Release 5 Preview #2

This page is part of the FHIR Specification (v4.4.0: R5 Preview #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 . Page versions: R5 R4B

11.12 Resource PackagedProductDefinition - Content

Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

A medicinal product in a container or package.

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 MedicinalProductDefinition and RegulatedAuthorization.

This resource does not implement any patterns.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition ΣTUDomainResourceA medicinal product in a container or package
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierUnique identifier
... name Σ0..1stringA name for this product pack. Typically what it would be listed as in a drug formulary
... subject Σ0..*Reference(MedicinalProductDefinition)The product that this is a pack for
... statusDate Σ0..1dateTimeThe date at which the given status became applicable
... description Σ0..1markdownTextual description. Note that this is not the name of the product
... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator
... marketingStatus Σ0..*MarketingStatusMarketing information
... characteristic Σ0..*CodeableConceptAllows the key product features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"
... copackagedIndicator Σ0..1booleanStates whether a drug product is supplied with another item such as a diluent or adjuvant
... marketingAuthorization Σ0..1Reference(RegulatedAuthorization)Manufacturer of this Package Item
... manufacturer Σ0..*Reference(Organization)Manufacturer of this Package Item
... batchIdentifier Σ0..*BackboneElementBatch numbering
.... outerPackaging Σ1..1IdentifierA number appearing on the outer packaging of a specific batch
.... immediatePackaging Σ0..1IdentifierA number appearing on the immediate packaging (and not the outer packaging)
... package Σ0..*BackboneElementA packaging item, as a contained for medicine, possibly with other packaging items within
.... identifier Σ0..*IdentifierIncluding possibly Data Carrier Identifier
.... type Σ0..1CodeableConceptThe physical type of the container of the medicine
.... quantity Σ0..1integerThe quantity of this package in the medicinal product, at the current level of packaging. If specified, the outermost level is always 1
.... material Σ0..*CodeableConceptMaterial type of the package item
.... alternateMaterial Σ0..*CodeableConceptA possible alternate material for the packaging
.... shelfLifeStorage Σ0..*ProductShelfLifeShelf Life and storage information
.... manufacturer Σ0..*Reference(Organization)Manufacturer of this Package Item
.... property Σ0..*BackboneElementGeneral characteristics of this item
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
..... value[x] Σ0..1A value for the characteristic
...... valueCodeableConceptCodeableConcept
...... valueQuantityQuantity
...... valueDatedate
...... valueBooleanboolean
...... valueAttachmentAttachment
.... containedItem Σ0..*BackboneElementThe item(s) within the packaging
..... item Σ0..*Reference(ManufacturedItemDefinition | DeviceDefinition)The manufactured item or device as contained in the packaged medicinal product
..... amount[x] Σ0..1The number of this type of item within this packaging
...... amountQuantityQuantity
...... amountIntegerinteger
.... package Σ0..*see packageAllows containers within containers

doco Documentation for this format

UML Diagram (Legend)

