description: The regulatory authorization of a medicinal product, device or process.
package_name: hl7.fhir.r5.core
derivation: specialization
name: RegulatedAuthorization
type: RegulatedAuthorization
elements:
  description: {type: markdown, short: General textual supporting information, isSummary: true, index: 3}
  indication:
    short: Condition for which the medicinal use applies
    isSummary: true
    choices: [indicationCodeableConcept, indicationReference]
    index: 9
  jurisdictionalAuthorization:
    short: Authorization in areas within a country
    refers: ['http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization']
    type: Reference
    array: true
    isSummary: true
    index: 20
  basis: {type: CodeableConcept, short: 'The legal or regulatory framework against which this authorization is granted, or other reasons for it', isSummary: true, array: true, index: 13}
  type: {type: CodeableConcept, short: 'Overall type of this authorization, for example drug marketing approval, orphan drug designation', isSummary: true, index: 2}
  validityPeriod: {type: Period, 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}
  region: {type: CodeableConcept, short: 'The region (country, jurisdiction etc.) in which the marketing authorization has been granted', isSummary: true, array: true, index: 4}
  intendedUse: {type: CodeableConcept, short: 'The intended use of the product, e.g. prevention, treatment', isSummary: true, index: 12}
  regulator:
    short: Medicines Regulatory Agency
    refers: ['http://hl7.org/fhir/StructureDefinition/Organization']
    type: Reference
    isSummary: true
    index: 22
  status: {type: CodeableConcept, short: The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications, isSummary: true, index: 5}
  case:
    type: BackboneElement
    short: The case or regulatory procedure for granting or amending a marketing authorization
    isSummary: true
    index: 23
    elements:
      identifier: {type: Identifier, short: Identifier by which this case can be referenced, isSummary: true, index: 24}
      type: {type: CodeableConcept, short: The defining type of case, isSummary: true, index: 25}
      status: {type: CodeableConcept, short: The status associated with the case, isSummary: true, index: 26}
      date:
        short: Relevant date for this of case
        isSummary: true
        choices: [datePeriod, dateDateTime]
        index: 28
      datePeriod: {short: Relevant date for this of case, type: Period, choiceOf: date, isSummary: true, index: 29}
      dateDateTime: {short: Relevant date for this of case, type: dateTime, choiceOf: date, isSummary: true, index: 30}
      application:
        short: Applcations submitted to obtain a marketing authorization. Steps within the longer running case or procedure
        isSummary: true
        elementReference: ['http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization', elements, case]
        array: true
        index: 31
  identifier: {type: Identifier, short: 'Business identifier for the authorization, typically assigned by the authorizing body', isSummary: true, array: true, index: 0}
  statusDate: {type: dateTime, short: The date at which the given status became applicable, isSummary: true, index: 6}
  indicationCodeableConcept: {short: Condition for which the medicinal use applies, type: CodeableConcept, choiceOf: indication, isSummary: true, index: 10}
  holder:
    short: Marketing Authorization Holder
    refers: ['http://hl7.org/fhir/StructureDefinition/Organization']
    type: Reference
    isSummary: true
    index: 21
  relatedDate:
    type: BackboneElement
    short: Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on
    isSummary: true
    array: true
    index: 14
    elements:
      date:
        short: Another date associated with the authorization
        isSummary: true
        choices: [datePeriod, dateDateTime]
        index: 16
      datePeriod: {short: Another date associated with the authorization, type: Period, choiceOf: date, isSummary: true, index: 17}
      dateDateTime: {short: Another date associated with the authorization, type: dateTime, choiceOf: date, isSummary: true, index: 18}
      type: {type: CodeableConcept, short: 'Type of this date, for example the data exclusitity period for a medicinal product', isSummary: true, index: 19}
    required: [dateDateTime, datePeriod, type, date]
  indicationReference:
    short: Condition for which the medicinal use applies
    refers: ['http://hl7.org/fhir/StructureDefinition/ClinicalUseIssue']
    type: Reference
    choiceOf: indication
    isSummary: true
    index: 11
  subject:
    short: The type of product or service that is being authorized
    refers: ['http://hl7.org/fhir/StructureDefinition/ActivityDefinition', 'http://hl7.org/fhir/StructureDefinition/DeviceDefinition', 'http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition', 'http://hl7.org/fhir/StructureDefinition/ObservationDefinition', 'http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition', 'http://hl7.org/fhir/StructureDefinition/PlanDefinition', 'http://hl7.org/fhir/StructureDefinition/ResearchStudy']
    type: Reference
    isSummary: true
    index: 1
package_version: 4.4.0
class: resource
kind: resource
url: http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization
base: http://hl7.org/fhir/StructureDefinition/DomainResource
version: 4.4.0