Release 4
Biomedical Research and Regulation Work GroupMaturity Level: N/AStandards Status: InformativeSecurity Category: Anonymous Compartments: Not linked to any defined compartments

Mappings:

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

MedicinalProductDefinitionMedicinal Product and Investigational Medicinal Product
    identifierMedicinal Product.MPID, Investigational Medicinal Product.IMPID
    type(indicates if this is Medicinal Product or an Investigational Medicinal Product)
    domainn/a
    versionMedicinal Product.Header.Version Number
    statusn/a
    descriptionn/a
    combinedPharmaceuticalDoseFormMedicinal Product.Combined Pharmaceutical Dose Form
    indication(roll up of all text in Therapeutic Indication.Indication Text, for common case where information is not granular)
    legalStatusOfSupplyMarketing Authorisation.Legal Status of Supply (moved here for practicality)
    additionalMonitoringIndicatorMedicinal Product.Additional Monitoring Indicator
    specialMeasuresMedicinal Product.Special Measures
    paediatricUseIndicatorMedicinal Product.Paediatric Use Indicator
    productClassificationProduct Classification.Value
    marketingStatusMarketing Status
    pharmaceuticalProductPharmaceutical Product
    packagedMedicinalProductPackaged Medicinal Product
    ingredient
    attachedDocumentAttached Document
    masterFileMaster File
    contactn/a (requirement to cover a product specific contact)
        typen/a
        contactn/a
    clinicalTrialInvestigational Medicinal Product.Clinical Trial Status
    nameMedicinal Product Name
        productNameMedicinal Product Name.Full Name
        typen/a
        namePart(any and all of the name parts e.g. Medicinal Product Name.Formulation Part)
            part(text of any of the name parts e.g. Medicinal Product Name.Formulation Part)
            type(which of the name parts this is e.g. Formulation Part)
        countryLanguageCountry / Language
            countryCountry / Language.Country
            jurisdictionCountry / Language.Jurisdiction
            languageCountry / Language.Language
    crossReferenceProduct Cross-Reference
        product[x]Product Cross-Reference
        typeProduct Cross-Reference
    manufacturingBusinessOperationManufacturing / Business Operation
        typeManufacturing / Business Operation.Operation Type
        effectiveDateManufacturing / Business Operation.Effective Date
        manufacturerManufacturer / Establishment (Organisation)
        authorizationAn authorization for this process, possibly applying to several products or a wider scope of process of which this is a part
        confidentialityIndicatorManufacturing / Business Operation.Confidentiality Indicator