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
Generated Narrative: Bundle 490a41c4-5f57-4444-80f7-e2734b193dc3
Profile: http://ema.europa.eu/fhir/definition/esmp/Bundle-variation/0.1.1
Bundle 490a41c4-5f57-4444-80f7-e2734b193dc3 of type transaction
Entry 1 - fullUrl = http://ema.europa.eu/example/api/MedicinalProductDefinition/600000709068
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition 600000709068
version: 3
Authorised Dose Form: Pharmaceutical Dose Form 100000073683: Prolonged-release tablet
identifier:
http://spor.azure-api.net/pms/api/v2
/6055417,http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665
/PRD417562domain: Human use
status: Nullified
combinedPharmaceuticalDoseForm: Prolonged-release tablet
additionalMonitoringIndicator: False
pediatricUseIndicator: True
classification: 100000098024, Full application (Article 8(3) of Directive No 2001/83/EC), Other
attachedDocument: DocumentReference: status = current
masterFile: DocumentReference: status = current
contact
type: Pharmacovigilance Enquiry Information
contact: Organization Dummmy Organization
contact
type: Qualified Person in the EEA for Pharmacovigilance
contact: PractitionerRole
name
productName: StopCold 5 mg/120 mg comprimidos de liberación prolongada.
part
part: StopCold
type: Invented name part
part
part: 5 MG/120 MG
type: Strength part
part
part: COMPRIMIDOS DE LIBERACIÓN PROLONGADA
type: Pharmaceutical dose form part
Usages
Country Language Spain Spanish operation
id
6519944Types
Reference This is a dummy resource, to make the PMS examples links resolve for QA purposes - but these are not supported in the API currently confidentialityIndicator: Confidential
operation
Types
Reference Bundle: type = transaction confidentialityIndicator: Public
Request:
PUT MedicinalProductDefinition/600000709068
Entry 2 - fullUrl = urn:uuid:a57ef872-40cf-4bc8-a486-211ba46f367f
Resource ActivityDefinition:
Effective Period: 2025-03-31.. Code: system: http://spor.ema.europa.eu/v1/lists/100000160406
code: 100000160480
Request:
POST ActivityDefinition
Entry 3 - fullUrl = urn:uuid:34aac3e5-6c44-45fd-9a57-4c3cb638a13c
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization
identifier:
http://ema.europa.eu/fhir/manufacturingAuthorizationNumber
/12345subject: Bundle: type = transaction
type: Manufacturing Authorisation
validityPeriod: 2025-03-31 --> (ongoing)
regulator: Finnish Medicines Agency (Identifier:
http://spor.ema.europa.eu/v1/locations
/LOC-100000015)
Request:
POST RegulatedAuthorization