EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build
EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Official URL: http://ema.europa.eu/fhir/ImplementationGuide/emavar | Version: 1.0.0 | |||
Draft as of 2025-04-04 | Computable Name: EmaWritePmsApiImplementationGuideEnrichments |
The 'EMA Write PMS API Implementation Guide - Enrichments' describes a subset of the PMS data.
All the data presented in this document can be read from PMS in FHIR 5.0.0 format.
This document also presents a (smaller) subset that is updatable in the current version of the API.
These profiles describe specifically the resources containing manufacturer-related ESMP (European Shortages Monitoring Platform) properties, which are the MedicinalProductDefinition, the PackagedProductDefinition, the ActivityDefinition and the RegulatedAuthorization.
Not all properties mentioned in this document can be modified. Only the following ones are editable:
Some data items in the table shown are not editable (marked as READ ONLY). These are shown to contrast them to similar data items which are editable.
The following cases are not allowed by the API and will be rejected:
A $merge request where MedicinalProductDefinition.meta.versionId differs from the one in PMS
A $merge request containing the Creation/Deletion of a MedicinalProductDefinition, PackagedProductDefinition or Marketing RegulatedAuthorization
A $merge request containing duplicated manufacturers for the same operation
A $merge request where one or more operations don't have a manufacturer
A $merge request where one or more manufacturers do not have at least a manufacturer operation
The following case is allowed by the API but represent possible errors, so a warning will be given:
Name and PMS Reference | FHIR 4.4.0 | FHIR 5.0.0 |
---|---|---|
1.2. Medicinal Product Identifier (MPID) | MedicinalProductDefinition.identifier[system='http://ema.europa.eu/fhir/mpId'].value | MedicinalProductDefinition.identifier[system='http://ema.europa.eu/fhir/mpId'].value |
1.3. Domain | MedicinalProductDefinition.domain.coding[system='https://spor.ema.europa.eu/v1/lists/100000000004'].code | MedicinalProductDefinition.domain.coding[system='https://spor.ema.europa.eu/v1/lists/100000000004'].code |
1.4. Type | MedicinalProductDefinition.type.coding[system='https://spor.ema.europa.eu/v1/lists/200000025915'].code | MedicinalProductDefinition.type.coding[system='https://spor.ema.europa.eu/v1/lists/200000025915'].code |
1.5. (Authorised) pharmaceutical form | MedicinalProductDefinition.extension[url='authorisedDoseForm'].valueCodeableConcept.coding[system=200000000006 OR 200000000004 OR 200000000007 OR 200000000008].code | MedicinalProductDefinition.indication.extension[url='authorisedDoseForm'].valueCodeableConcept.coding[system=200000000006 OR 200000000004 OR 200000000007 OR 200000000008].code |
1.6. Combined pharmaceutical dose form | MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding[url='https://spor.ema.europa.eu/v1/lists/200000000006'].code | MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding[url='https://spor.ema.europa.eu/v1/lists/200000000006'].code |
1.7. Legal status of supply | MedicinalProductDefinition.legalStatusOfSupply.coding[system='https://spor.ema.europa.eu/v1/lists/100000072051].code | MedicinalProductDefinition.legalStatusOfSupply.coding[system='https://spor.ema.europa.eu/v1/lists/100000072051].code |
1.8. Additional monitoring indicator | MedicinalProductDefinition.additionalMonitoringIndicator | MedicinalProductDefinition.additionalMonitoringIndicator |
1.9.1. Orphan Designation - Regulatory authorisation type | RegulatedAuthorization[Orphan Designation].type.coding[system='https://spor.ema.europa.eu/v1/lists/220000000060'].code (220000000062) | RegulatedAuthorization[Orphan Designation].type.coding[system='https://spor.ema.europa.eu/v1/lists/220000000060'].code (220000000062) |
1.9.2. Orphan Designation - Status | RegulatedAuthorization[Orphan Designation].status | RegulatedAuthorization[Orphan Designation].status |
