This page is part of the FHIR Specification (v3.2.0: R4 Ballot 1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

11.10 Resource MedicinalProductPackaged - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Draft

Compartments: Not linked to any defined compartments

A medicinal product in a container or package.

11.10.1 Scope and Usage

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

Structure

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductPackaged	Σ D		DomainResource	A medicinal product in a container or package Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	1..1	Identifier	Unique identifier
description	Σ	0..1	string	Textual description
marketingStatus	Σ	0..*	MarketingStatus	Marketing information
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
manufacturer	Σ	0..*	Reference(Organization)	Manufacturer of this Package Item
device	Σ	0..*	Reference(MedicinalProductDeviceSpec)	A device accompanying a medicinal product
manufacturedItem	Σ	0..*	BackboneElement	The manufactured item as contained in the packaged medicinal product
manufacturedDoseForm	Σ	1..1	CodeableConcept	Dose form as manufactured and before any transformation into the pharmaceutical product
unitOfPresentation	Σ	0..1	CodeableConcept	The “real world” units in which the quantity of the manufactured item is described
quantity	Σ	1..1	Quantity	The quantity or "count number" of the manufactured item
xManufacturer	Σ	0..*	Reference(Organization)	Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
ingredient	Σ	0..*	Reference(MedicinalProductIngredient)	Ingredient
physicalCharacteristics	Σ	0..1	ProdCharacteristic	Dimensions, color etc
otherCharacteristics	Σ	0..*	CodeableConcept	Other codeable characteristics
packageItem	Σ	0..*	see packageItem	Allows containers within containers
physicalCharacteristics	Σ	0..1	ProdCharacteristic	Dimensions, color etc
shelfLifeStorage	Σ	0..*	ProductShelfLife	Shelf Life and storage information
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><!-- 1..1 Identifier Unique identifier --></identifier>
 <description value="[string]"/><!-- 0..1 Textual description -->
 <marketingStatus><!-- 0..* MarketingStatus Marketing information --></marketingStatus>
 <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>
  <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this Package Item --></manufacturer>
  <device><!-- 0..* Reference(MedicinalProductDeviceSpec) A device accompanying a medicinal product --></device>
  <manufacturedItem>  <!-- 0..* The manufactured item as contained in the packaged medicinal product -->
   <manufacturedDoseForm><!-- 1..1 CodeableConcept Dose form as manufactured and before any transformation into the pharmaceutical product --></manufacturedDoseForm>
   <unitOfPresentation><!-- 0..1 CodeableConcept The “real world” units in which the quantity of the manufactured item is described --></unitOfPresentation>
   <quantity><!-- 1..1 Quantity The quantity or "count number" of the manufactured item --></quantity>
   <xManufacturer><!-- 0..* Reference(Organization) Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues) --></xManufacturer>
   <ingredient><!-- 0..* Reference(MedicinalProductIngredient) Ingredient --></ingredient>
   <physicalCharacteristics><!-- 0..1 ProdCharacteristic Dimensions, color etc --></physicalCharacteristics>
  </manufacturedItem>
  <otherCharacteristics><!-- 0..* CodeableConcept Other codeable characteristics --></otherCharacteristics>
  <packageItem><!-- 0..* Content as for MedicinalProductPackaged.packageItem Allows containers within containers --></packageItem>
  <physicalCharacteristics><!-- 0..1 ProdCharacteristic Dimensions, color etc --></physicalCharacteristics>
  <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
 </packageItem>
</MedicinalProductPackaged>

JSON Template

{
  "resourceType" : "MedicinalProductPackaged",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : { Identifier }, // R!  Unique identifier
  "description" : "<string>", // Textual description
  "marketingStatus" : [{ MarketingStatus }], // Marketing information
  "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
    "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this Package Item
    "device" : [{ Reference(MedicinalProductDeviceSpec) }], // A device accompanying a medicinal product
    "manufacturedItem" : [{ // The manufactured item as contained in the packaged medicinal product
      "manufacturedDoseForm" : { CodeableConcept }, // R!  Dose form as manufactured and before any transformation into the pharmaceutical product
      "unitOfPresentation" : { CodeableConcept }, // The “real world” units in which the quantity of the manufactured item is described
      "quantity" : { Quantity }, // R!  The quantity or "count number" of the manufactured item
      "xManufacturer" : [{ Reference(Organization) }], // Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
      "ingredient" : [{ Reference(MedicinalProductIngredient) }], // Ingredient
      "physicalCharacteristics" : { ProdCharacteristic } // Dimensions, color etc
    }],
    "otherCharacteristics" : [{ CodeableConcept }], // Other codeable characteristics
    "packageItem" : [{ Content as for MedicinalProductPackaged.packageItem }], // Allows containers within containers
    "physicalCharacteristics" : { ProdCharacteristic }, // Dimensions, color etc
    "shelfLifeStorage" : [{ ProductShelfLife }] // Shelf Life and storage information
  }]
}

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 ]; # 1..1 Unique identifier
  fhir:MedicinalProductPackaged.description [ string ]; # 0..1 Textual description
  fhir:MedicinalProductPackaged.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing information
  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.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this Package Item
    fhir:MedicinalProductPackaged.packageItem.device [ Reference(MedicinalProductDeviceSpec) ], ... ; # 0..* A device accompanying a medicinal product
    fhir:MedicinalProductPackaged.packageItem.manufacturedItem [ # 0..* The manufactured item as contained in the packaged medicinal product
      fhir:MedicinalProductPackaged.packageItem.manufacturedItem.manufacturedDoseForm [ CodeableConcept ]; # 1..1 Dose form as manufactured and before any transformation into the pharmaceutical product
      fhir:MedicinalProductPackaged.packageItem.manufacturedItem.unitOfPresentation [ CodeableConcept ]; # 0..1 The “real world” units in which the quantity of the manufactured item is described
      fhir:MedicinalProductPackaged.packageItem.manufacturedItem.quantity [ Quantity ]; # 1..1 The quantity or "count number" of the manufactured item
      fhir:MedicinalProductPackaged.packageItem.manufacturedItem.xManufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues)
      fhir:MedicinalProductPackaged.packageItem.manufacturedItem.ingredient [ Reference(MedicinalProductIngredient) ], ... ; # 0..* Ingredient
      fhir:MedicinalProductPackaged.packageItem.manufacturedItem.physicalCharacteristics [ ProdCharacteristic ]; # 0..1 Dimensions, color etc
    ], ...;
    fhir:MedicinalProductPackaged.packageItem.otherCharacteristics [ CodeableConcept ], ... ; # 0..* Other codeable characteristics
    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.shelfLifeStorage [ ProductShelfLife ], ... ; # 0..* Shelf Life and storage information
  ], ...;
]

Changes since DSTU2

This resource did not exist in Release 2

This analysis is available as XML or JSON.