PackagedProductDefinition (DomainResource)Unique identifieridentifier : Identifier [0..*]A name for this product pack. Typically what it would be listed as in a drug formularyname : string [0..1]The product that this is a pack forsubject : Reference [0..*] « MedicinalProductDefinition »The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization or marketing statusstatus : CodeableConcept [0..1] « Identifies the level of importance to be assigned to actioning the request. (Strength=Preferred)PublicationStatus? »The date at which the given status became applicablestatusDate : dateTime [0..1]Textual description. Note that this is not the name of the productdescription : markdown [0..1]The legal status of supply of the medicinal product as classified by the regulatorlegalStatusOfSupply : CodeableConcept [0..1]Marketing informationmarketingStatus : MarketingStatus [0..*]Allows the key product features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"characteristic : CodeableConcept [0..*]States whether a drug product is supplied with another item such as a diluent or adjuvantcopackagedIndicator : boolean [0..1]Manufacturer of this Package ItemmarketingAuthorization : Reference [0..1] « RegulatedAuthorization »Manufacturer of this Package Itemmanufacturer : Reference [0..*] « Organization »BatchIdentifierA number appearing on the outer packaging of a specific batchouterPackaging : Identifier [1..1]A number appearing on the immediate packaging (and not the outer packaging)immediatePackaging : Identifier [0..1]PackageIncluding possibly Data Carrier Identifieridentifier : Identifier [0..*]The physical type of the container of the medicinetype : CodeableConcept [0..1]The quantity of this package in the medicinal product, at the current level of packaging. If specified, the outermost level is always 1quantity : integer [0..1]Material type of the package itemmaterial : CodeableConcept [0..*]A possible alternate material for the packagingalternateMaterial : CodeableConcept [0..*]Shelf Life and storage informationshelfLifeStorage : ProductShelfLife [0..*]Manufacturer of this Package Itemmanufacturer : Reference [0..*] « Organization »PropertyA code expressing the type of characteristictype : CodeableConcept [1..1]A value for the characteristicvalue[x] : DataType [0..1] « CodeableConcept|Quantity|date|boolean| Attachment »ContainedItemThe manufactured item or device as contained in the packaged medicinal productitem : Reference [0..*] « ManufacturedItemDefinition| DeviceDefinition »The number of this type of item within this packagingamount[x] : DataType [0..1] « Quantity|integer »Batch numberingbatchIdentifier[0..*]General characteristics of this itemproperty[0..*]The item(s) within the packagingcontainedItem[0..*]Allows containers within containerspackage[0..*]A packaging item, as a contained for medicine, possibly with other packaging items withinpackage[0..*]

XML Template

<PackagedProductDefinition xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Unique identifier --></identifier>
 <name value="[string]"/><!-- 0..1 A name for this product pack. Typically what it would be listed as in a drug formulary -->
 <subject><!-- 0..* Reference(MedicinalProductDefinition) The product that this is a pack for --></subject>
 <status><!-- 0..1 CodeableConcept The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization or marketing status --></status>
 <statusDate value="[dateTime]"/><!-- 0..1 The date at which the given status became applicable -->
 <description value="[markdown]"/><!-- 0..1 Textual description. Note that this is not the name of the product -->
 <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>
 <characteristic><!-- 0..* CodeableConcept Allows the key product features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack" --></characteristic>
 <copackagedIndicator value="[boolean]"/><!-- 0..1 States whether a drug product is supplied with another item such as a diluent or adjuvant -->
 <marketingAuthorization><!-- 0..1 Reference(RegulatedAuthorization) 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>
 <package>  <!-- 0..* A packaging item, as a contained for medicine, possibly with other packaging items within -->
  <identifier><!-- 0..* Identifier Including possibly Data Carrier Identifier --></identifier>
  <type><!-- 0..1 CodeableConcept The physical type of the container of the medicine --></type>
  <quantity value="[integer]"/><!-- 0..1 The quantity of this package in the medicinal product, at the current level of packaging. If specified, the outermost level is always 1 -->
  <material><!-- 0..* CodeableConcept Material type of the package item --></material>
  <alternateMaterial><!-- 0..* CodeableConcept A possible alternate material for the packaging --></alternateMaterial>
  <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
  <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this Package Item --></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><!-- 0..* Reference(DeviceDefinition|ManufacturedItemDefinition) The manufactured item or device as contained in the packaged medicinal product --></item>
   <amount[x]><!-- 0..1 Quantity|integer The number of this type of item within this packaging --></amount[x]>
  </containedItem>
  <package><!-- 0..* Content as for PackagedProductDefinition.package Allows containers within containers --></package>
 </package>
</PackagedProductDefinition>

