Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0-ballot - STU Ballot International flag

This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0-ballot. The current version which supersedes this version is 1.0.0. For a full list of available versions, see the Directory of published versions

Resource Profile: MedicinalProductDefinitionUvEpi - Mappings

Active as of 2022-12-04

Mappings for the MedicinalProductDefinition-uv-epi resource profile.

Mappings for RIM Mapping (http://hl7.org/v3)

MedicinalProductDefinitionUvEpi
MedicinalProductDefinitionEntity. Role, or Act, ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']
   textAct.text?
   containedN/A
   extensionN/A
   modifierExtensionN/A
   identifierManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].code
      idn/a
      extensionn/a
      useRole.code or implied by context
      typeRole.code or implied by context
      systemII.root or Role.id.root
      valueII.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
      periodRole.effectiveTime or implied by context
      assignerII.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
   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_MarketingAuthorisation}'].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_MarketingAuthorisation}'].statusCode
      idn/a
      extensionn/a
      modifierExtensionN/A
   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
      idn/a
      extensionn/a
      modifierExtensionN/A
      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
      idn/a
      extensionn/a
      modifierExtensionN/A
      productNameManufacturedProduct[classCode='MANU'].manufacturedProduct.name
      typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
      partManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
         idn/a
         extensionn/a
         modifierExtensionN/A
         partManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
         typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
      part (ProprietaryNamePart)ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
         idn/a
         extensionn/a
         modifierExtensionN/A
         partManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
         typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
      part (Non-proprietaryNamePart)ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
         idn/a
         extensionn/a
         modifierExtensionN/A
         partManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
         typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
      part (StrengthPart)ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
         idn/a
         extensionn/a
         modifierExtensionN/A
         partManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
         typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
      part (PharmaceuticalDoseFormPart)ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
         idn/a
         extensionn/a
         modifierExtensionN/A
         partManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix
         typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code
      usageManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity
         idn/a
         extensionn/a
         modifierExtensionN/A
         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
      idn/a
      extensionn/a
      modifierExtensionN/A
      productManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.definingMaterialKind.code
      typeManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.code
   operationManufacturedProduct[classCode='MANU'].subjectOf.action
      idn/a
      extensionn/a
      modifierExtensionN/A
      typeManufacturedProduct[classCode='MANU'].subjectOf.action.code
         idn/a
         extensionn/a
         conceptN/A
         referenceN/A
      effectiveDateManufacturedProduct[classCode='MANU'].subjectOf.action.effectiveTime
      organizationManufacturedProduct[classCode='MANU'].subjectOf.action.participation.organzation
      confidentialityIndicatorManufacturedProduct[classCode='MANU'].subjectOf.action.confidentialityCode
   characteristicManufacturedProduct[classCode='MANU'].subjectOf.characteristic
      idn/a
      extensionn/a
      modifierExtensionN/A
      typeManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}']
      value[x]ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}'].value

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

MedicinalProductDefinitionUvEpi
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 Authorisation.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)
      part (ProprietaryNamePart)(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)
      part (Non-proprietaryNamePart)(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)
      part (StrengthPart)(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)
      part (PharmaceuticalDoseFormPart)(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

Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

MedicinalProductDefinitionUvEpi
MedicinalProductDefinitionadministrative.medication
   identifierFiveWs.class