EMA Write PMS API Implementation Guide - Enrichments
1.2.0 - ci-build

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

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Official URL: http://ema.europa.eu/fhir/ImplementationGuide/emavar Version: 1.2.0
Draft as of 2025-10-21 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 Changed?
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 unchanged
1.3. Domain MedicinalProductDefinition.domain.coding[system='http://spor.ema.europa.eu/v1/lists/100000000004'].code MedicinalProductDefinition.domain.coding[system='http://spor.ema.europa.eu/v1/lists/100000000004'].code unchanged
1.4. Type MedicinalProductDefinition.type.coding[system='http://spor.ema.europa.eu/v1/lists/200000025915'].code MedicinalProductDefinition.type.coding[system='http://spor.ema.europa.eu/v1/lists/200000025915'].code unchanged
1.5. (Authorised) pharmaceutical form MedicinalProductDefinition.extension[url='http://ema.europa.eu/fhir/extension/authorisedDoseForm'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/200000000006' OR 200000000004 OR 200000000007 OR 200000000008].code MedicinalProductDefinition.extension[url='http://ema.europa.eu/fhir/extension/authorisedDoseForm'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/200000000006' OR 200000000004 OR 200000000007 OR 200000000008].code unchanged
1.6. Combined pharmaceutical dose form MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding[system='http://spor.ema.europa.eu/v1/lists/200000000006'].code MedicinalProductDefinition.combinedPharmaceuticalDoseForm.coding[system='http://spor.ema.europa.eu/v1/lists/200000000006'].code unchanged
1.7. Legal status of supply MedicinalProductDefinition.legalStatusOfSupply.coding[system='http://spor.ema.europa.eu/v1/lists/100000072051'].code MedicinalProductDefinition.legalStatusOfSupply.coding[system='http://spor.ema.europa.eu/v1/lists/100000072051'].code unchanged
1.8. Additional monitoring indicator MedicinalProductDefinition.additionalMonitoringIndicator.coding.code MedicinalProductDefinition.additionalMonitoringIndicator.coding.code unchanged
1.9.1. Orphan Designation - Regulatory authorisation type RegulatedAuthorization[type.coding.code='220000000062'].type.coding[system='http://spor.ema.europa.eu/v1/lists/220000000060'].code (220000000062) RegulatedAuthorization[type.coding.code='220000000062'].type.coding[system='http://spor.ema.europa.eu/v1/lists/220000000060'].code (220000000062) unchanged
1.9.2. Orphan Designation Status RegulatedAuthorization[type.coding.code='220000000062'].status.coding[system='http://spor.ema.europa.eu/v1/lists/100000072049'].code RegulatedAuthorization[type.coding.code='220000000062'].status.coding[system='http://spor.ema.europa.eu/v1/lists/100000072049'].code unchanged
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 unchanged
1.9.4. Orphan Designation Status date RegulatedAuthorization[type.coding.code='220000000062'].statusDate RegulatedAuthorization[type.coding.code='220000000062'].statusDate unchanged
1.9.5. Orphan Designation - Market Exclusivity Start Date RegulatedAuthorization[type.coding.code='220000000062'].validityPeriod.start RegulatedAuthorization[type.coding.code='220000000062'].validityPeriod.start unchanged
1.10. Paediatric use indicator MedicinalProductDefinition.paediatricUseIndicator.coding.code MedicinalProductDefinition.pediatricUseIndicator.coding.code paediatricUseIndicator spelling changed
1.11. Full indication text MedicinalProductDefinition.indication MedicinalProductDefinition.indication unchanged
1.11.1. Language MedicinalProductDefinition.indication.extension[url='http://ema.europa.eu/fhir/extension/language'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/100000072057'].code MedicinalProductDefinition.indication.extension[url='http://ema.europa.eu/fhir/extension/language'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/100000072057'].code unchanged
1.12. EURD ID MedicinalProductDefinition.identifier[system='http://ema.europa.eu/fhir/eurdId'].value MedicinalProductDefinition.identifier[system='http://ema.europa.eu/fhir/eurdId'].value unchanged
1.13.1. XEVMPD product type information MedicinalProductDefinition.productClassification.coding[system='http://spor.ema.europa.eu/v1/lists/200000000324'].code MedicinalProductDefinition.classification.coding[system='http://spor.ema.europa.eu/v1/lists/200000000324'].code productClassification renamed
