EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build

EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: EmaWriteApiPackagedProductDefinition - Mappings

Draft as of 2025-04-04

Mappings for the emaWriteApiPackagedProductDefinition resource profile.

Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

EmaWriteApiPackagedProductDefinition
PackagedProductDefinitionadministrative.medication
   identifierFiveWs.class

Mappings for IDMP Mapping (https://www.iso.org/obp/ui/#iso:std:iso:11615)

EmaWriteApiPackagedProductDefinition
PackagedProductDefinitionPackaged Medicinal Product
   identifierPackaged Medicinal Product.PCID
   namen/a
   typen/a
   packageFor(the link from Packaged Medicinal Product to Medicinal Product)
   statusn/a
   statusDaten/a
   containedItemQuantityn/a
   descriptionPackaged Medicinal Product.description
   legalStatusOfSupplyMarketing Authorization.Legal Status of Supply (for a package)
      codeMarketing Authorization.Legal Status of Supply (for a package)
      jurisdictionn/a
   marketingStatusPackaged Medicinal Product.Marketing Status
   copackagedIndicatorn/a
   manufacturerPackaged Medicinal Product.Manufacturer / Establishment (Organisation)
   attachedDocumentn/a
   packagingPackaged Medicinal Product.Package Item (Container), Package Item (Container).Package (Component)
      identifierPackage Item (Container).Data Carrier Identifier
      typePackage Item (Container).Package Item (Container) Type
      componentPartWhether this packaging item corresponds to an Package Item (Container), if false, or a Package (Component), when true
      quantityPackage Item (Container).Package Item (Container) Quantity
      materialPackage Item (Container).Material
      alternateMaterialPackage Item (Container).Alternate Material
      shelfLifeStoragePackage Item (Container).Shelf Life / Storage
      manufacturerPackage Item (Container).Manufacturer / Establishment (Organisation)
      propertyPackage Item (Container).Physical Characteristics
         typePhysical Characteristics, all attributes
         value[x]Physical Characteristics, attribute's value
      containedItemPackage Item (Container).Manufactured Item, Package Item (Container).Device
         item(the link to) Package Item (Container).Manufactured Item, Package Item (Container).Device
         amountManufactured Item.Manufactured Item Quantity
      packaging(link from Package Item (Container) to itself)
   characteristicn/a

Mappings for RIM Mapping (http://hl7.org/v3)

EmaWriteApiPackagedProductDefinition
PackagedProductDefinitionEntity, Role, or Act
   textAct.text?
   containedN/A
   extensionN/A
   modifierExtensionN/A
   containedItemQuantity
      idn/a
      extensionn/a
      valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
      comparatorIVL properties
      unitPQ.unit
      systemCO.codeSystem, PQ.translation.codeSystem
      codePQ.code, MO.currency, PQ.translation.code
   legalStatusOfSupply
      idn/a
      extensionn/a
      modifierExtensionN/A
   marketingStatus
      idn/a
      extensionn/a
      modifierExtensionN/A
      dateRange
         idn/a
         extensionn/a
         start./low
         end./high
   packaging
      idn/a
      extensionn/a
      modifierExtensionN/A
      shelfLifeStorage
         idn/a
         extensionn/a
         modifierExtensionN/A
      manufacturer
         idn/a
         extension
            idn/a
            urlN/A
            value[x]N/A
            value[x] (valueReference)N/A
         referenceN/A
         typeN/A
         identifier.identifier
         displayN/A
      property
         idn/a
         extensionn/a
         modifierExtensionN/A
      containedItem
         idn/a
         extensionn/a
         modifierExtensionN/A