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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)

RegulatedAuthorization administrative.medication
    identifier FiveWs.class

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

RegulatedAuthorization Marketing Authorization, Clinical Trial Authorization
    identifier Marketing Authorization.Marketing Authorization Number
    subject (the link to Medicinal Product or Packaged Medicinal Product)
    type n/a
    description n/a
    region Marketing Authorization.Country
    status Marketing Authorization.Authorization Status
    statusDate Marketing Authorization.Authorization Status Date
    validityPeriod Marketing Authorization.Validity Period Start, Marketing Authorization.Validity Period End
    indication n/a
    intendedUse n/a
    basis Marketing Authorization.Status Reasons.Legal Grounds
    holder Marketing Authorization.Marketing Authorization Holder (Organisation)
    regulator Marketing Authorization.Medicines Regulatory Agency (Organisation)
    attachedDocument n/a
    case Marketing Authorization.Marketing Authorization Procedure, Marketing Authorization Procedure.Marketing Authorization Application
        identifier Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number
        type Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Application Type
        status n/a
        date[x] Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date
        application Marketing Authorization.Marketing Authorization Application