R4 Ballot #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.5.0: R4 Ballot #2). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions

Medicinalproductauthorization-example

Biomedical Research and Regulation Work Group

Maturity Level: N/A

Ballot Status: Informative

Compartments: Not linked to any defined compartments

This is the narrative for the resource. See also the XML, JSON or Turtle format. This example conforms to the profile MedicinalProductAuthorization.

Generated Narrative with Details

id: example

identifier: EU/1/11/999/001

country: EU (Details : {http://ema.europa.eu/example/country code 'EU' = 'EU)

legalStatusOfSupply: Subjecttomedicalprescription (Details : {http://ema.europa.eu/example/legalstatusofsupply code 'Subjecttomedicalprescription' = 'Subjecttomedicalprescription)

status: active (Details : {http://ema.europa.eu/example/authorisationstatus code 'active' = 'active)

statusDate: 14/01/2015

validityPeriod: 16/08/2015 --> 20/05/2020

dataExclusivityPeriod: 15/08/2010 --> 15/08/2020

dateOfFirstAuthorization: 15/08/2010

internationalBirthDate: 15/08/2010

jurisdictionalAuthorization
identifier: 123-456-789
country: NO (Details : {http://ema.europa.eu/example/countryCode code 'NO' = 'NO)

jurisdictionalAuthorization
identifier: 123-456-123
country: NO (Details : {http://ema.europa.eu/example/countryCode code 'NO' = 'NO)

holder: Organization/example

regulator: Organization/example

procedure
identifier: EMEA/H/C/009999/IA/0099/G
type: VariationTypeIA (Details : {http://ema.europa.eu/example/marketingAuthorisationProcedureType code 'VariationTypeIA' = 'VariationTypeIA)
date: 02/08/2015 --> 21/08/2015
Applications
-
*

Other examples that reference this example:

MedicinalProduct/General

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.