JSON Template

{doco
  "resourceType" : "PackagedProductDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Unique identifier
  "name" : "<string>", // A name for this product pack. Typically what it would be listed as in a drug formulary
  "subject" : [{ Reference(MedicinalProductDefinition) }], // The product that this is a pack for
  "status" : { CodeableConcept }, // The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization or marketing status
  "statusDate" : "<dateTime>", // The date at which the given status became applicable
  "description" : "<markdown>", // Textual description. Note that this is not the name of the product
  "legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply of the medicinal product as classified by the regulator
  "marketingStatus" : [{ MarketingStatus }], // Marketing information
  "characteristic" : [{ CodeableConcept }], // Allows the key product features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"
  "copackagedIndicator" : <boolean>, // States whether a drug product is supplied with another item such as a diluent or adjuvant
  "marketingAuthorization" : { Reference(RegulatedAuthorization) }, // 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)
  }],
  "package" : [{ // A packaging item, as a contained for medicine, possibly with other packaging items within
    "identifier" : [{ Identifier }], // Including possibly Data Carrier Identifier
    "type" : { CodeableConcept }, // The physical type of the container of the medicine
    "quantity" : <integer>, // The quantity of this package in the medicinal product, at the current level of packaging. If specified, the outermost level is always 1
    "material" : [{ CodeableConcept }], // Material type of the package item
    "alternateMaterial" : [{ CodeableConcept }], // A possible alternate material for the packaging
    "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
    "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this Package Item
    "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" : [{ Reference(DeviceDefinition|ManufacturedItemDefinition) }], // The manufactured item or device as contained in the packaged medicinal product
      // amount[x]: The number of this type of item within this packaging. One of these 2:
      "amountQuantity" : { Quantity }
      "amountInteger" : <integer>
    }],
    "package" : [{ Content as for PackagedProductDefinition.package }] // Allows containers within containers
  }]
}

Turtle Template

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


[ 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..* Unique identifier
  fhir:PackagedProductDefinition.name [ string ]; # 0..1 A name for this product pack. Typically what it would be listed as in a drug formulary
  fhir:PackagedProductDefinition.subject [ Reference(MedicinalProductDefinition) ], ... ; # 0..* The product that this is a pack for
  fhir:PackagedProductDefinition.status [ CodeableConcept ]; # 0..1 The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization or marketing status
  fhir:PackagedProductDefinition.statusDate [ dateTime ]; # 0..1 The date at which the given status became applicable
  fhir:PackagedProductDefinition.description [ markdown ]; # 0..1 Textual description. Note that this is not the name of the product
  fhir:PackagedProductDefinition.legalStatusOfSupply [ CodeableConcept ]; # 0..1 The legal status of supply of the medicinal product as classified by the regulator
  fhir:PackagedProductDefinition.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing information
  fhir:PackagedProductDefinition.characteristic [ CodeableConcept ], ... ; # 0..* Allows the key product features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"
  fhir:PackagedProductDefinition.copackagedIndicator [ boolean ]; # 0..1 States whether a drug product is supplied with another item such as a diluent or adjuvant
  fhir:PackagedProductDefinition.marketingAuthorization [ Reference(RegulatedAuthorization) ]; # 0..1 Manufacturer of this Package Item
  fhir:PackagedProductDefinition.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this Package Item
  fhir:PackagedProductDefinition.batchIdentifier [ # 0..* Batch numbering
    fhir:PackagedProductDefinition.batchIdentifier.outerPackaging [ Identifier ]; # 1..1 A number appearing on the outer packaging of a specific batch
    fhir:PackagedProductDefinition.batchIdentifier.immediatePackaging [ Identifier ]; # 0..1 A number appearing on the immediate packaging (and not the outer packaging)
  ], ...;
  fhir:PackagedProductDefinition.package [ # 0..* A packaging item, as a contained for medicine, possibly with other packaging items within
    fhir:PackagedProductDefinition.package.identifier [ Identifier ], ... ; # 0..* Including possibly Data Carrier Identifier
    fhir:PackagedProductDefinition.package.type [ CodeableConcept ]; # 0..1 The physical type of the container of the medicine
    fhir:PackagedProductDefinition.package.quantity [ integer ]; # 0..1 The quantity of this package in the medicinal product, at the current level of packaging. If specified, the outermost level is always 1
    fhir:PackagedProductDefinition.package.material [ CodeableConcept ], ... ; # 0..* Material type of the package item
    fhir:PackagedProductDefinition.package.alternateMaterial [ CodeableConcept ], ... ; # 0..* A possible alternate material for the packaging
    fhir:PackagedProductDefinition.package.shelfLifeStorage [ ProductShelfLife ], ... ; # 0..* Shelf Life and storage information
    fhir:PackagedProductDefinition.package.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this Package Item
    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 [ Reference(DeviceDefinition|ManufacturedItemDefinition) ], ... ; # 0..* The manufactured item or device as contained in the packaged medicinal product
      # PackagedProductDefinition.package.containedItem.amount[x] : 0..1 The number of this type of item within this packaging. One of these 2
        fhir:PackagedProductDefinition.package.containedItem.amountQuantity [ Quantity ]
        fhir:PackagedProductDefinition.package.containedItem.amountInteger [ integer ]
    ], ...;
    fhir:PackagedProductDefinition.package.package [ See PackagedProductDefinition.package ], ... ; # 0..* Allows containers within containers
  ], ...;
]

