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: EmaWriteApiRegulatedAuthorizationRestrictions - Mappings

Draft as of 2025-08-08

Mappings for the emaWriteApiRegulatedAuthorizationRestrictions resource profile.

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

EmaWriteApiRegulatedAuthorizationRestrictions
RegulatedAuthorizationadministrative.medication
   identifierFiveWs.class

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

EmaWriteApiRegulatedAuthorizationRestrictions
RegulatedAuthorizationMarketing Authorization, Clinical Trial Authorization
   identifierMarketing Authorization.Marketing Authorization Number
   subject(the link to Medicinal Product or Packaged Medicinal Product)
   typen/a
   regionMarketing Authorization.Country
   statusMarketing Authorization.Authorization Status
   statusDateMarketing Authorization.Authorization Status Date
   validityPeriodMarketing Authorization.Validity Period Start, Marketing Authorization.Validity Period End
   holderMarketing Authorization.Marketing Authorization Holder (Organisation)
   regulatorMarketing Authorization.Medicines Regulatory Agency (Organisation)
   attachedDocumentn/a
   caseMarketing Authorization.Marketing Authorization Procedure, Marketing Authorization Procedure.Marketing Authorization Application
      identifierMarketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number
      typeMarketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Application Type
      statusn/a
      date[x]Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date
      applicationMarketing Authorization.Marketing Authorization Application

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

EmaWriteApiRegulatedAuthorizationRestrictions
RegulatedAuthorizationEntity, Role, or Act
   extensionN/A
   case
      idn/a
      extensionn/a
      modifierExtensionN/A