1.9.3. Orphan Designation - Number | RegulatedAuthorization.identifier[system='http://ema.europa.eu/fhir/marketingAuthorizationNumber'].value Note: There are plans to make it: 'orphanDesignationNumber' in the future |
RegulatedAuthorization.identifier[system='http://ema.europa.eu/fhir/marketingAuthorizationNumber'].value Note: There are plans to make it: 'orphanDesignationNumber' in the future |
1.9.4. Orphan Designation - Status date | RegulatedAuthorization[Orphan Designation].statusDate | RegulatedAuthorization[Orphan Designation].statusDate |
1.9.5. Orphan Designation - Market Exclusivity Start Date | RegulatedAuthorization[Orphan Designation].validityPeriod.start | RegulatedAuthorization[Orphan Designation].validityPeriod.start |
1.10. Paediatric use indicator | MedicinalProductDefinition.paediatricUseIndicator | MedicinalProductDefinition.pediatricUseIndicator |
1.11. Full indication text | MedicinalProductDefinition.indication | MedicinalProductDefinition.indication |
1.11.1. Language | MedicinalProductDefinition.indication.extension[url='http://ema.europa.eu/fhir/extension/language].valueCoding Note: There are plans to make it MedicinalProductDefinition.indication.extension[url='http://hl7.org/fhir/StructureDefinition/language].valueCoding |
MedicinalProductDefinition.indication.extension[url='http://ema.europa.eu/fhir/extension/language].valueCoding Note: There are plans to make it MedicinalProductDefinition.indication.extension[url='http://hl7.org/fhir/StructureDefinition/language].valueCoding |
1.12. EURD ID | MedicinalProductDefinition.identifier[system='http://ema.europa.eu/fhir/eurdId'].value | MedicinalProductDefinition.identifier[system='http://ema.europa.eu/fhir/eurdId'].value |
1.13.1. XEVMPD product type information | MedicinalProductDefinition.productClassification.coding[system='https://spor.ema.europa.eu/v1/lists/200000000324'].code | MedicinalProductDefinition.classification.coding[system='https://spor.ema.europa.eu/v1/lists/200000000324'].code |
1.13.2. Legal basis | MedicinalProductDefinition.productClassification.coding[system='https://spor.ema.europa.eu/v1/lists/100000116045'].code | MedicinalProductDefinition.classification.coding[system='https://spor.ema.europa.eu/v1/lists/100000116045'].code |
1.13.3. ATC code | MedicinalProductDefinition.productClassification.coding[system='https://spor.ema.europa.eu/v1/lists/100000093533'].code | MedicinalProductDefinition.classification.coding[system='https://spor.ema.europa.eu/v1/lists/100000093533'].code |
1.13.3.1. ATC request | MedicinalProductDefinition.productClassification.coding[system='https://spor.ema.europa.eu/v1/lists/100000093533'].extension[url='atcPending'].valueCode | MedicinalProductDefinition.classification.extension[url='http://ema.europa.eu/fhir/extension/atcPending'].valueString (with a bool in reality) |
1.13.4. Medicinal product category | MedicinalProductDefinition.productClassification.coding[system='https://spor.ema.europa.eu/v1/lists/100000155526'].code | MedicinalProductDefinition.classification.coding[system='https://spor.ema.europa.eu/v1/lists/100000155526'].code |
1.13.5. Genetically Modified Organisms (GMOs) | MedicinalProductDefinition.characteristic (BOOLEAN) | MPD.characteristic.type.coding[url='https://spor.ema.europa.eu/v1/lists/gmo'].boolean |
1.13.6. National Classification (TO BE DELETED) | MedicinalProductDefinition.productClassification.coding[system='https://spor.ema.europa.eu/v1/lists/200000016508'].code | MedicinalProductDefinition.name.part.part |
1.14.1. Full name | MedicinalProductDefinition.name.productName | MedicinalProductDefinition.name.productName |
1.14.2.1. Country | MedicinalProductDefinition.name.countryLanguage.country.coding[system='https://spor.ema.europa.eu/v1/lists/100000000002'].code | MedicinalProductDefinition.name.usage.country.coding[system='https://spor.ema.europa.eu/v1/lists/100000000002'].code |
