Release 4B Ballot #1

This page is part of the FHIR Specification v4.1.0: R4B Ballot. About the R4B version of FHIR. 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)
    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