EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Mappings for the emaWriteApiMedicinalProductDefinitionRestrictions resource profile.
| EmaWriteApiMedicinalProductDefinitionRestrictions |
| 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 |
| status | n/a |
| combinedPharmaceuticalDoseForm | Medicinal Product.Combined Pharmaceutical Dose Form |
| 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 |
| pediatricUseIndicator | Medicinal Product.Pediatric Use Indicator |
| classification | Product Classification.Value |
| comprisedOf | Manufactured Item |
| attachedDocument | Attached Document |
| masterFile | Master File |
| contact | n/a |
| type | n/a |
| contact | n/a |
| clinicalTrial | Investigational Medicinal Product.Clinical Trial Status |
| 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 |
| EmaWriteApiMedicinalProductDefinitionRestrictions |
| MedicinalProductDefinition | Entity, Role, or Act,ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'] |
| extension | N/A |
| 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 |
| status | n/a |
| combinedPharmaceuticalDoseForm | ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT'].formCode |
| 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 |
| pediatricUseIndicator | ManufacturedProduct[classCode='MANU'].subjectOf.policy.code |
| classification | ManufacturedProduct[classCode='MANU'].manufacturedProduct/asSpecializedKind/generalizedMaterialKind/code |
| comprisedOf | ManufacturedProduct[classCode='MANU'].manufacturedProduct.formCode |
| attachedDocument | ManufacturedProduct[classCode='MANU'].subjectOf.document |
| masterFile | ManufacturedProduct[classCode='MANU'].subjectOf.document |
| contact | ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty |
| id | n/a |
| extension | n/a |
| modifierExtension | N/A |
| type | ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty.code |
| contact | ManufacturedProduct[classCode='MANU'].subjectOf.assignedEntity.assignedOrganization.contactParty |
| clinicalTrial | ManufacturedProduct[classCode='MANU'].subjectOf.monitoringProgram |
| name | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name |
| id | n/a |
| extension | n/a |
| modifierExtension | N/A |
| productName | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name |
| type | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code |
| part | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix |
| id | n/a |
| extension | n/a |
| modifierExtension | N/A |
| part | ManufacturedProduct[classCode='MANU'].manufacturedProduct.name.suffix |
| type | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity.code |
| usage | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asNamedEntity |
| id | n/a |
| extension | n/a |
| modifierExtension | N/A |
| 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 |
| id | n/a |
| extension | n/a |
| modifierExtension | N/A |
| product | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.definingMaterialKind.code |
| type | ManufacturedProduct[classCode='MANU'].manufacturedProduct.asEquivalentEntity.code |
| operation | ManufacturedProduct[classCode='MANU'].subjectOf.action |
| id | n/a |
| extension | n/a |
| modifierExtension | N/A |
| 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 |
| id | n/a |
| extension | n/a |
| modifierExtension | N/A |
| type | ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}'] |
| value[x] | ManufacturedProduct[classCode='MANU'].subjectOf.characteristic[@code='{type}'].value |