1.14.2.2. Language | MedicinalProductDefinition.name.countryLanguage.language.coding[system='https://spor.ema.europa.eu/v1/lists/100000072057'].code | MedicinalProductDefinition.name.usage.language.coding[system='https://spor.ema.europa.eu/v1/lists/100000072057'].code |
1.14.3.1. Name part type | MedicinalProductDefinition.name.namePart.type.coding['https://spor.ema.europa.eu/v1/lists/220000000000'].code | MedicinalProductDefinition.name.part.type.coding['https://spor.ema.europa.eu/v1/lists/220000000000'].code |
1.14.3.2. Name part text | MedicinalProductDefinition.name.namePart.part | MedicinalProductDefinition.name.part.part |
1.15. Pharmacovigilance master file | MedicinalProductDefinition.masterFile -> DocumentReference | MedicinalProductDefinition.masterFile -> DocumentReference |
1.16.1. QPPV Identifier | MedicinalProductDefinition.contact.contact(PractitionerRole).identifier[system='QPPVidentifier'].value | MedicinalProductDefinition.contact.contact(PractitionerRole).identifier[system='QPPVidentifier'].value |
1.16.2. QPPV Role | MedicinalProductDefinition.contact.type.coding[system='https://spor.ema.europa.eu/v1/lists/100000154441'].code | MedicinalProductDefinition.contact.type.coding[system='https://spor.ema.europa.eu/v1/lists/100000154441'].code |
1.17.1. Pharmacovigilance - E-mail address | MedicinalProductDefinition.contact(Organization).contact.telecom | MedicinalProductDefinition.contact(Organization).contact.telecom |
1.17.2. Pharmacovigilance - Phone number | MedicinalProductDefinition.contact(Organization).contact.telecom | MedicinalProductDefinition.contact(Organization).contact.telecom |
1.17.3. Pharmacovigilance - Role | MedicinalProductDefinition.contact(Organization).type.coding[system='https://spor.ema.europa.eu/v1/lists/100000154441'].code | MedicinalProductDefinition.contact(Organization).type.coding[system='https://spor.ema.europa.eu/v1/lists/100000154441'].code |
1.18. Attached document | MedicinalProductDefinition.attachedDocument -> DocumentReference | MedicinalProductDefinition.attachedDocument -> DocumentReference |
1.19.1. Product cross-reference type | MedicinalProductDefinition.crossReference.type.coding[system='https://spor.ema.europa.eu/v1/lists/220000000017'].code | MedicinalProductDefinition.crossReference.type.coding[system='https://spor.ema.europa.eu/v1/lists/220000000017'].code |
1.19.2. Product cross-reference resource identifier | MedicinalProductDefinition.crossReference.productReference[system='http://spor.azure-api.net/pms/api/v2'].value | MedicinalProductDefinition.crossReference.product.reference.identifier[system='http://spor.azure-api.net/pms/api/v2'].value |
1.20. Manufacturer (New) | PackagedProductDefinition.manufacturer.extension[url='manufacturingBusinessOperation'].valueReference -> ActivityDefinition | PackagedProductDefinition.manufacturer.extension[url='http://ema.europa.eu/fhir/extension/operation'].valueReference -> ActivityDefinition |
2.1. Manufacturer | ActivityDefinition.participant.extension[url='http://ema.europa.eu/fhir/extension/manufacturingBusinessOperation'].valueReference.reference (LOC ID) | ActivityDefinition.participant.typeReference.identifier[system='locations'].value (LOC ID) |
2.2. Manufacturing business operation type | ActivityDefinition.code.coding[system='https://spor.ema.europa.eu/v1/lists/100000160406'].code | ActivityDefinition.code.coding[system='https://spor.ema.europa.eu/v1/lists/100000160406'].code |
2.3. Manufacturing operation start date | ActivityDefinition.effectivePeriod.start | ActivityDefinition.effectivePeriod.start |
2.4. Manufacturing operation end date | ActivityDefinition.effectivePeriod.end | ActivityDefinition.effectivePeriod.end |
2.5. Confidentiality indicator | MedicinalProductDefinition.manufacturingBusinessOperation.confidentialityIndicator.coding[system='https://spor.ema.europa.eu/v1/lists/200000004983'].code | MedicinalProductDefinition.manufacturingBusinessOperation.confidentialityIndicator.coding[system='https://spor.ema.europa.eu/v1/lists/200000004983'].code |
