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: 4. Add manufacturing operation

Generated Narrative: Bundle e4760773-4635-4f49-8f3f-4d085f049199

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 e4760773-4635-4f49-8f3f-4d085f049199 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/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-response

confidentialityIndicator: Public

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/PRD417562

packageFor: Bundle: type = searchset

status: Nullified

containedItemQuantity: 20(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/123456

Resource ActivityDefinition:

Id: 123456
Effective Period: 2025-03-31..
Code:

system: http://spor.ema.europa.eu/v1/lists/100000160406

code: 100000160480

Response:

200
Location = ActivityDefinition/123456

Entry 4 - fullUrl = http://ema.europa.eu/example/api/RegulatedAuthorization/345678

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization 345678

identifier: http://ema.europa.eu/fhir/manufacturingAuthorizationNumber/12345

subject: Bundle: type = transaction-response

type: Manufacturing Authorisation

validityPeriod: 2025-03-31 --> (ongoing)

regulator: Finnish Medicines Agency (Identifier: http://spor.ema.europa.eu/v1/locations/LOC-100000015)

Response:

200
Location = RegulatedAuthorization/345678

Entry 5 - 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 6 - fullUrl = http://ema.europa.eu/example/api/RegulatedAuthorization/6756012

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization 6756012

identifier: http://ema.europa.eu/fhir/MarketingAuthorizationNumber/62.102

subject: 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 7 - fullUrl = http://ema.europa.eu/example/api/RegulatedAuthorization/6362767

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization 6362767

identifier: http://ema.europa.eu/fhir/MarketingAuthorizationNumber/62.102

subject: 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 8 - fullUrl = http://ema.europa.eu/example/api/RegulatedAuthorization/6094279

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization 6094279

subject: This is a dummy resource, to make the PMS examples links resolve for QA purposes - but these are not supported in the API currently

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