1.13.2. Legal basis MedicinalProductDefinition.productClassification.coding[system='http://spor.ema.europa.eu/v1/lists/100000116045'].code MedicinalProductDefinition.classification.coding[system='http://spor.ema.europa.eu/v1/lists/100000116045'].code productClassification renamed
1.13.3. ATC code MedicinalProductDefinition.productClassification.coding[system='http://spor.ema.europa.eu/v1/lists/100000093533'].code MedicinalProductDefinition.classification.coding[system='http://spor.ema.europa.eu/v1/lists/100000093533'].code productClassification renamed
1.13.3.1. ATC request MedicinalProductDefinition.productClassification.coding[system='http://spor.ema.europa.eu/v1/lists/100000093533'].extension[url='http://ema.europa.eu/fhir/extension/atcPending'].valueCode MedicinalProductDefinition.classification.coding[system='http://spor.ema.europa.eu/v1/lists/100000093533'].extension[url='http://ema.europa.eu/fhir/extension/atcPending'].valueString (with a bool in reality) productClassification renamed
1.13.4. Medicinal product category MedicinalProductDefinition.productClassification.coding[system='http://spor.ema.europa.eu/v1/lists/100000155526'].code MedicinalProductDefinition.classification.coding[system='http://spor.ema.europa.eu/v1/lists/100000155526'].code productClassification renamed
1.14.1. Full name MedicinalProductDefinition.name.productName MedicinalProductDefinition.name.productName unchanged
1.14.2.1. Country MedicinalProductDefinition.name.countryLanguage.country.coding[system='http://spor.ema.europa.eu/v1/lists/100000000002'].code MedicinalProductDefinition.name.usage.country.coding[system='http://spor.ema.europa.eu/v1/lists/100000000002'].code countryLanguage renamed
1.14.2.2. Language MedicinalProductDefinition.name.countryLanguage.language.coding[system='http://spor.ema.europa.eu/v1/lists/100000072057'].code MedicinalProductDefinition.name.usage.language.coding[system='http://spor.ema.europa.eu/v1/lists/100000072057'].code countryLanguage renamed
1.14.3.1. Name part type MedicinalProductDefinition.name.namePart.type.coding[system='http://spor.ema.europa.eu/v1/lists/220000000000'].code MedicinalProductDefinition.name.part.type.coding[system='http://spor.ema.europa.eu/v1/lists/220000000000'].code countryLanguage renamed
1.14.3.2. Name part text MedicinalProductDefinition.name.namePart.part MedicinalProductDefinition.name.part.part countryLanguage renamed
1.15.1. Pharmacovigilance master file - type MedicinalProductDefinition.masterFile -> DocumentReference.type.coding[system='http://spor.ema.europa.eu/v1/lists/220000000070'].code MedicinalProductDefinition.masterFile -> DocumentReference.type.coding[system='http://spor.ema.europa.eu/v1/lists/220000000070'].code unchanged
1.15.2. Pharmacovigilance master file - code MedicinalProductDefinition.masterFile -> DocumentReference.identifier.value MedicinalProductDefinition.masterFile -> DocumentReference.identifier.value unchanged
1.16.1. QPPV Identifier MedicinalProductDefinition.contact[type.coding.code='100000155057'].contact -> PractitionerRole.identifier[system='http://ema.europa.eu/fhir/QPPVIdentifier'].value MedicinalProductDefinition.contact[type.coding.code='100000155057'].contact -> PractitionerRole.identifier[system='http://ema.europa.eu/fhir/QPPVIdentifier'].value unchanged
1.16.2. QPPV Role MedicinalProductDefinition.contact[type.coding.code='100000155057'].type.coding[system='http://spor.ema.europa.eu/v1/lists/100000154441'].code MedicinalProductDefinition.contact[type.coding.code='100000155057'].type.coding[system='http://spor.ema.europa.eu/v1/lists/100000154441'].code unchanged
1.17.1. Pharmacovigilance - E-mail address MedicinalProductDefinition.contact[type.coding.code='200000017719'].contact -> Organization.telecom[system='email'].value MedicinalProductDefinition.contact[type.coding.code='200000017719'].contact -> Organization.contact.telecom[system='email'].value Details moved into contact element
1.17.2. Pharmacovigilance - Phone number MedicinalProductDefinition.contact[type.coding.code='200000017719'].contact -> Organization.telecom[system='phone'].value MedicinalProductDefinition.contact[type.coding.code='200000017719'].contact -> Organization.contact.telecom[system='phone'].value Details moved into contact element
1.17.3. Pharmacovigilance - Role MedicinalProductDefinition.contact[type.coding.code='200000017719'].type.coding[system='http://spor.ema.europa.eu/v1/lists/100000154441'].code MedicinalProductDefinition.contact[type.coding.code='200000017719'].type.coding[system='http://spor.ema.europa.eu/v1/lists/100000154441'].code unchanged
