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

Example Bundle: 3. Change pack size (response)

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/PRD417562

domain: 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

-CountryLanguage
*SpainSpanish

operation

id

6519944

Types

-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/12345

subject: 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