Changes since R3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. PackagedProductDefinition ΣTUDomainResourceA medicinal product in a container or package
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierUnique identifier
... name Σ0..1stringA name for this product pack. Typically what it would be listed as in a drug formulary
... subject Σ0..*Reference(MedicinalProductDefinition)The product that this is a pack for
... statusDate Σ0..1dateTimeThe date at which the given status became applicable
... description Σ0..1markdownTextual description. Note that this is not the name of the product
... legalStatusOfSupply Σ0..1CodeableConceptThe legal status of supply of the medicinal product as classified by the regulator
... marketingStatus Σ0..*MarketingStatusMarketing information
... characteristic Σ0..*CodeableConceptAllows the key product features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"
... copackagedIndicator Σ0..1booleanStates whether a drug product is supplied with another item such as a diluent or adjuvant
... marketingAuthorization Σ0..1Reference(RegulatedAuthorization)Manufacturer of this Package Item
... manufacturer Σ0..*Reference(Organization)Manufacturer of this Package Item
... batchIdentifier Σ0..*BackboneElementBatch numbering
.... outerPackaging Σ1..1IdentifierA number appearing on the outer packaging of a specific batch
.... immediatePackaging Σ0..1IdentifierA number appearing on the immediate packaging (and not the outer packaging)
... package Σ0..*BackboneElementA packaging item, as a contained for medicine, possibly with other packaging items within
.... identifier Σ0..*IdentifierIncluding possibly Data Carrier Identifier
.... type Σ0..1CodeableConceptThe physical type of the container of the medicine
.... quantity Σ0..1integerThe quantity of this package in the medicinal product, at the current level of packaging. If specified, the outermost level is always 1
.... material Σ0..*CodeableConceptMaterial type of the package item
.... alternateMaterial Σ0..*CodeableConceptA possible alternate material for the packaging
.... shelfLifeStorage Σ0..*ProductShelfLifeShelf Life and storage information
.... manufacturer Σ0..*Reference(Organization)Manufacturer of this Package Item
.... property Σ0..*BackboneElementGeneral characteristics of this item
..... type Σ1..1CodeableConceptA code expressing the type of characteristic
..... value[x] Σ0..1A value for the characteristic
...... valueCodeableConceptCodeableConcept
...... valueQuantityQuantity
...... valueDatedate
...... valueBooleanboolean
...... valueAttachmentAttachment
.... containedItem Σ0..*BackboneElementThe item(s) within the packaging
..... item Σ0..*Reference(ManufacturedItemDefinition | DeviceDefinition)The manufactured item or device as contained in the packaged medicinal product
..... amount[x] Σ0..1The number of this type of item within this packaging
...... amountQuantityQuantity
...... amountIntegerinteger
.... package Σ0..*see packageAllows containers within containers

doco Documentation for this format

UML Diagram (Legend)