1.18.1.1. Attached document identifier MedicinalProductDefinition.attachedDocument -> DocumentReference.identifier[system='http://spor.ema.europa.eu/v1/lists/220000000060/terms/100000075665'].value MedicinalProductDefinition.attachedDocument -> DocumentReference.identifier[system='http://spor.ema.europa.eu/v1/lists/220000000060/terms/100000075665'].value unchanged
1.18.3. (Attached document) type MedicinalProductDefinition.attachedDocument -> DocumentReference.type.coding.code MedicinalProductDefinition.attachedDocument -> DocumentReference.type.coding.code unchanged
1.18.5. (Attached document) language MedicinalProductDefinition.attachedDocument -> DocumentReference.content.extension[url='http://ema.europa.eu/fhir/extension/language'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/100000072057'].code MedicinalProductDefinition.attachedDocument -> DocumentReference.content.extension[url='http://ema.europa.eu/fhir/extension/language'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/100000072057'].code unchanged
1.18.6. URL value MedicinalProductDefinition.attachedDocument -> DocumentReference.content.attachment.url MedicinalProductDefinition.attachedDocument -> DocumentReference.content.attachment.url unchanged
1.20. Manufacturer reference (New) MedicinalProductDefinition.manufacturingBusinessOperation.type.reference -> ActivityDefinition MedicinalProductDefinition.operation.type.reference -> ActivityDefinition manufacturingBusinessOperation renamed
2.1. Manufacturer ActivityDefinition.participant.extension[url='http://ema.europa.eu/fhir/extension/manufacturingBusinessOperation'].valueReference.reference (LOC ID) ActivityDefinition.participant.typeReference.identifier[system='http://spor.ema.europa.eu/v1/locations'].value (LOC ID) Extension renamed to match element renamed
2.2. Manufacturing business operation type ActivityDefinition.code.coding[system='http://spor.ema.europa.eu/v1/lists/100000160406'].code ActivityDefinition.code.coding[system='http://spor.ema.europa.eu/v1/lists/100000160406'].code unchanged
2.3. Manufacturing operation start date ActivityDefinition.effectivePeriod.start ActivityDefinition.effectivePeriod.start unchanged
2.4. Manufacturing operation end date ActivityDefinition.effectivePeriod.end ActivityDefinition.effectivePeriod.end unchanged
2.5. Confidentiality indicator MedicinalProductDefinition.manufacturingBusinessOperation.confidentialityIndicator.coding[system='http://spor.ema.europa.eu/v1/lists/200000004983'].code MedicinalProductDefinition.operation.confidentialityIndicator.coding[system='http://spor.ema.europa.eu/v1/lists/200000004983'].code manufacturingBusinessOperation renamed
2.6. Manufacturing authorisation reference number ActivityDefinition <- RegulatedAuthorization[type/coding[code='200000051585']].identifier[system='http://ema.europa.eu/fhir/manufacturingAuthorizationNumber'].value ActivityDefinition <- RegulatedAuthorization[type/coding[code='200000051585']].identifier[system='http://ema.europa.eu/fhir/manufacturingAuthorizationNumber'].value unchanged
2.7. Effective date ActivityDefinition <- RegulatedAuthorization[identifier[system='http://ema.europa.eu/fhir/manufacturingAuthorizationNumber']].validityPeriod.start ActivityDefinition <- RegulatedAuthorization[identifier[system='http://ema.europa.eu/fhir/manufacturingAuthorizationNumber']].validityPeriod.start unchanged
2.8. Medicines Regulatory Agency Organisation ActivityDefinition <- RegulatedAuthorization[identifier[system='http://ema.europa.eu/fhir/manufacturingAuthorizationNumber']].regulator.reference (eg: http://spor.ema.europa.eu/v1/locations/LOC-100020264) ActivityDefinition <- RegulatedAuthorization[identifier[system='http://ema.europa.eu/fhir/manufacturingAuthorizationNumber']].regulator.identifier.value OMS references changed to use reference.identifier
3.1. Regulatory authorisation type MedicinalProductDefinition <- RegulatedAuthorization.type.coding[system='http://spor.ema.europa.eu/v1/lists/220000000060' OR 'http://spor.ema.europa.eu/v1/lists/220000000061'].code MedicinalProductDefinition <- RegulatedAuthorization.type.coding[system='http://spor.ema.europa.eu/v1/lists/220000000060' OR 'http://spor.ema.europa.eu/v1/lists/220000000061'].code unchanged
