
marketingStatus	Σ	0..*	MarketingStatus	Marketing information
marketingAuthorization	Σ	0..1	Reference(MedicinalProductAuthorization)	Manufacturer of this Package Item
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this Package Item
batchIdentifier	Σ	0..*	BackboneElement	Batch numbering
outerPackaging	Σ	1..1	Identifier	A number appearing on the outer packaging of a specific batch
immediatePackaging	Σ	0..1	Identifier	A number appearing on the immediate packaging (and not the outer packaging)
packageItem	Σ	1..*	BackboneElement	A packaging item, as a contained for medicine, possibly with other packaging items within
identifier	Σ	0..*	Identifier	Including possibly Data Carrier Identifier
type	Σ	1..1	CodeableConcept	The physical type of the container of the medicine
quantity	Σ	1..1	Quantity	The quantity of this package in the medicinal product, at the current level of packaging. The outermost is always 1
material	Σ	0..*	CodeableConcept	Material type of the package item
alternateMaterial	Σ	0..*	CodeableConcept	A possible alternate material for the packaging
device	Σ	0..*	Reference(DeviceDefinition)	A device accompanying a medicinal product
manufacturedItem	Σ	0..*	Reference(MedicinalProductManufactured)	The manufactured item as contained in the packaged medicinal product
packageItem	Σ	0..*	see packageItem	Allows containers within containers
physicalCharacteristics	Σ	0..1	ProdCharacteristic	Dimensions, color etc.
otherCharacteristics	Σ	0..*	CodeableConcept	Other codeable characteristics
shelfLifeStorage	Σ	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this Package Item
Documentation for this format

UML Diagram (Legend)

XML Template

<MedicinalProductPackaged xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Unique identifier --></identifier>
 <subject><!-- 0..* Reference(MedicinalProduct) The product with this is a pack for --></subject>
 <description value="[string]"/><!-- 0..1 Textual description -->
 <legalStatusOfSupply><!-- 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator --></legalStatusOfSupply>
 <marketingStatus><!-- 0..* MarketingStatus Marketing information --></marketingStatus>
 <marketingAuthorization><!-- 0..1 Reference(MedicinalProductAuthorization) Manufacturer of this Package Item --></marketingAuthorization>
 <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this Package Item --></manufacturer>
 <batchIdentifier>  <!-- 0..* Batch numbering -->
  <outerPackaging><!-- 1..1 Identifier A number appearing on the outer packaging of a specific batch --></outerPackaging>
  <immediatePackaging><!-- 0..1 Identifier A number appearing on the immediate packaging (and not the outer packaging) --></immediatePackaging>
 </batchIdentifier>
 <packageItem>  <!-- 1..* A packaging item, as a contained for medicine, possibly with other packaging items within -->
  <identifier><!-- 0..* Identifier Including possibly Data Carrier Identifier --></identifier>
  <type><!-- 1..1 CodeableConcept The physical type of the container of the medicine --></type>
  <quantity><!-- 1..1 Quantity The quantity of this package in the medicinal product, at the current level of packaging. The outermost is always 1 --></quantity>
  <material><!-- 0..* CodeableConcept Material type of the package item --></material>
  <alternateMaterial><!-- 0..* CodeableConcept A possible alternate material for the packaging --></alternateMaterial>
  <device><!-- 0..* Reference(DeviceDefinition) A device accompanying a medicinal product --></device>
  <manufacturedItem><!-- 0..* Reference(MedicinalProductManufactured) The manufactured item as contained in the packaged medicinal product --></manufacturedItem>
  <packageItem><!-- 0..* Content as for MedicinalProductPackaged.packageItem Allows containers within containers --></packageItem>
  <physicalCharacteristics><!-- 0..1 ProdCharacteristic Dimensions, color etc. --></physicalCharacteristics>
  <otherCharacteristics><!-- 0..* CodeableConcept Other codeable characteristics --></otherCharacteristics>
  <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
  <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this Package Item --></manufacturer>
 </packageItem>
</MedicinalProductPackaged>

