http://hl7.org/fhir/StructureDefinition/MedicinalProductAuthorization|4.0.1

description: The regulatory authorization of a medicinal product.
derivation: specialization
name: MedicinalProductAuthorization
type: MedicinalProductAuthorization
elements:
  dataExclusivityPeriod: {short: A period of time after authorization before generic product applicatiosn can be submitted, isSummary: true, index: 8}
  restoreDate: {short: The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored, isSummary: true, index: 6}
  jurisdiction: {short: Jurisdiction within a country, array: true, isSummary: true, index: 3}
  jurisdictionalAuthorization:
    short: Authorization in areas within a country
    array: true
    isSummary: true
    index: 12
    elements:
      identifier: {short: The assigned number for the marketing authorization, array: true, isSummary: true, index: 13}
      country: {short: Country of authorization, isSummary: true, index: 14}
      jurisdiction: {short: Jurisdiction within a country, array: true, isSummary: true, index: 15}
      legalStatusOfSupply: {short: The legal status of supply in a jurisdiction or region, isSummary: true, index: 16}
      validityPeriod: {short: The start and expected end date of the authorization, isSummary: true, index: 17}
  procedure:
    short: The regulatory procedure for granting or amending a marketing authorization
    isSummary: true
    index: 20
    elements:
      identifier: {short: Identifier for this procedure, isSummary: true, index: 21}
      type: {short: Type of procedure, isSummary: true, index: 22}
      date:
        short: Date of procedure
        choices: []
        isSummary: true
        index: 24
      application:
        elementReference: ['http://hl7.org/fhir/StructureDefinition/MedicinalProductAuthorization', elements, procedure]
        short: Applcations submitted to obtain a marketing authorization
        array: true
        isSummary: true
        index: 25
    required: [type]
  legalBasis: {short: The legal framework against which this authorization is granted, isSummary: true, index: 11}
  validityPeriod: {short: 'The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format', isSummary: true, index: 7}
  regulator: {short: Medicines Regulatory Agency, isSummary: true, index: 19}
  status: {short: The status of the marketing authorization, isSummary: true, index: 4}
  identifier: {short: 'Business identifier for the marketing authorization, as assigned by a regulator', array: true, isSummary: true, index: 0}
  statusDate: {short: The date at which the given status has become applicable, isSummary: true, index: 5}
  dateOfFirstAuthorization: {short: The date when the first authorization was granted by a Medicines Regulatory Agency, isSummary: true, index: 9}
  internationalBirthDate: {short: Date of first marketing authorization for a company's new medicinal product in any country in the World, isSummary: true, index: 10}
  holder: {short: Marketing Authorization Holder, isSummary: true, index: 18}
  country: {short: The country in which the marketing authorization has been granted, array: true, isSummary: true, index: 2}
  subject: {short: The medicinal product that is being authorized, isSummary: true, index: 1}
class: resource
kind: resource
url: http://hl7.org/fhir/StructureDefinition/MedicinalProductAuthorization
base: http://hl7.org/fhir/StructureDefinition/DomainResource
version: 4.0.1