3.2. Marketing authorisation number MedicinalProductDefinition <- RegulatedAuthorization.identifier[system='http://ema.europa.eu/fhir/MarketingAuthorizationNumber'].value MedicinalProductDefinition <- RegulatedAuthorization.identifier[system='http://ema.europa.eu/fhir/MarketingAuthorizationNumber'].value unchanged
3.3. Country MedicinalProductDefinition <- RegulatedAuthorization.region.coding[system='http://spor.ema.europa.eu/v1/lists/100000000002'].code MedicinalProductDefinition <- RegulatedAuthorization.region.coding[system='http://spor.ema.europa.eu/v1/lists/100000000002'].code unchanged
3.4. Authorisation status MedicinalProductDefinition <- RegulatedAuthorization.status.coding[system='http://spor.ema.europa.eu/v1/lists/100000072049'].code MedicinalProductDefinition <- RegulatedAuthorization.status.coding[system='http://spor.ema.europa.eu/v1/lists/100000072049'].code unchanged
3.5. Authorisation status date MedicinalProductDefinition <- RegulatedAuthorization.statusDate MedicinalProductDefinition <- RegulatedAuthorization.statusDate unchanged
3.6. Date of first authorisation RegulatedAuthorization.relatedDate[type.coding.code='dateOfFirstAuthorisation'].dateDateTime (or RegulatedAuthorization.relatedDate.dateDateTime.extension[url='http://hl7.org/fhir/StructureDefinition/data-absent-reason'].dataAbsentReason) MedicinalProductDefinition <- RegulatedAuthorization.extension[url='http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation'].valueDateTime (or RegulatedAuthorization.extension[url='http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation'].extension[url='http://hl7.org/fhir/StructureDefinition/data-absent-reason'].valueCode) relatedDate became an extension
3.7. International birth date RegulatedAuthorization.relatedDate[type.coding.code='internationalBirthDate'].dateDateTime (or RegulatedAuthorization.relatedDate.dateDateTime.extension[url='http://hl7.org/fhir/StructureDefinition/data-absent-reason'].dataAbsentReason) MedicinalProductDefinition <- RegulatedAuthorization.extension[url='http://ema.europa.eu/fhir/extension/internationalBirthDate'].valueDateTime (or RegulatedAuthorization.extension[url='http://ema.europa.eu/fhir/extension/internationalBirthDate'].extension[url='http://hl7.org/fhir/StructureDefinition/data-absent-reason'].valueCode) relatedDate became an extension
3.8. Marketing authorisation holder (organisation) MedicinalProductDefinition <- RegulatedAuthorization.holder.reference MedicinalProductDefinition <- RegulatedAuthorization.holder.identifier[system='http://spor.ema.europa.eu/v1/locations'].value OMS references changed to use reference.identifier
3.9. (Marketing authorisation) regulator MedicinalProductDefinition <- RegulatedAuthorization.regulator.reference MedicinalProductDefinition <- RegulatedAuthorization.regulator.identifier[system='http://spor.ema.europa.eu/v1/locations'].value OMS references changed to use reference.identifier
3.10.1. Procedure Identifier MedicinalProductDefinition <- RegulatedAuthorization.case.identifier[system='http://ema.europa.eu/fhir/ProcedureIdentifierNumber'].value MedicinalProductDefinition <- RegulatedAuthorization.case.identifier[system='http://ema.europa.eu/fhir/ProcedureIdentifierNumber'].value unchanged
3.10.2. Procedure type – Medicines approval system RegulatedAuthorization[type.coding.system='http://spor.ema.europa.eu/v1/lists/220000000060'][type.coding.code='220000000061'].case.type.coding[system='http://spor.ema.europa.eu/v1/lists/100000154442'].code RegulatedAuthorization[type.coding.system='http://spor.ema.europa.eu/v1/lists/220000000060'][type.coding.code='220000000061'].case.type.coding[system='http://spor.ema.europa.eu/v1/lists/100000154442'].code unchanged
3.10.3. Procedure start date RegulatedAuthorization.case.datePeriod.start RegulatedAuthorization.case.datePeriod.start unchanged
3.10.4. Procedure end date RegulatedAuthorization.case.datePeriod.end RegulatedAuthorization.case.datePeriod.end unchanged
3.10.5.1. Regulatory application Identifier/Number RegulatedAuthorization.case.application.identifier[system='http://ema.europa.eu/fhir/applicationIdentifierNumber'].value RegulatedAuthorization.case.application.identifier[system='http://ema.europa.eu/fhir/applicationIdentifierNumber'].value unchanged
3.10.5.2. Regulatory application type RegulatedAuthorization.case.application.type.coding[system='http://spor.ema.europa.eu/v1/lists/100000155688'].code RegulatedAuthorization.case.application.type.coding[system='http://spor.ema.europa.eu/v1/lists/100000155688'].code unchanged