JSON Template

{
  "resourceType" : "MedicinalProductPackaged",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Unique identifier
  "subject" : [{ Reference(MedicinalProduct) }], // The product with this is a pack for
  "description" : "<string>", // Textual description
  "legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply of the medicinal product as classified by the regulator
  "marketingStatus" : [{ MarketingStatus }], // Marketing information
  "marketingAuthorization" : { Reference(MedicinalProductAuthorization) }, // Manufacturer of this Package Item
  "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this Package Item
  "batchIdentifier" : [{ // Batch numbering
    "outerPackaging" : { Identifier }, // R!  A number appearing on the outer packaging of a specific batch
    "immediatePackaging" : { Identifier } // A number appearing on the immediate packaging (and not the outer packaging)
  }],
  "packageItem" : [{ // R!  A packaging item, as a contained for medicine, possibly with other packaging items within
    "identifier" : [{ Identifier }], // Including possibly Data Carrier Identifier
    "type" : { CodeableConcept }, // R!  The physical type of the container of the medicine
    "quantity" : { Quantity }, // R!  The quantity of this package in the medicinal product, at the current level of packaging. The outermost is always 1
    "material" : [{ CodeableConcept }], // Material type of the package item
    "alternateMaterial" : [{ CodeableConcept }], // A possible alternate material for the packaging
    "device" : [{ Reference(DeviceDefinition) }], // A device accompanying a medicinal product
    "manufacturedItem" : [{ Reference(MedicinalProductManufactured) }], // The manufactured item as contained in the packaged medicinal product
    "packageItem" : [{ Content as for MedicinalProductPackaged.packageItem }], // Allows containers within containers
    "physicalCharacteristics" : { ProdCharacteristic }, // Dimensions, color etc.
    "otherCharacteristics" : [{ CodeableConcept }], // Other codeable characteristics
    "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
    "manufacturer" : [{ Reference(Organization) }] // Manufacturer of this Package Item
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:MedicinalProductPackaged;
  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:MedicinalProductPackaged.identifier [ Identifier ], ... ; # 0..* Unique identifier
  fhir:MedicinalProductPackaged.subject [ Reference(MedicinalProduct) ], ... ; # 0..* The product with this is a pack for
  fhir:MedicinalProductPackaged.description [ string ]; # 0..1 Textual description
  fhir:MedicinalProductPackaged.legalStatusOfSupply [ CodeableConcept ]; # 0..1 The legal status of supply of the medicinal product as classified by the regulator
  fhir:MedicinalProductPackaged.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing information
  fhir:MedicinalProductPackaged.marketingAuthorization [ Reference(MedicinalProductAuthorization) ]; # 0..1 Manufacturer of this Package Item
  fhir:MedicinalProductPackaged.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this Package Item
  fhir:MedicinalProductPackaged.batchIdentifier [ # 0..* Batch numbering
    fhir:MedicinalProductPackaged.batchIdentifier.outerPackaging [ Identifier ]; # 1..1 A number appearing on the outer packaging of a specific batch
    fhir:MedicinalProductPackaged.batchIdentifier.immediatePackaging [ Identifier ]; # 0..1 A number appearing on the immediate packaging (and not the outer packaging)
  ], ...;
  fhir:MedicinalProductPackaged.packageItem [ # 1..* A packaging item, as a contained for medicine, possibly with other packaging items within
    fhir:MedicinalProductPackaged.packageItem.identifier [ Identifier ], ... ; # 0..* Including possibly Data Carrier Identifier
    fhir:MedicinalProductPackaged.packageItem.type [ CodeableConcept ]; # 1..1 The physical type of the container of the medicine
    fhir:MedicinalProductPackaged.packageItem.quantity [ Quantity ]; # 1..1 The quantity of this package in the medicinal product, at the current level of packaging. The outermost is always 1
    fhir:MedicinalProductPackaged.packageItem.material [ CodeableConcept ], ... ; # 0..* Material type of the package item
    fhir:MedicinalProductPackaged.packageItem.alternateMaterial [ CodeableConcept ], ... ; # 0..* A possible alternate material for the packaging
    fhir:MedicinalProductPackaged.packageItem.device [ Reference(DeviceDefinition) ], ... ; # 0..* A device accompanying a medicinal product
    fhir:MedicinalProductPackaged.packageItem.manufacturedItem [ Reference(MedicinalProductManufactured) ], ... ; # 0..* The manufactured item as contained in the packaged medicinal product
    fhir:MedicinalProductPackaged.packageItem.packageItem [ See MedicinalProductPackaged.packageItem ], ... ; # 0..* Allows containers within containers
    fhir:MedicinalProductPackaged.packageItem.physicalCharacteristics [ ProdCharacteristic ]; # 0..1 Dimensions, color etc.
    fhir:MedicinalProductPackaged.packageItem.otherCharacteristics [ CodeableConcept ], ... ; # 0..* Other codeable characteristics
    fhir:MedicinalProductPackaged.packageItem.shelfLifeStorage [ ProductShelfLife ], ... ; # 0..* Shelf Life and storage information
    fhir:MedicinalProductPackaged.packageItem.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this Package Item
  ], ...;
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductPackaged	Σ TU		DomainResource	A medicinal product in a container or package Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Unique identifier
subject	Σ	0..*	Reference(MedicinalProduct)	The product with this is a pack for
description	Σ	0..1	string	Textual description
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator
marketingStatus	Σ	0..*	MarketingStatus	Marketing information
marketingAuthorization	Σ	0..1	Reference(MedicinalProductAuthorization)	Manufacturer of this Package Item
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this Package Item
batchIdentifier	Σ	0..*	BackboneElement	Batch numbering
outerPackaging	Σ	1..1	Identifier	A number appearing on the outer packaging of a specific batch
immediatePackaging	Σ	0..1	Identifier	A number appearing on the immediate packaging (and not the outer packaging)
packageItem	Σ	1..*	BackboneElement	A packaging item, as a contained for medicine, possibly with other packaging items within
identifier	Σ	0..*	Identifier	Including possibly Data Carrier Identifier
type	Σ	1..1	CodeableConcept	The physical type of the container of the medicine
quantity	Σ	1..1	Quantity	The quantity of this package in the medicinal product, at the current level of packaging. The outermost is always 1
material	Σ	0..*	CodeableConcept	Material type of the package item
alternateMaterial	Σ	0..*	CodeableConcept	A possible alternate material for the packaging
device	Σ	0..*	Reference(DeviceDefinition)	A device accompanying a medicinal product
manufacturedItem	Σ	0..*	Reference(MedicinalProductManufactured)	The manufactured item as contained in the packaged medicinal product
packageItem	Σ	0..*	see packageItem	Allows containers within containers
physicalCharacteristics	Σ	0..1	ProdCharacteristic	Dimensions, color etc.
otherCharacteristics	Σ	0..*	CodeableConcept	Other codeable characteristics
shelfLifeStorage	Σ	0..*	ProductShelfLife	Shelf Life and storage information
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this Package Item
Documentation for this format