2.6. Manufacturing authorisation reference number | RegulatedAuthorization.identifier[system='manufacturingAuthorizationNumber'].value (subject reference to relevant ActivityDefinition) | ActivityDefinition <- RegulatedAuthorisation[MAN].identifier[system='http://ema.europa.eu/fhir/manufacturingAuthorizationNumber'].value |
2.7. Effective date | RegulatedAuthorization.validityPeriod.start (subject reference to relevant ActivityDefinition) | ActivityDefinition <- RegulatedAuthorisation[MAN].validityPeriod.start |
2.8. Medicines Regulatory Agency Organisation | RegulatedAuthorization.regulator.value ex: http://spor.ema.europa.eu/v1/locations/LOC-100020264 | ActivityDefinition <- RegulatedAuthorization[MAN].regulator.reference -> Organization.identifier[system='locations'].value |
3.1. Regulatory authorisation type | RegulatedAuthorization.type.coding[system='https://spor.ema.europa.eu/v1/lists/220000000060'].code | MedicinalProductDefinition <- RegulatedAuthorisation[type.coding.system='https://spor.ema.europa.eu/v1/lists/220000000060' | type.coding.code='220000000061'] |
3.2. Marketing authorisation number | RegulatedAuthorization.identifier.coding[system='https://spor.ema.europa.eu/v1/lists/220000000060'].code | MedicinalProductDefinition <- RegulatedAuthorization.identifier[system='http://ema.europa.eu/fhir/marketingAuthorizationNumber'].value |
3.3. Country | RegulatedAuthorization.region.coding[system='https://spor.ema.europa.eu/v1/lists/100000000002'].code | MedicinalProductDefinition <- RegulatedAuthorisation.case.extension[url='http://ema.europa.eu/fhir/extension/referenceCountry'].valueCoding[system='https://spor.ema.europa.eu/v1/lists/100000000002'].value |
3.4. Authorisation status | RegulatedAuthorization.status.coding[system='https://spor.ema.europa.eu/v1/lists/100000072049'].code | MedicinalProductDefinition <- RegulatedAuthorization.status |
3.5. Authorisation status date | RegulatedAuthorization.statusDate | MedicinalProductDefinition <- RegulatedAuthorization.statusDate |
3.6. Date of first authorisation | RegulatedAuthorization.relatedDate.dateDateTime or RegulatedAuthorization.relatedDate.dateDateTime.extension.dataAbsentReason | MedicinalProductDefinition <- RegulatedAuthorization.extension[url='http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation'] |
3.7. International birth date | RegulatedAuthorization.relatedDate.dateDateTime or RegulatedAuthorization.relatedDate.dateDateTime.extension.dataAbsentReason | MedicinalProductDefinition <- RegulatedAuthorization.extension[url='http://ema.europa.eu/fhir/extension/internationalBirthDate'] |
3.8. Marketing authorisation holder (organisation) | RegulatedAuthorization.holder.value | MedicinalProductDefinition <- RegulatedAuthorization.holder.value |
3.9. (Marketing authorisation) regulator | RegulatedAuthorization.regulator.value | MedicinalProductDefinition <- RegulatedAuthorization.regulator.value |
3.10.1. Procedure Identifier | RegulatedAuthorization.case.identifier[system='http://ema.europa.eu/fhir/procedureIdentifierNumber'].value | MedicinalProductDefinition <- RegulatedAuthorization.case.identifier[system='http://ema.europa.eu/fhir/procedureIdentifierNumber'].value |
3.10.2. Procedure type – Medicines approval system | RegulatedAuthorization.case.type.coding[system='https://spor.ema.europa.eu/v1/lists/100000154442'].code | RegulatedAuthorisation[type.coding.system='https://spor.ema.europa.eu/v1/lists/220000000060' | type.coding.code='220000000061'].case.type.coding[system='https://spor.ema.europa.eu/v1/lists/100000154442'].code |
3.10.3. Procedure start date | RegulatedAuthorization.case.datePeriod.start | RegulatedAuthorization.case.datePeriod.start |
3.10.4. Procedure end date | RegulatedAuthorization.case.datePeriod.end | RegulatedAuthorization.case.datePeriod.end |
3.10.5.1. Regulatory application Identifier/Number | RegulatedAuthorization.case.application.identifier[system='http://ema.europa.eu/fhir/applicationIdentifierNumber'].value | RegulatedAuthorization.case.identifier |