3.10.5.3. Regulatory Application end date RegulatedAuthorization.case.application[type.coding[system='http://spor.ema.europa.eu/v1/lists/100000155688']].dateDateTime RegulatedAuthorization.case.application[type.coding[system='http://spor.ema.europa.eu/v1/lists/100000155688']].dateDateTime unchanged
5.2. Packaged Medicinal Product Identifier (PCID) PackagedProductDefinition.identifier[system='http://ema.europa.eu/fhir/pcId'].value PackagedProductDefinition.identifier[system='http://ema.europa.eu/fhir/pcId'].value unchanged
5.3. Package description PackagedProductDefinition.description PackagedProductDefinition.description unchanged
5.3.1. Language PackagedProductDefinition.description.extension[url='http://ema.europa.eu/fhir/extension/language'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/100000072057'].code PackagedProductDefinition.description.extension[url='http://ema.europa.eu/fhir/extension/language'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/100000072057'].code unchanged
5.4. Manufacturer Reference PackagedProductDefinition.manufacturer.extension[url='http://ema.europa.eu/fhir/extension/manufacturingBusinessOperation'].valueReference -> ActivityDefinition PackagedProductDefinition.manufacturer.extension[url='http://ema.europa.eu/fhir/extension/operation'].valueReference -> ActivityDefinition Extension renamed to match element renamed
5.5. Pack size PackagedProductDefinition.extension[url='http://ema.europa.eu/fhir/extension/containedItemQuantity'].valueQuantity[system='http://spor.ema.europa.eu/v1/lists/200000000014'].value (and units in .code) PackagedProductDefinition.containedItemQuantity[system='http://spor.ema.europa.eu/v1/lists/200000000014'].value (and units in .code) Extension became containedItemQuantity
5.5.1. Quantity operator PackagedProductDefinition.extension[url='http://ema.europa.eu/fhir/extension/containedItemQuantity'].extension[url='http://ema.europa.eu/fhir/extension/comparator'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/100000000008'].code PackagedProductDefinition.containedItemQuantity.extension[url='http://ema.europa.eu/fhir/extension/comparator'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/100000000008'].code Extension became containedItemQuantity
5.5.1. Quantity operator (when mappable) PackagedProductDefinition.extension[url='http://ema.europa.eu/fhir/extension/containedItemQuantity'].valueQuantity.comparator PackagedProductDefinition.containedItemQuantity.comparator Extension became containedItemQuantity
5.6. Legal status of supply PackagedProductDefinition.legalStatusOfSupply.coding[system='http://spor.ema.europa.eu/v1/lists/100000072051'].code PackagedProductDefinition.legalStatusOfSupply.code.coding[system='http://spor.ema.europa.eu/v1/lists/100000072051'].code legalStatusOfSupply because a class
5.7.1. Marketing status - country PackagedProductDefinition.marketingStatus.country.coding[system='http://spor.ema.europa.eu/v1/lists/100000000002'].code PackagedProductDefinition.marketingStatus.country.coding[system='http://spor.ema.europa.eu/v1/lists/100000000002'].code unchanged
5.7.2. Marketing status - status PackagedProductDefinition.marketingStatus.status.coding[system='http://spor.ema.europa.eu/v1/lists/100000072052'].code PackagedProductDefinition.marketingStatus.status.coding[system='http://spor.ema.europa.eu/v1/lists/100000072052'].code unchanged
5.7.3. (Marketing status) start date PackagedProductDefinition.marketingStatus.dateRange.start PackagedProductDefinition.marketingStatus.dateRange.start unchanged
5.7.4. (Marketing status) end date PackagedProductDefinition.marketingStatus.dateRange.end PackagedProductDefinition.marketingStatus.dateRange.end unchanged
5.7.7.1. Status reason - reason PackagedProductDefinition.marketingStatus.extension[url='http://ema.europa.eu/fhir/extension/reason'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/200000018799'].code PackagedProductDefinition.marketingStatus.extension[url='http://ema.europa.eu/fhir/extension/reason'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/200000018799'].code unchanged
5.6.7.2. Status reason - Restore date PackagedProductDefinition.marketingStatus.restoreDate PackagedProductDefinition.marketingStatus.restoreDate unchanged
