R5 Final QA

This page is part of the FHIR Specification (v5.0.0-draft-final: Final QA Preview for R5 - 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

15.1.7 Resource MedicinalProductDefinition - Mappings

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

Mappings:

FiveWs Pattern Mapping

RIM Mapping

IDMP Mapping

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

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

MedicinalProductDefinition
    identifierFiveWs.class

15.1.7.2 RIM Mapping (http://hl7.org/v3 icon)

MedicinalProductDefinitionManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']
    identifierManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code
    typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asSpecializedKind.generalizedMaterialKind.code
    domainManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{domain}'].value
    versionn/a
    statusn/a
    statusDaten/a
    descriptionManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].desc
    combinedPharmaceuticalDoseFormManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].formCode
    routeManufacturedProduct[classCode='MANU'].productOf.reconstitution.consumable.administerableMaterial.consumedIn.substanceAdministration1.routeCode
    indicationManufacturedProduct[classCode='MANU'].consumedIn.substanceAdministration1.reason.indicationObservationCriterion[@code='{Observation_MedicalProblem}'].value.originalText.@value
    legalStatusOfSupplyManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].pertinentInformation.policy.code
    additionalMonitoringIndicatorManufacturedProduct[classCode='MANU'].subjectOf.policy.code
    specialMeasuresManufacturedProduct[classCode='MANU'].subjectOf.policy.code[@nullFlavor='OTH'].displayName
    pediatricUseIndicatorManufacturedProduct[classCode='MANU'].subjectOf.policy.code
    classificationManufacturedProduct[classCode='MANU'].manufacturedProduct/asSpecializedKind/generalizedMaterialKind/code
    marketingStatusManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].statusCode
    packagedMedicinalProductManufacturedProduct[classCode='MANU'].manufacturedProduct.asContent.containerPackagedProduct.asContent.containerPackagedProduct.code
    comprisedOfManufacturedProduct[classCode='MANU'].manufacturedProduct.formCode
    ingredientManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].ingredient.ingredientSubstance.code
    impurity(to do)
    attachedDocumentManufacturedProduct[classCode='MANU'].subjectOf.document
    masterFileManufacturedProduct[classCode='MANU'].subjectOf.document
    contactManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty
        typeManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty.code
        contactManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty
    clinicalTrialManufacturedProduct[classCode='MANU'].subjectOf.monitoringProgram
    codeManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code
    nameManufacturedProduct[classCode='MANU'].manufacturedProduct.name
        productNameManufacturedProduct[classCode='MANU'].manufacturedProduct.name
        typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
        partManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
            partManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
            typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
        usageManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity
            countryManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
            jurisdictionManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
            languageManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.name.@xml:lang
    crossReferenceManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity
        productManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.definingMaterialKind.code
        typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.code
    operationManufacturedProduct[classCode='MANU'].subjectOf.action
        typeManufacturedProduct[classCode='MANU'].subjectOf.action.code
        effectiveDateManufacturedProduct[classCode='MANU'].subjectOf.action.effectiveTime
        organizationManufacturedProduct[classCode='MANU'].subjectOf.action.participation.organzation
        confidentialityIndicatorManufacturedProduct[classCode='MANU'].subjectOf.action.confidentialityCode
    characteristicManufacturedProduct[classCode='MANU'].subjectOf.characteristic
        typeManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}']
        value[x]ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}'].value

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

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
    statusDaten/a
    descriptionn/a
    combinedPharmaceuticalDoseFormMedicinal Product.Combined Pharmaceutical Dose Form
    routePharmaceutical Product.Route of Administration
    indication(roll up of all text in Therapeutic Indication.Indication Text, for common case where information is not granular)
    legalStatusOfSupplyMarketing Authorization.Legal Status of Supply (moved here for practicality)
    additionalMonitoringIndicatorMedicinal Product.Additional Monitoring Indicator
    specialMeasuresMedicinal Product.Special Measures
    pediatricUseIndicatorMedicinal Product.Pediatric Use Indicator
    classificationProduct Classification.Value
    marketingStatusMarketing Status
    packagedMedicinalProductPackaged Medicinal Product
    comprisedOfManufactured Item
    ingredientMedicinal Product.Ingredient (see also FHIR Ingredient resource)
    impurityn/a
    attachedDocumentAttached Document
    masterFileMaster File
    contactn/a
        typen/a
        contactn/a
    clinicalTrialInvestigational Medicinal Product.Clinical Trial Status
    coden/a
    nameMedicinal Product Name
        productNameMedicinal Product Name.Full Name
        typen/a
        part(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)
        usageCountry / Language
            countryCountry / Language.Country
            jurisdictionCountry / Language.Jurisdiction
            languageCountry / Language.Language
    crossReferenceProduct Cross-Reference
        productProduct Cross-Reference
        typeProduct Cross-Reference
    operationManufacturing / Business Operation
        typeManufacturing / Business Operation.Operation Type
        effectiveDateManufacturing / Business Operation.Effective Date
        organizationManufacturer / Establishment (Organisation)
        confidentialityIndicatorManufacturing / Business Operation.Confidentiality Indicator
    characteristicPackage Item (Container).Physical Characteristics
        typePhysical Characteristics, all attributes
        value[x]Physical Characteristics, attribute's value