UML Diagram (Legend)

XML Template

<MedicinalProductPackaged xmlns="http://hl7.org/fhir"> 
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Unique identifier --></identifier>
 <subject><!-- 0..* Reference(MedicinalProduct) The product with this is a pack for --></subject>
 <description value="[string]"/><!-- 0..1 Textual description -->
 <legalStatusOfSupply><!-- 0..1 CodeableConcept The legal status of supply of the medicinal product as classified by the regulator --></legalStatusOfSupply>
 <marketingStatus><!-- 0..* MarketingStatus Marketing information --></marketingStatus>
 <marketingAuthorization><!-- 0..1 Reference(MedicinalProductAuthorization) Manufacturer of this Package Item --></marketingAuthorization>
 <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this Package Item --></manufacturer>
 <batchIdentifier>  <!-- 0..* Batch numbering -->
  <outerPackaging><!-- 1..1 Identifier A number appearing on the outer packaging of a specific batch --></outerPackaging>
  <immediatePackaging><!-- 0..1 Identifier A number appearing on the immediate packaging (and not the outer packaging) --></immediatePackaging>
 </batchIdentifier>
 <packageItem>  <!-- 1..* A packaging item, as a contained for medicine, possibly with other packaging items within -->
  <identifier><!-- 0..* Identifier Including possibly Data Carrier Identifier --></identifier>
  <type><!-- 1..1 CodeableConcept The physical type of the container of the medicine --></type>
  <quantity><!-- 1..1 Quantity The quantity of this package in the medicinal product, at the current level of packaging. The outermost is always 1 --></quantity>
  <material><!-- 0..* CodeableConcept Material type of the package item --></material>
  <alternateMaterial><!-- 0..* CodeableConcept A possible alternate material for the packaging --></alternateMaterial>
  <device><!-- 0..* Reference(DeviceDefinition) A device accompanying a medicinal product --></device>
  <manufacturedItem><!-- 0..* Reference(MedicinalProductManufactured) The manufactured item as contained in the packaged medicinal product --></manufacturedItem>
  <packageItem><!-- 0..* Content as for MedicinalProductPackaged.packageItem Allows containers within containers --></packageItem>
  <physicalCharacteristics><!-- 0..1 ProdCharacteristic Dimensions, color etc. --></physicalCharacteristics>
  <otherCharacteristics><!-- 0..* CodeableConcept Other codeable characteristics --></otherCharacteristics>
  <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
  <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this Package Item --></manufacturer>
 </packageItem>
</MedicinalProductPackaged>