5.8.1. Marketing authorisation (Package level) - Reg Auth Type PackagedProductDefinition <- RegulatedAuthorization.type.coding[system='http://spor.ema.europa.eu/v1/lists/220000000060'].code PackagedProductDefinition <- RegulatedAuthorization.type.coding[system='http://spor.ema.europa.eu/v1/lists/220000000060'].code unchanged
5.8.2. Marketing authorisation (Package level) - Mark Auth Nr PackagedProductDefinition <- RegulatedAuthorization.identifier[system='http://ema.europa.eu/fhir/MarketingAuthorizationNumber'].value PackagedProductDefinition <- RegulatedAuthorization.identifier[system='http://ema.europa.eu/fhir/MarketingAuthorizationNumber'].value unchanged
5.8.3. Marketing authorisation (Package level) - Country PackagedProductDefinition <- RegulatedAuthorization.region.coding[system='http://spor.ema.europa.eu/v1/lists/100000000002'].code PackagedProductDefinition <- RegulatedAuthorization.region.coding[system='http://spor.ema.europa.eu/v1/lists/100000000002'].code unchanged
5.8.4. Marketing authorisation (Package level) - Auth Status PackagedProductDefinition <- RegulatedAuthorization.status.coding[system='http://spor.ema.europa.eu/v1/lists/100000072049'].code PackagedProductDefinition <- RegulatedAuthorization.status.coding[system='http://spor.ema.europa.eu/v1/lists/100000072049'].code unchanged
5.8.5. Marketing authorisation (Package level) - Status Date PackagedProductDefinition <- RegulatedAuthorization.statusDate PackagedProductDefinition <- RegulatedAuthorization.statusDate unchanged
5.9.1. Package item (container) type PackagedProductDefinition.package.type.coding[system='http://spor.ema.europa.eu/v1/lists/100000073346'].code PackagedProductDefinition.packaging.type.coding[system='http://spor.ema.europa.eu/v1/lists/100000073346'].code package renamed to packaging
5.9.2. Package item reference(s) PackagedProductDefinition.package.package (level can vary) PackagedProductDefinition.packaging.packaging (level can vary) package renamed to packaging
5.9.3. Manufactured item reference(s) PackagedProductDefinition.package.package.containedItem.item -> ManufacturedItemDefinition PackagedProductDefinition.packaging.packaging.containedItem.item.reference -> ManufacturedItemDefinition package renamed to packaging, and containedItem became a codeableReference
5.9.4. Device reference(s) PackagedProductDefinition.package.package.containedItem.item -> DeviceDefinition PackagedProductDefinition.packaging.packaging.containedItem.item.reference -> DeviceDefinition package renamed to packaging, and containedItem became a codeableReference
5.9.5. Package item (container) quantity PackagedProductDefinition.package.package.containedItem.amountQuantity[system='http://spor.ema.europa.eu/v1/lists/200000000014'].value PackagedProductDefinition.packaging.packaging.containedItem.amount[system='http://spor.ema.europa.eu/v1/lists/200000000014'].value amountQuantity became amount
5.9.5.1. Package item (container) quantity - Operator PackagedProductDefinition.package.package.containedItem.amountQuantity.extension[url='http://ema.europa.eu/fhir/extension/comparator'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/100000000008'].code PackagedProductDefinition.packaging.packaging.containedItem.amount.extension[url='http://ema.europa.eu/fhir/extension/comparator'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/100000000008'].code amountQuantity became amount
5.9.6. Data carrier identifier PackagedProductDefinition.identifier[system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575' or 'http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029' or 'http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030'].value PackagedProductDefinition.identifier[system='http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000167575' or 'http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027029' or 'http://spor.ema.europa.eu/v1/lists/100000000009/terms/200000027030'].value unchanged
5.9.7. Material PackagedProductDefinition.package.material.coding[system='http://spor.ema.europa.eu/v1/lists/200000003199'].code PackagedProductDefinition.packaging.material.coding[system='http://spor.ema.europa.eu/v1/lists/200000003199'].code package renamed to packaging
5.9.8. Manufacturer (New) PackagedProductDefinition.manufacturer.extension[url='http://ema.europa.eu/fhir/extension/manufacturingBusinessOperation'].valueReference -> ActivityDefinition PackagedProductDefinition.manufacturer.extension[url='http://ema.europa.eu/fhir/extension/operation'].valueReference -> ActivityDefinition Extension renamed to match element renamed
