R4 Ballot #1 #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification ~~(v3.3.0:~~ (v3.5.0: R4 Ballot ~~2).~~ #2). 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 11.16 Resource MedicinalProductPackaged - Content

Biomedical Research and Regulation

Work Group

Maturity Level : 0

~~Draft~~ Trial Use

Compartments : Not linked to any defined compartments

A medicinal product in a container or package.

11.10.1 11.16.1 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~~ MedicinalProduct and MedicinalProductAuthorization

Structure

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

Name	Flags	Card.	Type	Description & Constraints
MedicinalProductPackaged	Σ D TU		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
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
~~manufacturer Σ 0..* Reference ( Organization ) Manufacturer of this Package Item~~ device	Σ	0..*	Reference ( MedicinalProductDeviceSpec \| DeviceDefinition )	A device accompanying a medicinal product
manufacturedItem	Σ	0..*	~~BackboneElement~~ Reference ( MedicinalProductManufactured )	The manufactured item as contained in the packaged medicinal product
~~xManufacturer~~ packageItem	Σ	0..*	~~Reference ( Organization ) Manufacturer of the item (Note that this should be named "manufacturer" but it currently causes technical issues) ingredient Σ~~ see packageItem	~~0..* Reference ( MedicinalProductIngredient ) Ingredient~~ Allows containers within containers
physicalCharacteristics	Σ	0..1	ProdCharacteristic	Dimensions, color etc.
otherCharacteristics	Σ	0..*	CodeableConcept	Other codeable characteristics
~~packageItem~~ shelfLifeStorage	Σ	0..*	~~see packageItem Allows containers within containers~~ ~~physicalCharacteristics Σ~~ ProductShelfLife	~~0..1 ProdCharacteristic~~ Shelf Life and storage information ~~Dimensions, color etc.~~
~~shelfLifeStorage~~ manufacturer	Σ	0..*	~~ProductShelfLife~~ Reference ( Organization )	~~Shelf Life and storage information~~ 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><!-- 1..1 Identifier Unique identifier --></identifier>
 <description value="[string]"/><!-- 0..1 Textual description -->
 <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>
  <</manufacturer>
  <</device>
  <
   <</manufacturedDoseForm>
   <</unitOfPresentation>
   <</quantity>
   <</xManufacturer>
   <</ingredient>
   <</physicalCharacteristics>
  </manufacturedItem>
  <</otherCharacteristics>

  <device><!-- 0..* Reference(MedicinalProductDeviceSpec|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 }, // R!  Unique identifier
  "description" : "<string>", // Textual description
  "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(MedicinalProductDeviceSpec|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 ]; # 1..1 Unique identifier
  fhir:MedicinalProductPackaged.description [ string ]; # 0..1 Textual description
  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:
    fhir:
    fhir:
      fhir:
      fhir:
      fhir:
      fhir:
      fhir:
      fhir:
    ], ...;
    fhir:

    fhir:MedicinalProductPackaged.packageItem.device [ Reference(MedicinalProductDeviceSpec|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 .

See R3 <--> R4 Conversion Maps (status = Not Mapped)