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Medicinalproductauthorization-example

Biomedical Research and Regulation Work GroupMaturity Level: N/ABallot Status: InformativeCompartments: 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: 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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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.