5.10.1. Component type PackagedProductDefinition.package.package.type.coding[system='http://spor.ema.europa.eu/v1/lists/100000073346'].code PackagedProductDefinition.packaging.packaging.type.coding[system='http://spor.ema.europa.eu/v1/lists/100000073346'].code package renamed to packaging
5.10.2. Component material PackagedProductDefinition.package.package.material.coding[system='http://spor.ema.europa.eu/v1/lists/200000003199'].code PackagedProductDefinition.packaging.packaging.material.coding[system='http://spor.ema.europa.eu/v1/lists/200000003199'].code package renamed to packaging
5.10.3. Manufacturer (New) PackagedProductDefinition.package.package.manufacturer.extension[url='http://ema.europa.eu/fhir/extension/manufacturingBusinessOperation'].valueReference -> ActivityDefinition PackagedProductDefinition.packaging.packaging.manufacturer.extension[url='http://ema.europa.eu/fhir/extension/operation'].valueReference -> ActivityDefinition package renamed to packaging
5.11.1. Type of medical device used in combination with medicinal product PackagedProductDefinition.package.package.containedItem.item -> DeviceDefinition.extension[url='http://ema.europa.eu/fhir/extension/typeOfCombination'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/200000025965'].code PackagedProductDefinition.packaging.packaging.containedItem.item.reference -> DeviceDefinition.extension[url='http://ema.europa.eu/fhir/extension/typeOfCombination'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/200000025965'].code package renamed to packaging
5.11.5. Medical device quantity PackagedProductDefinition.package.package.containedItem.amountQuantity[system='http://spor.ema.europa.eu/v1/lists/100000110633'].value PackagedProductDefinition.packaging.packaging.containedItem.amount[system='http://spor.ema.europa.eu/v1/lists/100000110633'].value amountQuantity became amount
5.11.5.1. Medical device quantity operator PackagedProductDefinition.package.package.containedItem.amountQuantity.extension[url='http://ema.europa.eu/fhir/extension/comparator'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/100000000008'].code PackagedProductDefinition.packaging.packaging.containedItem.amount.extension[url='http://ema.europa.eu/fhir/extension/comparator'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/100000000008'].code amountQuantity became amount
5.11.5.1. Medical device quantity operator (when mappable) PackagedProductDefinition.package.package.containedItem.amountQuantity.comparator PackagedProductDefinition.packaging.packaging.containedItem.amount.comparator amountQuantity became amount
5.12. Manufactured item PackagedProductDefinition.package.package.containedItem.item -> ManufacturedItemDefinition PackagedProductDefinition.packaging.packaging.containedItem.item.reference -> ManufacturedItemDefinition containedItem became a codeableReference
5.12.1. Unit of presentation ManufacturedItemDefinition.unitOfPresentation.coding[system='http://spor.ema.europa.eu/v1/lists/200000000014'].code ManufacturedItemDefinition.unitOfPresentation.coding[system='http://spor.ema.europa.eu/v1/lists/200000000014'].code unchanged
5.12.2. Manufactured item quantity PackagedProductDefinition.package.package.containedItem.amountQuantity[system='http://spor.ema.europa.eu/v1/lists/100000110633'].value PackagedProductDefinition.packaging.packaging.containedItem.amount[system='http://spor.ema.europa.eu/v1/lists/100000110633'].value amountQuantity became amount
5.12.2.1. Manufactured item quantity - operator PackagedProductDefinition.package.package.containedItem.amountQuantity.extension[url='http://ema.europa.eu/fhir/extension/comparator'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/100000000008'].code PackagedProductDefinition.packaging.packaging.containedItem.amount.extension[url='http://ema.europa.eu/fhir/extension/comparator'].valueCoding[system='http://spor.ema.europa.eu/v1/lists/100000000008'].code amountQuantity became amount
5.12.2.1. Manufactured item quantity - operator (when mappable) PackagedProductDefinition.package.package.containedItem.amountQuantity.comparator PackagedProductDefinition.packaging.packaging.containedItem.amount.comparator package renamed to packaging
5.13.1. Shelf life type PackagedProductDefinition.package.shelfLifeStorage.type.coding[system='http://spor.ema.europa.eu/v1/lists/100000073343'].code PackagedProductDefinition.packaging.shelfLifeStorage.type.coding[system='http://spor.ema.europa.eu/v1/lists/100000073343'].code package renamed to packaging
