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

EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: EmaWriteApiPackagedProductDefinition - Mappings

Draft as of 2025-08-08

Mappings for the emaWriteApiPackagedProductDefinition resource profile.

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

EmaWriteApiPackagedProductDefinition
PackagedProductDefinitionadministrative.medication
   identifierFiveWs.class
   identifier (emaPcIdentifier)FiveWs.class
   identifier (dataCarrierGs1)FiveWs.class
   identifier (dataCarrierPharmacy)FiveWs.class
   identifier (dataCarrierNationalTrade)FiveWs.class

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

EmaWriteApiPackagedProductDefinition
PackagedProductDefinitionPackaged Medicinal Product
   identifierPackaged Medicinal Product.PCID
   identifier (emaPcIdentifier)Packaged Medicinal Product.PCID
   identifier (dataCarrierGs1)Packaged Medicinal Product.PCID
   identifier (dataCarrierPharmacy)Packaged Medicinal Product.PCID
   identifier (dataCarrierNationalTrade)Packaged Medicinal Product.PCID
   packageFor(the link from Packaged Medicinal Product to Medicinal Product)
   statusn/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
   manufacturerPackaged Medicinal Product.Manufacturer / Establishment (Organisation)
   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)

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

EmaWriteApiPackagedProductDefinition
PackagedProductDefinitionEntity, Role, or Act
   identifier
   identifier (emaPcIdentifier)
      idn/a
      systemII.root or Role.id.root
      valueII.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
   identifier (dataCarrierGs1)
      idn/a
      extensionn/a
      useRole.code or implied by context
      typeRole.code or implied by context
      systemII.root or Role.id.root
      valueII.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
      periodRole.effectiveTime or implied by context
      assignerII.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
   identifier (dataCarrierPharmacy)
      idn/a
      extensionn/a
      useRole.code or implied by context
      typeRole.code or implied by context
      systemII.root or Role.id.root
      valueII.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
      periodRole.effectiveTime or implied by context
      assignerII.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
   identifier (dataCarrierNationalTrade)
      idn/a
      extensionn/a
      useRole.code or implied by context
      typeRole.code or implied by context
      systemII.root or Role.id.root
      valueII.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
      periodRole.effectiveTime or implied by context
      assignerII.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
   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
   manufacturer
      idn/a
      referenceN/A
      typeN/A
      identifier.identifier
      displayN/A
   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