EMA Write PMS API Implementation Guide - Enrichments
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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

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Official URL: http://ema.europa.eu/fhir/ImplementationGuide/emavar Version: 1.0.0
Draft as of 2025-04-04 Computable Name: EmaWritePmsApiImplementationGuideEnrichments

Overview

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.

Editable Properties

Not all properties mentioned in this document can be modified. Only the following ones are editable:

The Editable Properties

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.

Available operations

  • Get Bundle: (GET) /MedicinalProductDefinition/[pmsId]/$everything​
    • Get the Bundle containing the MedicinalProductDefinition and related PackagedProductDefinition, ActivityDefinition and RegulatedAuthorization resources​
  • Merge: (POST) /MedicinalProductDefinition/$merge​
    • The body contains the Bundle with the changes (for the editable properties)
    • Only resources that are being changed need to be sent, as well as always the MedicinalProductDefinition
    • For those resources, all resource elements must be sent, whether they are being changed or not
    • Asynchronous (202) or Synchronous (200) return

Domain Resources

The Domain Resources

User Journey

Main Flow

Main Flow

$merge Detail

Merge Flow

Errors & Warnings

Errors

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​

Warnings

The following case is allowed by the API but represent possible errors, so a warning will be given:

  • A $merge request where one or more PackagedProductDefinition do not have at least one package size​

Ignored Changes

  • Attempting to modify non-editable resource nodes will result in that node change being ignored – example: changing the MedicinalProductDefinition.domain

FHIR 4.4.0 to 5.0.0 Mapping

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

Other Information

This guide is compliant with FHIR Release 5.

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Authors and Contributors

Role Name Email
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