Medicinalproductauthorization-example

Biomedical Research and Regulation Work Group

Maturity Level: N/A

Standards 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)

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

statusDate: Jan 14, 2015

validityPeriod: Aug 16, 2015 --> May 20, 2020

dataExclusivityPeriod: Aug 15, 2010 --> Aug 15, 2020

dateOfFirstAuthorization: Aug 15, 2010

internationalBirthDate: Aug 15, 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: Aug 2, 2015 --> Aug 21, 2015
Applications
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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.