3.10.5.2. Regulatory application type | RegulatedAuthorization.case.application.type.coding[system='https://spor.ema.europa.eu/v1/lists/100000155688'].code | RegulatedAuthorization.case.application.type.coding[system='https://spor.ema.europa.eu/v1/lists/100000155688'].code |
3.10.5.3. Regulatory Application end date | RegulatedAuthorization.case.application.dateDateTime | RegulatedAuthorization.case.application.dateDateTime |
5.1. Packaged Medicinal Product Identifier | PackagedProductDefinition.identifier[system='http://ema.europa.eu/fhir/pcId'].value | PackagedProductDefinition.identifier[system='http://ema.europa.eu/fhir/pcId'].value |
5.2. Package description | PackagedProductDefinition.description | PackagedProductDefinition.description |
5.2.1. Language | PackagedProductDefinition.description.extension[url='language'].valueCodeableConcept.coding[system='https://spor.ema.europa.eu/v1/lists/100000072057'].code | PackagedProductDefinition.description.extension[url='language'].valueCodeableConcept.coding[system='https://spor.ema.europa.eu/v1/lists/100000072057'].code |
5.3. Manufacturer | PackagedProductDefinition.manufacturer.extension[url='manufacturingBusinessOperation'].valueReference -> ActivityDefinition | PackagedProductDefinition.manufacturer.extension[url='http://ema.europa.eu/fhir/extension/operation'].valueReference -> ActivityDefinition |
5.4. Pack size | PackagedProductDefinition.extension[url='containedItemQuantity'].valueQuantity[system='https://spor.ema.europa.eu/v1/lists/200000000014'].value | PackagedProductDefinition.containedItemQuantity.value |
5.4.1. Quantity operator | PackagedProductDefinition.extension.containedItemQuantity.extension[url='quantityOperator'].valueCodeableConcept.coding[system='https://spor.ema.europa.eu/v1/lists/100000000008'].code PackagedProductDefinition.extension.containedItemQuantity.comparator |
PackagedProductDefinition.containedItemQuantity.unit + .comparator + .system + .code |
5.5. Legal status of supply | PackagedProductDefinition.legalStatusOfSupply.coding[system='https://spor.ema.europa.eu/v1/lists/100000072051'].code | PackagedProductDefinition.legalStatusOfSupply.coding[system='https://spor.ema.europa.eu/v1/lists/100000072051'].code |
5.6.1. Marketing status - country | PackagedProductDefinition.marketingStatus.country.coding[system='https://spor.ema.europa.eu/v1/lists/100000000002'].code | PackagedProductDefinition.marketingStatus.country.coding[system='https://spor.ema.europa.eu/v1/lists/100000000002'].code |
5.6.2. Marketing status - status | PackagedProductDefinition.marketingStatus.status | PackagedProductDefinition.marketingStatus.status |
5.6.3. (Marketing status) start date | PackagedProductDefinition.marketingStatus.dateRange.start | PackagedProductDefinition.marketingStatus.dateRange.start |
5.6.4. (Marketing status) end date | PackagedProductDefinition.marketingStatus.dateRange.end | PackagedProductDefinition.marketingStatus.dateRange.end |
5.6.5. Risk of supply shortage | PackagedProductDefinition.marketingStatus.extension[url='riskOfSupplyShortage'].valueBoolean | PackagedProductDefinition.marketingStatus.extension[url='riskOfSupplyShortage'].valueBoolean |
5.6.6. Risk of supply shortage comment | PackagedProductDefinition.marketingStatus.extension[url='riskOfSupplyShortageComment'].valueMarkup | PackagedProductDefinition.marketingStatus.extension[url='riskOfSupplyShortageComment'].valueMarkup |
5.6.7.1. Status reason - reason | PackagedProductDefinition.marketingStatus.extension[url='reason'].valueCodeableConcept.coding[system='https://spor.ema.europa.eu/v1/lists/200000018799'].code | PackagedProductDefinition.marketingStatus.extension[url='reason'].valueCodeableConcept.coding[system='https://spor.ema.europa.eu/v1/lists/200000018799'].code |
5.6.7.2. Status reason - restore date | PackagedProductDefinition.marketingStatus.restoreDate | PackagedProductDefinition.marketingStatus.restoreDate |
5.7.1. Marketing authorisation (Package level) - Reg Auth Type | RegulatedAuthorization.type.coding[system='https://spor.ema.europa.eu/v1/lists/220000000060'].code | PackagedProductDefinition <- RegulatedAuthorisation[type.coding.system='https://spor.ema.europa.eu/v1/lists/220000000060' | type.coding.code='220000000061'] |