5.13.2. Shelf life time period and units (value) PackagedProductDefinition.package.shelfLifeStorage.period[system='http://spor.ema.europa.eu/v1/lists/100000110633'].value PackagedProductDefinition.packaging.shelfLifeStorage.periodDuration[system='http://spor.ema.europa.eu/v1/lists/100000110633'].value package renamed to packaging
5.13.2. Shelf life time period and units (units) PackagedProductDefinition.package.shelfLifeStorage.period.unit - the UCUM unit (ex: 'h' for hour) PackagedProductDefinition.packaging.shelfLifeStorage.periodDuration.unit (the UCUM unit (ex: 'h' for hour)) package renamed to packaging
5.13.2. Shelf life time period and units (coded units) PackagedProductDefinition.package.shelfLifeStorage.period.code - the UCUM code (ex: 'a' for year) PackagedProductDefinition.packaging.shelfLifeStorage.periodDuration.code (the UCUM code (ex: 'a' for year)) package renamed to packaging
5.13.2. Shelf life time period and units (coded units system) PackagedProductDefinition.package.shelfLifeStorage.period.system - http://unitsofmeasure.org PackagedProductDefinition.packaging.shelfLifeStorage.periodDuration.system (http://unitsofmeasure.org) package renamed to packaging
5.13.2. Shelf life time period and units (RMS coded units system) PackagedProductDefinition.package.shelfLifeStorage.period.extension[url='http://ema.europa.eu/fhir/extension/codedUnit'].valueCoding.system ('http://spor.ema.europa.eu/v1/lists/100000073343') PackagedProductDefinition.packaging.shelfLifeStorage.periodDuration.extension[url='http://ema.europa.eu/fhir/extension/codedUnit'].valueCoding.system ('http://spor.ema.europa.eu/v1/lists/100000073343') package renamed to packaging
5.13.2. Shelf life time period and units (RMS coded units) PackagedProductDefinition.package.shelfLifeStorage.period.extension[url='http://ema.europa.eu/fhir/extension/codedUnit'].valueCoding.code PackagedProductDefinition.packaging.shelfLifeStorage.periodDuration.extension[url='http://ema.europa.eu/fhir/extension/codedUnit'].valueCoding.code package renamed to packaging
5.13.2. Shelf life time period and units (RMS coded units display) PackagedProductDefinition.package.shelfLifeStorage.period.extension[url='http://ema.europa.eu/fhir/extension/codedUnit'].valueCoding.display PackagedProductDefinition.packaging.shelfLifeStorage.periodDuration.extension[url='http://ema.europa.eu/fhir/extension/codedUnit'].valueCoding.display Element package renamed to packaging
5.13.3. Special precautions for storage PackagedProductDefinition.package.shelfLifeStorage.specialPrecautionsForStorage.coding[system='http://spor.ema.europa.eu/v1/lists/100000073344'].code PackagedProductDefinition.packaging.shelfLifeStorage.specialPrecautionsForStorage.coding[system='http://spor.ema.europa.eu/v1/lists/100000073344'].code package renamed to packaging

Error messages (OperationOutcome.issue)

Severity Code Details.text
Warning BusinessRule Warning: Every packaged product should have at least one Package Size.
ERROR NotSupported Unsupported 'Accept' header. Only 'application/fhir+json' and 'application/fhir+xml' are supported.
ERROR Forbidden Requester not authorized to change product
ERROR Invalid The product was modified on PMS since the last synchronization.
ERROR Invalid Invalid route.Case - sensitive match required.
ERROR Invalid Invalid request. The $everything parameter is not valid.
ERROR Invalid Invalid bundle type
ERROR Invalid Invalid or missing 'meta.profile' values
ERROR Invalid The bundle should contain at least 1 product.
ERROR Invalid The bundle shouldn’t contain more than 1 product
ERROR Invalid The input bundle didn't contain a MedicinalProductDefinition with an ID
ERROR Invalid Entry request node mismatch resource type
ERROR Invalid Every bundle entry must have a request node
ERROR BusinessRule The following PMS Business Rules were not followed: <Rule 1>, <Rule 2>, <Rule 3>, etc…*
ERROR Exception

*Rules:

  • Error: There can't be duplicated manufacturers for the same operation.
  • Error: Every operation must have a manufacturer.
  • Error: Every manufacturer must have at least a manufacturer operation.
  • Error: The activity definition type must be unique per manufacturer loc-id.

Other Information

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.

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