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: 2. Change pack size

Generated Narrative: Bundle 290a41c4-5f57-4444-80f7-e2734b193dc3

Profile: http://ema.europa.eu/fhir/definition/esmp/Bundle-variation/0.1.1

Bundle 290a41c4-5f57-4444-80f7-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

Request:

PUT 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: 40(unit 200000002152 from http://spor.ema.europa.eu/v1/lists/200000000014) (Details: Units Of Presentation code200000002152 = 'Tablet')

description:

5MG/120MG PROLONGED RELEASE TABLET

Request:

PUT PackagedProductDefinition/7868766