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15.1.7 Resource MedicinalProductDefinition - Mappings

Biomedical Research and Regulation icon Work GroupMaturity Level: N/AStandards Status: InformativeSecurity Category: Anonymous Compartments: No 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 administrative.medication
    identifier FiveWs.class

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

MedicinalProductDefinition ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']
    identifier ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code
    type ManufacturedProduct[classCode='MANU'].manufacturedProduct.asSpecializedKind.generalizedMaterialKind.code
    domain ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{domain}'].value
    version n/a
    status n/a
    statusDate n/a
    description ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].desc
    combinedPharmaceuticalDoseForm ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].formCode
    route ManufacturedProduct[classCode='MANU'].productOf.reconstitution.consumable.administerableMaterial.consumedIn.substanceAdministration1.routeCode
    indication ManufacturedProduct[classCode='MANU'].consumedIn.substanceAdministration1.reason.indicationObservationCriterion[@code='{Observation_MedicalProblem}'].value.originalText.@value
    legalStatusOfSupply ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].pertinentInformation.policy.code
    additionalMonitoringIndicator ManufacturedProduct[classCode='MANU'].subjectOf.policy.code
    specialMeasures ManufacturedProduct[classCode='MANU'].subjectOf.policy.code[@nullFlavor='OTH'].displayName
    pediatricUseIndicator ManufacturedProduct[classCode='MANU'].subjectOf.policy.code
    classification ManufacturedProduct[classCode='MANU'].manufacturedProduct/asSpecializedKind/generalizedMaterialKind/code
    marketingStatus ManufacturedProduct[classCode='MANU'].subjectOf.approval[@code='{Approval_MarketingAuthorization}'].statusCode
    packagedMedicinalProduct ManufacturedProduct[classCode='MANU'].manufacturedProduct.asContent.containerPackagedProduct.asContent.containerPackagedProduct.code
    comprisedOf ManufacturedProduct[classCode='MANU'].manufacturedProduct.formCode
    ingredient ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].ingredient.ingredientSubstance.code
    impurity (to do)
    attachedDocument ManufacturedProduct[classCode='MANU'].subjectOf.document
    masterFile ManufacturedProduct[classCode='MANU'].subjectOf.document
    contact ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty
        type ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty.code
        contact ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty
    clinicalTrial ManufacturedProduct[classCode='MANU'].subjectOf.monitoringProgram
    code ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code
    name ManufacturedProduct[classCode='MANU'].manufacturedProduct.name
        productName ManufacturedProduct[classCode='MANU'].manufacturedProduct.name
        type ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
        part ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
            part ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
            type ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
        usage ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity
            country ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
            jurisdiction ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.assigningTerritory.code
            language ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.name.@xml:lang
    crossReference ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity
        product ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.definingMaterialKind.code
        type ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.code
    operation ManufacturedProduct[classCode='MANU'].subjectOf.action
        type ManufacturedProduct[classCode='MANU'].subjectOf.action.code
        effectiveDate ManufacturedProduct[classCode='MANU'].subjectOf.action.effectiveTime
        organization ManufacturedProduct[classCode='MANU'].subjectOf.action.participation.organzation
        confidentialityIndicator ManufacturedProduct[classCode='MANU'].subjectOf.action.confidentialityCode
    characteristic ManufacturedProduct[classCode='MANU'].subjectOf.characteristic
        type ManufacturedProduct[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)

MedicinalProductDefinition Medicinal Product and Investigational Medicinal Product
    identifier Medicinal Product.MPID, Investigational Medicinal Product.IMPID
    type (indicates if this is Medicinal Product or an Investigational Medicinal Product)
    domain n/a
    version Medicinal Product.Header.Version Number
    status n/a
    statusDate n/a
    description n/a
    combinedPharmaceuticalDoseForm Medicinal Product.Combined Pharmaceutical Dose Form
    route Pharmaceutical Product.Route of Administration
    indication (roll up of all text in Therapeutic Indication.Indication Text, for common case where information is not granular)
    legalStatusOfSupply Marketing Authorisation.Legal Status of Supply (moved here for practicality)
    additionalMonitoringIndicator Medicinal Product.Additional Monitoring Indicator
    specialMeasures Medicinal Product.Special Measures
    pediatricUseIndicator Medicinal Product.Pediatric Use Indicator
    classification Product Classification.Value
    marketingStatus Marketing Status
    packagedMedicinalProduct Packaged Medicinal Product
    comprisedOf Manufactured Item
    ingredient Medicinal Product.Ingredient (see also FHIR Ingredient resource)
    impurity n/a
    attachedDocument Attached Document
    masterFile Master File
    contact n/a
        type n/a
        contact n/a
    clinicalTrial Investigational Medicinal Product.Clinical Trial Status
    code n/a
    name Medicinal Product Name
        productName Medicinal Product Name.Full Name
        type n/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)
        usage Country / Language
            country Country / Language.Country
            jurisdiction Country / Language.Jurisdiction
            language Country / Language.Language
    crossReference Product Cross-Reference
        product Product Cross-Reference
        type Product Cross-Reference
    operation Manufacturing / Business Operation
        type Manufacturing / Business Operation.Operation Type
        effectiveDate Manufacturing / Business Operation.Effective Date
        organization Manufacturer / Establishment (Organisation)
        confidentialityIndicator Manufacturing / Business Operation.Confidentiality Indicator
    characteristic Package Item (Container).Physical Characteristics
        type Physical Characteristics, all attributes
        value[x] Physical Characteristics, attribute's value