PackagedProductDefinition (DomainResource)Unique identifieridentifier : Identifier [0..*]A name for this product pack. Typically what it would be listed as in a drug formularyname : string [0..1]The product that this is a pack forsubject : Reference [0..*] « MedicinalProductDefinition »The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization or marketing statusstatus : CodeableConcept [0..1] « Identifies the level of importance to be assigned to actioning the request. (Strength=Preferred)PublicationStatus? »The date at which the given status became applicablestatusDate : dateTime [0..1]Textual description. Note that this is not the name of the productdescription : markdown [0..1]The legal status of supply of the medicinal product as classified by the regulatorlegalStatusOfSupply : CodeableConcept [0..1]Marketing informationmarketingStatus : MarketingStatus [0..*]Allows the key product features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"characteristic : CodeableConcept [0..*]States whether a drug product is supplied with another item such as a diluent or adjuvantcopackagedIndicator : boolean [0..1]Manufacturer of this Package ItemmarketingAuthorization : Reference [0..1] « RegulatedAuthorization »Manufacturer of this Package Itemmanufacturer : Reference [0..*] « Organization »BatchIdentifierA number appearing on the outer packaging of a specific batchouterPackaging : Identifier [1..1]A number appearing on the immediate packaging (and not the outer packaging)immediatePackaging : Identifier [0..1]PackageIncluding possibly Data Carrier Identifieridentifier : Identifier [0..*]The physical type of the container of the medicinetype : CodeableConcept [0..1]The quantity of this package in the medicinal product, at the current level of packaging. If specified, the outermost level is always 1quantity : integer [0..1]Material type of the package itemmaterial : CodeableConcept [0..*]A possible alternate material for the packagingalternateMaterial : CodeableConcept [0..*]Shelf Life and storage informationshelfLifeStorage : ProductShelfLife [0..*]Manufacturer of this Package Itemmanufacturer : Reference [0..*] « Organization »PropertyA code expressing the type of characteristictype : CodeableConcept [1..1]A value for the characteristicvalue[x] : DataType [0..1] « CodeableConcept|Quantity|date|boolean| Attachment »ContainedItemThe manufactured item or device as contained in the packaged medicinal productitem : Reference [0..*] « ManufacturedItemDefinition| DeviceDefinition »The number of this type of item within this packagingamount[x] : DataType [0..1] « Quantity|integer »Batch numberingbatchIdentifier[0..*]General characteristics of this itemproperty[0..*]The item(s) within the packagingcontainedItem[0..*]Allows containers within containerspackage[0..*]A packaging item, as a contained for medicine, possibly with other packaging items withinpackage[0..*]

