Release 5

This page is part of the FHIR Specification (v5.0.0: R5 - STU). This is the current published version. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

15.6.7 Resource RegulatedAuthorization - Mappings

Biomedical Research and Regulation icon Work GroupMaturity Level: N/AStandards Status: InformativeSecurity Category: Anonymous Compartments: No defined compartments

Mappings:

FiveWs Pattern Mapping

IDMP Mapping

Mappings for the regulatedauthorization resource (see Mappings to Other Standards for further information & status).

15.6.7.1 FiveWs Pattern Mapping (http://hl7.org/fhir/fivews icon)

RegulatedAuthorizationadministrative.medication
    identifierFiveWs.class

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

RegulatedAuthorizationMarketing Authorization, Clinical Trial Authorization
    identifierMarketing 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
        applicationMarketing Authorization.Marketing Authorization Application