5.7.2. Marketing authorisation (Package level) - Mark Auth Nr | RegulatedAuthorization.identifier[system='http://ema.europa.eu/fhir/marketingAuthorizationNumber'].value | PackagedProductDefinition <- RegulatedAuthorization.identifier[system='http://ema.europa.eu/fhir/marketingAuthorizationNumber'].value |
5.7.3. Marketing authorisation (Package level) - Country | RegulatedAuthorization.region.coding[system='https://spor.ema.europa.eu/v1/lists/100000000002'].code | PackagedProductDefinition <- RegulatedAuthorisation.case.extension[url='http://ema.europa.eu/fhir/extension/referenceCountry'].valueCoding[system='https://spor.ema.europa.eu/v1/lists/100000000002'].value |
5.7.4. Marketing authorisation (Package level) - Auth Status | RegulatedAuthorization.status | PackagedProductDefinition <- RegulatedAuthorization.status |
5.7.5. Marketing authorisation (Package level) - Status Date | RegulatedAuthorization.statusDate | PackagedProductDefinition <- RegulatedAuthorization.statusDate |
5.8.1. Package item (container) type | PackagedProductDefinition.package.type.coding[system='https://spor.ema.europa.eu/v1/lists/100000073346'].value | PackagedProductDefinition.packaging.type.coding[system='https://spor.ema.europa.eu/v1/lists/100000073346'].value |
5.8.2. Package item reference(s) | PackagedProductDefinition.package.package | PackagedProductDefinition.packaging.packaging |
5.8.3. Manufactured item reference(s) | PackagedProductDefinition.package.containeditem | PackagedProductDefinition.packaging.containeditem |
5.8.4. Device reference(s) | PackagedProductDefinition.package.containedItem | PackagedProductDefinition.packaging.containedItem |
5.8.5. Package item (container) quantity | PackagedProductDefinition.package.quantity[system='https://spor.ema.europa.eu/v1/lists/200000000014'].value | PackagedProductDefinition.packaging.quantity (INT) |
5.8.5.1. Package item (container) quantity - Operator | PackagedProductDefinition.package.quantity.extension[url='quantityOperator'].valueCodeableConcept.coding[system='https://spor.ema.europa.eu/v1/lists/100000000008'].code | - |
5.8.6. Data carrier identifier | PackagedProductDefinition.package.identifier[system='https://spor.ema.europa.eu/v1/lists/100000000009'].value | PackagedProductDefinition.packaging.identifier[system='dataCarrierIdentifier'].value |
5.8.7. Material | PackagedProductDefinition.package.material.coding[system='https://spor.ema.europa.eu/v1/lists/200000003199'].code | PackagedProductDefinition.packaging.material.coding[system='https://spor.ema.europa.eu/v1/lists/200000003199'].code |
5.8.8. Manufacturer (New) | PackagedProductDefinition.package.manufacturer.extension[url='manufacturingBusinessOperation'].valueReference | PackagedProductDefinition.packaging.manufacturer.extension[url='operation'].valueReference -> ActivityDefinition |
5.9.1. Component type | PackagedProductDefinition.package.package.type.coding[system='https://spor.ema.europa.eu/v1/lists/100000073346'].code | PackagedProductDefinition.packaging.packaging.type.coding[system='https://spor.ema.europa.eu/v1/lists/100000073346'].code |
5.9.2. Component material | PackagedProductDefinition.package.package.material.coding[system='https://spor.ema.europa.eu/v1/lists/200000003199'].code | PackagedProductDefinition.packaging.packaging.material.coding[system='https://spor.ema.europa.eu/v1/lists/200000003199'].code |
5.9.3. Manufacturer (New) | PackagedProductDefinition.package.package.manufacturer.extension[url='manufacturingBusinessOperation'].valueReference | PackagedProductDefinition.packaging.packaging.manufacturer.extension[url='operation'].valueReference -> ActivityDefinition |
5.10.5. Medical device quantity | PackagedProductDefinition.package.containedItem.amountQuantity[system='https://spor.ema.europa.eu/v1/lists/100000110633'].value PackagedProductDefinition.package.containedItem.item.reference -> DeviceDefinition |