XML Template

<PackagedProductDefinition xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Unique identifier --></identifier>
 <name value="[string]"/><!-- 0..1 A name for this product pack. Typically what it would be listed as in a drug formulary -->
 <subject><!-- 0..* Reference(MedicinalProductDefinition) The product that this is a pack for --></subject>
 <status><!-- 0..1 CodeableConcept The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization or marketing status --></status>
 <statusDate value="[dateTime]"/><!-- 0..1 The date at which the given status became applicable -->
 <description value="[markdown]"/><!-- 0..1 Textual description. Note that this is not the name of the product -->
 <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>
 <characteristic><!-- 0..* CodeableConcept Allows the key product features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack" --></characteristic>
 <copackagedIndicator value="[boolean]"/><!-- 0..1 States whether a drug product is supplied with another item such as a diluent or adjuvant -->
 <marketingAuthorization><!-- 0..1 Reference(RegulatedAuthorization) 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>
 <package>  <!-- 0..* A packaging item, as a contained for medicine, possibly with other packaging items within -->
  <identifier><!-- 0..* Identifier Including possibly Data Carrier Identifier --></identifier>
  <type><!-- 0..1 CodeableConcept The physical type of the container of the medicine --></type>
  <quantity value="[integer]"/><!-- 0..1 The quantity of this package in the medicinal product, at the current level of packaging. If specified, the outermost level is always 1 -->
  <material><!-- 0..* CodeableConcept Material type of the package item --></material>
  <alternateMaterial><!-- 0..* CodeableConcept A possible alternate material for the packaging --></alternateMaterial>
  <shelfLifeStorage><!-- 0..* ProductShelfLife Shelf Life and storage information --></shelfLifeStorage>
  <manufacturer><!-- 0..* Reference(Organization) Manufacturer of this Package Item --></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><!-- 0..* Reference(DeviceDefinition|ManufacturedItemDefinition) The manufactured item or device as contained in the packaged medicinal product --></item>
   <amount[x]><!-- 0..1 Quantity|integer The number of this type of item within this packaging --></amount[x]>
  </containedItem>
  <package><!-- 0..* Content as for PackagedProductDefinition.package Allows containers within containers --></package>
 </package>
</PackagedProductDefinition>

JSON Template

{doco
  "resourceType" : "PackagedProductDefinition",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Unique identifier
  "name" : "<string>", // A name for this product pack. Typically what it would be listed as in a drug formulary
  "subject" : [{ Reference(MedicinalProductDefinition) }], // The product that this is a pack for
  "status" : { CodeableConcept }, // The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization or marketing status
  "statusDate" : "<dateTime>", // The date at which the given status became applicable
  "description" : "<markdown>", // Textual description. Note that this is not the name of the product
  "legalStatusOfSupply" : { CodeableConcept }, // The legal status of supply of the medicinal product as classified by the regulator
  "marketingStatus" : [{ MarketingStatus }], // Marketing information
  "characteristic" : [{ CodeableConcept }], // Allows the key product features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"
  "copackagedIndicator" : <boolean>, // States whether a drug product is supplied with another item such as a diluent or adjuvant
  "marketingAuthorization" : { Reference(RegulatedAuthorization) }, // 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)
  }],
  "package" : [{ // A packaging item, as a contained for medicine, possibly with other packaging items within
    "identifier" : [{ Identifier }], // Including possibly Data Carrier Identifier
    "type" : { CodeableConcept }, // The physical type of the container of the medicine
    "quantity" : <integer>, // The quantity of this package in the medicinal product, at the current level of packaging. If specified, the outermost level is always 1
    "material" : [{ CodeableConcept }], // Material type of the package item
    "alternateMaterial" : [{ CodeableConcept }], // A possible alternate material for the packaging
    "shelfLifeStorage" : [{ ProductShelfLife }], // Shelf Life and storage information
    "manufacturer" : [{ Reference(Organization) }], // Manufacturer of this Package Item
    "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" : [{ Reference(DeviceDefinition|ManufacturedItemDefinition) }], // The manufactured item or device as contained in the packaged medicinal product
      // amount[x]: The number of this type of item within this packaging. One of these 2:
      "amountQuantity" : { Quantity }
      "amountInteger" : <integer>
    }],
    "package" : [{ Content as for PackagedProductDefinition.package }] // Allows containers within containers
  }]
}