JSON Template

{
  "resourceType" : "MedicinalProductPackaged",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Unique identifier
  "subject" : [{ Reference(MedicinalProduct) }], // The product with this is a pack for
  "description" : "<string>", // Textual description
  "legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply of the medicinal product as classified by the regulator
  "marketingStatus" : [{ MarketingStatus }], // Marketing information
  "marketingAuthorization" : { Reference(MedicinalProductAuthorization) }, // Manufacturer of this Package Item
  "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this Package Item
  "batchIdentifier" : [{ // Batch numbering
    "outerPackaging" : { Identifier }, // R!  A number appearing on the outer packaging of a specific batch
    "immediatePackaging" : { Identifier } // A number appearing on the immediate packaging (and not the outer packaging)
  }],
  "packageItem" : [{ // R!  A packaging item, as a contained for medicine, possibly with other packaging items within
    "identifier" : [{ Identifier }], // Including possibly Data Carrier Identifier
    "type" : { CodeableConcept }, // R!  The physical type of the container of the medicine
    "quantity" : { Quantity }, // R!  The quantity of this package in the medicinal product, at the current level of packaging. The outermost is always 1
    "material" : [{ CodeableConcept }], // Material type of the package item
    "alternateMaterial" : [{ CodeableConcept }], // A possible alternate material for the packaging
    "device" : [{ Reference(DeviceDefinition) }], // A device accompanying a medicinal product
    "manufacturedItem" : [{ Reference(MedicinalProductManufactured) }], // The manufactured item as contained in the packaged medicinal product
    "packageItem" : [{ Content as for MedicinalProductPackaged.packageItem }], // Allows containers within containers
    "physicalCharacteristics" : { ProdCharacteristic }, // Dimensions, color etc.
    "otherCharacteristics" : [{ CodeableConcept }], // Other codeable characteristics
    "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
    "manufacturer" : [{ Reference(Organization) }] // Manufacturer of this Package Item
  }]
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .


[ a fhir:MedicinalProductPackaged;
  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:MedicinalProductPackaged.identifier [ Identifier ], ... ; # 0..* Unique identifier
  fhir:MedicinalProductPackaged.subject [ Reference(MedicinalProduct) ], ... ; # 0..* The product with this is a pack for
  fhir:MedicinalProductPackaged.description [ string ]; # 0..1 Textual description
  fhir:MedicinalProductPackaged.legalStatusOfSupply [ CodeableConcept ]; # 0..1 The legal status of supply of the medicinal product as classified by the regulator
  fhir:MedicinalProductPackaged.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing information
  fhir:MedicinalProductPackaged.marketingAuthorization [ Reference(MedicinalProductAuthorization) ]; # 0..1 Manufacturer of this Package Item
  fhir:MedicinalProductPackaged.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this Package Item
  fhir:MedicinalProductPackaged.batchIdentifier [ # 0..* Batch numbering
    fhir:MedicinalProductPackaged.batchIdentifier.outerPackaging [ Identifier ]; # 1..1 A number appearing on the outer packaging of a specific batch
    fhir:MedicinalProductPackaged.batchIdentifier.immediatePackaging [ Identifier ]; # 0..1 A number appearing on the immediate packaging (and not the outer packaging)
  ], ...;
  fhir:MedicinalProductPackaged.packageItem [ # 1..* A packaging item, as a contained for medicine, possibly with other packaging items within
    fhir:MedicinalProductPackaged.packageItem.identifier [ Identifier ], ... ; # 0..* Including possibly Data Carrier Identifier
    fhir:MedicinalProductPackaged.packageItem.type [ CodeableConcept ]; # 1..1 The physical type of the container of the medicine
    fhir:MedicinalProductPackaged.packageItem.quantity [ Quantity ]; # 1..1 The quantity of this package in the medicinal product, at the current level of packaging. The outermost is always 1
    fhir:MedicinalProductPackaged.packageItem.material [ CodeableConcept ], ... ; # 0..* Material type of the package item
    fhir:MedicinalProductPackaged.packageItem.alternateMaterial [ CodeableConcept ], ... ; # 0..* A possible alternate material for the packaging
    fhir:MedicinalProductPackaged.packageItem.device [ Reference(DeviceDefinition) ], ... ; # 0..* A device accompanying a medicinal product
    fhir:MedicinalProductPackaged.packageItem.manufacturedItem [ Reference(MedicinalProductManufactured) ], ... ; # 0..* The manufactured item as contained in the packaged medicinal product
    fhir:MedicinalProductPackaged.packageItem.packageItem [ See MedicinalProductPackaged.packageItem ], ... ; # 0..* Allows containers within containers
    fhir:MedicinalProductPackaged.packageItem.physicalCharacteristics [ ProdCharacteristic ]; # 0..1 Dimensions, color etc.
    fhir:MedicinalProductPackaged.packageItem.otherCharacteristics [ CodeableConcept ], ... ; # 0..* Other codeable characteristics
    fhir:MedicinalProductPackaged.packageItem.shelfLifeStorage [ ProductShelfLife ], ... ; # 0..* Shelf Life and storage information
    fhir:MedicinalProductPackaged.packageItem.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this Package Item
  ], ...;
]

Changes since Release 3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

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

11.19.3 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
identifier	token	Unique identifier	MedicinalProductPackaged.identifier
subject	reference	The product with this is a pack for	MedicinalProductPackaged.subject (MedicinalProduct)