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 ed38e7e5-235e-460e-b292-f6c220622d1c
Profiles: http://ema.europa.eu/fhir/definition/esmp/Bundle-variation/0.1.1
, http://ema.europa.eu/fhir/definition/fhir-adapter/1.0.0.5
Bundle ed38e7e5-235e-460e-b292-f6c220622d1c of type transaction-response
Entry 1 - fullUrl = http://ema.europa.eu/example/api/MedicinalProductDefinition/600000709068
Resource MedicinalProductDefinition:
Generated Narrative: MedicinalProductDefinition 600000709068
version: 4
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
Response:
200 Location = MedicinalProductDefinition/600000709068
Entry 2 - fullUrl = http://ema.europa.eu/example/api/PackagedProductDefinition/7868766
Resource PackagedProductDefinition:
Generated Narrative: PackagedProductDefinition 7868766
identifier:
http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665
/PRD417562packageFor: Bundle: type = searchset
status: Nullified
containedItemQuantity: 40(unit 200000002152 from http://spor.ema.europa.eu/v1/lists/200000000014) (Details: Units Of Presentation code200000002152 = 'Tablet')
description:
5MG/120MG PROLONGED RELEASE TABLET
Response:
200 Location = PackagedProductDefinition/7868766
Entry 3 - fullUrl = http://ema.europa.eu/example/api/ActivityDefinition/7371703
Resource ActivityDefinition:
Id: 7371703 Effective Period: 2024-12-01.. Code: system: http://spor.ema.europa.eu/v1/lists/100000160406
code: 100000160478
Response:
200 Location = ActivityDefinition/7371703
Entry 4 - fullUrl = http://ema.europa.eu/example/api/RegulatedAuthorization/6756012
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization 6756012
identifier:
http://ema.europa.eu/fhir/MarketingAuthorizationNumber
/62.102subject: Bundle: type = searchset
type: Marketing Authorisation
region: Spain
status: Not valid - Superseded by marketing authorisation transfer
statusDate: 2025-02-18 00:00:00+0000
holder: Kern Pharma S.L. (Identifier:
http://spor.ema.europa.eu/v1/locations
/LOC-100002956)regulator: ES (Identifier:
http://spor.ema.europa.eu/v1/locations
/ES)Cases
Type National Procedure
Response:
200 Location = RegulatedAuthorization/6756012
Entry 5 - fullUrl = http://ema.europa.eu/example/api/RegulatedAuthorization/6362767
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization 6362767
identifier:
http://ema.europa.eu/fhir/MarketingAuthorizationNumber
/62.102subject: Bundle: type = searchset
type: Marketing Authorisation
region: Spain
status: Not valid - Superseded by marketing authorisation transfer
statusDate: 2025-02-18 00:00:00+0000
Response:
200 Location = RegulatedAuthorization/6362767
Entry 6 - fullUrl = http://ema.europa.eu/example/api/RegulatedAuthorization/6094279
Resource RegulatedAuthorization:
Generated Narrative: RegulatedAuthorization 6094279
type: Manufacturing Authorisation
validityPeriod: 2024-12-01 --> (ongoing)
regulator: Finnish Medicines Agency (Identifier:
http://spor.ema.europa.eu/v1/locations
/LOC-100000015)
Response:
200 Location = RegulatedAuthorization/6094279