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: EmaWriteApiRegulatedAuthorization - Mappings

Draft as of 2025-04-04

Mappings for the emaWriteApiRegulatedAuthorization resource profile.

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

EmaWriteApiRegulatedAuthorization
RegulatedAuthorizationadministrative.medication
   identifierFiveWs.class
   identifier (marketingAuthorizationIdentifier)FiveWs.class
   identifier (manufacturingAuthorizationNumberIdentifier)FiveWs.class

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

EmaWriteApiRegulatedAuthorization
RegulatedAuthorizationMarketing Authorization, Clinical Trial Authorization
   identifierMarketing Authorization.Marketing Authorization Number
   identifier (marketingAuthorizationIdentifier)Marketing Authorization.Marketing Authorization Number
   identifier (manufacturingAuthorizationNumberIdentifier)Marketing Authorization.Marketing Authorization Number
   subject(the link to Medicinal Product or Packaged Medicinal Product)
   typen/a
   descriptionn/a
   regionMarketing Authorization.Country
   statusMarketing Authorization.Authorization Status
   statusDateMarketing Authorization.Authorization Status Date
   validityPeriodMarketing Authorization.Validity Period Start, Marketing Authorization.Validity Period End
   indicationn/a
   intendedUsen/a
   basisMarketing Authorization.Status Reasons.Legal Grounds
   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
      date[x] (datePeriod)Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date
      applicationMarketing Authorization.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
         date[x] (dateDateTime)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)

EmaWriteApiRegulatedAuthorization
RegulatedAuthorizationEntity, Role, or Act
   textAct.text?
   containedN/A
   modifierExtensionN/A
   identifier
   identifier (marketingAuthorizationIdentifier)
      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 (manufacturingAuthorizationNumberIdentifier)
      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)
   type
      idn/a
      codingunion(., ./translation)
   holder
      idn/a
      extensionn/a
      referenceN/A
      typeN/A
      identifier.identifier
         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
      displayN/A
   regulator
      idn/a
      extensionn/a
      referenceN/A
      typeN/A
      identifier.identifier
         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
      displayN/A
   case
      idn/a
      modifierExtensionN/A
      application
         idn/a
         extensionn/a
         modifierExtensionN/A