PackagedProductDefinition.packaging.containedItem.amountQuantity[system='https://spor.ema.europa.eu/v1/lists/100000110633'].value PackagedProductDefinition.packaging.containedItem.item.reference -> DeviceDefinition |
5.10.5.1. Medical device quantity operator | PackagedProductDefinition.package.containedItem.amountQuantity.extension[url='quantityOperator'].coding[system='https://spor.ema.europa.eu/v1/lists/100000000008'].code PackagedProductDefinition.package.containedItem.amountQuantity.comparator |
PackagedProductDefinition.packaging.containedItem.amountQuantity.extension[url='comparator'].coding[system='https://spor.ema.europa.eu/v1/lists/100000000008'].code PackagedProductDefinition.packaging.containedItem.amountQuantity.comparator |
5.11.2. Manufactured item - Quantity | PackagedProductDefinition.package.containedItem.amountQuantity[system='https://spor.ema.europa.eu/v1/lists/100000110633'].value PackagedProductDefinition.package.containedItem.item.reference -> ManufacturedItemDefinition |
PackagedProductDefinition.packaging.containedItem.amountQuantity[system='https://spor.ema.europa.eu/v1/lists/100000110633'].value PackagedProductDefinition.packaging.containedItem.item.reference -> ManufacturedItemDefinition |
5.11.2.1. Manufactured item - Quantity - operator | PackagedProductDefinition.package.containedItem.amountQuantity.extension[url='quantityOperator'].coding[system='https://spor.ema.europa.eu/v1/lists/100000000008'].code PackagedProductDefinition.package.containedItem.amountQuantity.comparator |
PackagedProductDefinition.packaging.containedItem.amountQuantity.extension[url='comparator'].coding[system='https://spor.ema.europa.eu/v1/lists/100000000008'].code PackagedProductDefinition.packaging.containedItem.amountQuantity.comparator |
5.12.1. Shelf life type | PackagedProductDefinition.package.shelfLifeStorage.type.coding[system='https://spor.ema.europa.eu/v1/lists/100000073343'].code | PackagedProductDefinition.packaging.shelfLifeStorage.type.coding[system='https://spor.ema.europa.eu/v1/lists/100000073343'].code |
5.12.2. Shelf life time period and units | PackagedProductDefinition.package.shelfLifeStorage.period[system='https://spor.ema.europa.eu/v1/lists/100000110633'].value | PackagedProductDefinition.packaging.shelfLifeStorage.period[system='https://spor.ema.europa.eu/v1/lists/100000110633'].value Unit: PackagedProductDefinition.ShelfLifeStorage.period.periodDuration.unit - the UCUM unit (ex: 'h' for hour) PackagedProductDefinition.ShelfLifeStorage.period.periodDuration.code - the UCUM code (ex: 'a' for year) PackagedProductDefinition.ShelfLifeStorage.period.periodDuration.system - http://unitsofmeasure.org PackagedProductDefinition.ShelfLifeStorage.period.periodDuration.extension[url='http://ema.europa.eu/fhir/extension/codedUnit'].valueCoding.system='https://spor.ema.europa.eu/v1/lists/100000073343' PackagedProductDefinition.ShelfLifeStorage.period.periodDuration.extension[url='http://ema.europa.eu/fhir/extension/codedUnit'].valueCoding.code PackagedProductDefinition.ShelfLifeStorage.period.periodDuration.extension[url='http://ema.europa.eu/fhir/extension/codedUnit'].valueCoding.display |
5.12.3. Special precautions for storage | PackagedProductDefinition.package.shelfLifeStorage.specialPrecautionsForStorage.coding[system='https://spor.ema.europa.eu/v1/lists/100000073344'].code | PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage.coding[system='https://spor.ema.europa.eu/v1/lists/100000073344'].code |
This guide is compliant with FHIR Release 5.
Disclaimer: All proprietary documents, guides, guidance, standards, codes, and values contained herein remain the property of their respective Standards Developing Organization (SDO). The EMA does not make any claim to ownership herein.
Role | Name | |
---|---|---|
Primary Editor | Luis Gouveia | luis.gouveia@ema.ext.europa.eu |
Primary Editor | Rik Smithies | rik@nprogram.co.uk |
Contributor | Marco Oliveira | marco.oliveira@ema.ext.europa.eu |