Turtle Template

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


[ 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..* Unique identifier
  fhir:PackagedProductDefinition.name [ string ]; # 0..1 A name for this product pack. Typically what it would be listed as in a drug formulary
  fhir:PackagedProductDefinition.subject [ Reference(MedicinalProductDefinition) ], ... ; # 0..* The product that this is a pack for
  fhir:PackagedProductDefinition.status [ CodeableConcept ]; # 0..1 The status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization or marketing status
  fhir:PackagedProductDefinition.statusDate [ dateTime ]; # 0..1 The date at which the given status became applicable
  fhir:PackagedProductDefinition.description [ markdown ]; # 0..1 Textual description. Note that this is not the name of the product
  fhir:PackagedProductDefinition.legalStatusOfSupply [ CodeableConcept ]; # 0..1 The legal status of supply of the medicinal product as classified by the regulator
  fhir:PackagedProductDefinition.marketingStatus [ MarketingStatus ], ... ; # 0..* Marketing information
  fhir:PackagedProductDefinition.characteristic [ CodeableConcept ], ... ; # 0..* Allows the key product features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"
  fhir:PackagedProductDefinition.copackagedIndicator [ boolean ]; # 0..1 States whether a drug product is supplied with another item such as a diluent or adjuvant
  fhir:PackagedProductDefinition.marketingAuthorization [ Reference(RegulatedAuthorization) ]; # 0..1 Manufacturer of this Package Item
  fhir:PackagedProductDefinition.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this Package Item
  fhir:PackagedProductDefinition.batchIdentifier [ # 0..* Batch numbering
    fhir:PackagedProductDefinition.batchIdentifier.outerPackaging [ Identifier ]; # 1..1 A number appearing on the outer packaging of a specific batch
    fhir:PackagedProductDefinition.batchIdentifier.immediatePackaging [ Identifier ]; # 0..1 A number appearing on the immediate packaging (and not the outer packaging)
  ], ...;
  fhir:PackagedProductDefinition.package [ # 0..* A packaging item, as a contained for medicine, possibly with other packaging items within
    fhir:PackagedProductDefinition.package.identifier [ Identifier ], ... ; # 0..* Including possibly Data Carrier Identifier
    fhir:PackagedProductDefinition.package.type [ CodeableConcept ]; # 0..1 The physical type of the container of the medicine
    fhir:PackagedProductDefinition.package.quantity [ integer ]; # 0..1 The quantity of this package in the medicinal product, at the current level of packaging. If specified, the outermost level is always 1
    fhir:PackagedProductDefinition.package.material [ CodeableConcept ], ... ; # 0..* Material type of the package item
    fhir:PackagedProductDefinition.package.alternateMaterial [ CodeableConcept ], ... ; # 0..* A possible alternate material for the packaging
    fhir:PackagedProductDefinition.package.shelfLifeStorage [ ProductShelfLife ], ... ; # 0..* Shelf Life and storage information
    fhir:PackagedProductDefinition.package.manufacturer [ Reference(Organization) ], ... ; # 0..* Manufacturer of this Package Item
    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 [ Reference(DeviceDefinition|ManufacturedItemDefinition) ], ... ; # 0..* The manufactured item or device as contained in the packaged medicinal product
      # PackagedProductDefinition.package.containedItem.amount[x] : 0..1 The number of this type of item within this packaging. One of these 2
        fhir:PackagedProductDefinition.package.containedItem.amountQuantity [ Quantity ]
        fhir:PackagedProductDefinition.package.containedItem.amountInteger [ integer ]
    ], ...;
    fhir:PackagedProductDefinition.package.package [ See PackagedProductDefinition.package ], ... ; # 0..* Allows containers within containers
  ], ...;
]

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 spreadsheet version & the dependency analysis a

PathDefinitionTypeReference
PackagedProductDefinition.status Identifies the level of importance to be assigned to actioning the request.PreferredPublicationStatus

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionExpressionIn Common
devicereferenceA device associated within packaged product
(DeviceDefinition)
identifiertokenUnique identifierPackagedProductDefinition.identifier
manufactured-itemreferenceA manufactured item of medication within this packaged product
(ManufacturedItemDefinition)
name NtokenA name for this product pack. Typically what it would be listed as in a drug formularyPackagedProductDefinition.name
statustokenThe status within the lifecycle of this product. A high level status, this is not intended to duplicate details carried elswhere such as legal status, or authorization or marketing statusPackagedProductDefinition.status
subjectreferenceThe product that this is a pack forPackagedProductDefinition.subject
(MedicinalProductDefinition)