Release 5 Draft Ballot

This page is part of the FHIR Specification (v4.6.0: R5 Draft Ballot - see ballot notes). The current version which supercedes this version is 5.0.0. 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 Work GroupMaturity Level: N/AStandards Status: InformativeSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Mappings:

IDMP Mapping

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

15.6.7.1 IDMP Mapping (https://en.wikipedia.org/wiki/Identification_of_medicinal_products )

RegulatedAuthorizationMarketing Authorisation, Clinical Trial Authorisation
    identifierMarketing Authorisation.Marketing Authorisation Number
    subject(the link to Medicinal Product or Packaged Medicinal Product)
    typen/a
    descriptionn/a
    regionMarketing Authorisation.Country
    statusMarketing Authorisation.Authorisation Status
    statusDateMarketing Authorisation.Authorisation Status Date
    validityPeriodMarketing Authorisation.Validity Period Start, Marketing Authorisation.Validity Period End
    indicationn/a
    intendedUsen/a
    basisMarketing Authorisation.Status Reasons.Legal Grounds
    relatedDateMarketing Authorisation.Data Exclusivity Start Date, Marketing Authorisation.Data Exclusivity End Date , Marketing Authorisation.Date of First Authorisation, Marketing Authorisation.International Birth Date, Status Reasons.Restore Date
        date[x](dates as above)
        type(type of date from the ones above)
    jurisdictionalAuthorizationMarketing Authorisation.Jurisdictional Marketing Authorisation
    holderMarketing Authorisation.Marketing Authorisation Holder (Organisation)
    regulatorMarketing Authorisation.Medicines Regulatory Agency (Organisation)
    attachedDocumentn/a
    caseMarketing Authorisation.Marketing Authorisation Procedure, Marketing Authorisation Procedure.Marketing Authorisation Application
        identifierMarketing Authorisation Procedure.Procedure Identifier / Number, Marketing Authorisation Application.Application Identifier / Number
        typeMarketing Authorisation Procedure.Procedure Type, Marketing Authorisation Application.Application Type
        statusn/a
        date[x]Marketing Authorisation Procedure.Procedure Date Start, Marketing Authorisation Procedure.Procedure Date End, Marketing Authorisation Application.Application Date
        applicationMarketing Authorisation.Marketing Authorisation Application