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: EmaWriteApiMedicinalProductDefinitionRestrictions - Mappings

Draft as of 2025-08-08

Mappings for the emaWriteApiMedicinalProductDefinitionRestrictions resource profile.

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

EmaWriteApiMedicinalProductDefinitionRestrictions
MedicinalProductDefinitionadministrative.medication
   identifierFiveWs.class

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

EmaWriteApiMedicinalProductDefinitionRestrictions
MedicinalProductDefinitionMedicinal Product and Investigational Medicinal Product
   identifierMedicinal Product.MPID, Investigational Medicinal Product.IMPID
   type(indicates if this is Medicinal Product or an Investigational Medicinal Product)
   domainn/a
   statusn/a
   combinedPharmaceuticalDoseFormMedicinal Product.Combined Pharmaceutical Dose Form
   indication(roll up of all text in Therapeutic Indication.Indication Text, for common case where information is not granular)
   legalStatusOfSupplyMarketing Authorisation.Legal Status of Supply (moved here for practicality)
   additionalMonitoringIndicatorMedicinal Product.Additional Monitoring Indicator
   pediatricUseIndicatorMedicinal Product.Pediatric Use Indicator
   classificationProduct Classification.Value
   comprisedOfManufactured Item
   attachedDocumentAttached Document
   masterFileMaster File
   contactn/a
      typen/a
      contactn/a
   clinicalTrialInvestigational Medicinal Product.Clinical Trial Status
   nameMedicinal Product Name
      productNameMedicinal Product Name.Full Name
      typen/a
      part(any and all of the name parts e.g. Medicinal Product Name.Formulation Part)
         part(text of any of the name parts e.g. Medicinal Product Name.Formulation Part)
         type(which of the name parts this is e.g. Formulation Part)
      usageCountry / Language
         countryCountry / Language.Country
         jurisdictionCountry / Language.Jurisdiction
         languageCountry / Language.Language
   crossReferenceProduct Cross-Reference
      productProduct Cross-Reference
      typeProduct Cross-Reference
   operationManufacturing / Business Operation
      typeManufacturing / Business Operation.Operation Type
      effectiveDateManufacturing / Business Operation.Effective Date
      organizationManufacturer / Establishment (Organisation)
      confidentialityIndicatorManufacturing / Business Operation.Confidentiality Indicator
   characteristicPackage Item (Container).Physical Characteristics
      typePhysical Characteristics, all attributes
      value[x]Physical Characteristics, attribute's value

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

EmaWriteApiMedicinalProductDefinitionRestrictions
MedicinalProductDefinitionEntity, Role, or Act,ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']
   extensionN/A
   identifierManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code
   typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asSpecializedKind.generalizedMaterialKind.code
   domainManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{domain}'].value
   statusn/a
   combinedPharmaceuticalDoseFormManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].formCode
   indicationManufacturedProduct[classCode='MANU'].consumedIn.substanceAdministration1.reason.indicationObservationCriterion[@code='{Observation_MedicalProblem}'].value.originalText.@value
   legalStatusOfSupplyManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].pertinentInformation.policy.code
   additionalMonitoringIndicatorManufacturedProduct[classCode='MANU'].subjectOf.policy.code
   pediatricUseIndicatorManufacturedProduct[classCode='MANU'].subjectOf.policy.code
   classificationManufacturedProduct[classCode='MANU'].manufacturedProduct/asSpecializedKind/generalizedMaterialKind/code
   comprisedOfManufacturedProduct[classCode='MANU'].manufacturedProduct.formCode
   attachedDocumentManufacturedProduct[classCode='MANU'].subjectOf.document
   masterFileManufacturedProduct[classCode='MANU'].subjectOf.document
   contactManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty
      idn/a
      extensionn/a
      modifierExtensionN/A
      typeManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty.code
      contactManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty
   clinicalTrialManufacturedProduct[classCode='MANU'].subjectOf.monitoringProgram
   nameManufacturedProduct[classCode='MANU'].manufacturedProduct.name
      idn/a
      extensionn/a
      modifierExtensionN/A
      productNameManufacturedProduct[classCode='MANU'].manufacturedProduct.name
      typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
      partManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
         idn/a
         extensionn/a
         modifierExtensionN/A
         partManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
         typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
      usageManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity
         idn/a
         extensionn/a
         modifierExtensionN/A
         countryManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
         jurisdictionManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
         languageManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.name.@xml:lang
   crossReferenceManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity
      idn/a
      extensionn/a
      modifierExtensionN/A
      productManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.definingMaterialKind.code
      typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.code
   operationManufacturedProduct[classCode='MANU'].subjectOf.action
      idn/a
      extensionn/a
      modifierExtensionN/A
      typeManufacturedProduct[classCode='MANU'].subjectOf.action.code
      effectiveDateManufacturedProduct[classCode='MANU'].subjectOf.action.effectiveTime
      organizationManufacturedProduct[classCode='MANU'].subjectOf.action.participation.organzation
      confidentialityIndicatorManufacturedProduct[classCode='MANU'].subjectOf.action.confidentialityCode
   characteristicManufacturedProduct[classCode='MANU'].subjectOf.characteristic
      idn/a
      extensionn/a
      modifierExtensionN/A
      typeManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}']
      value[x]ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}'].value