description: Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.
package_name: hl7.fhir.r5.examples
derivation: specialization
name: RegulatedAuthorization
type: RegulatedAuthorization
elements:
  description: {isModifier: false, short: General textual supporting information, type: markdown, mustSupport: false, isSummary: true, index: 3}
  indication: {isModifier: false, short: Condition for which the use of the regulated product  applies, type: CodeableReference, mustSupport: false, isSummary: true, index: 8}
  jurisdictionalAuthorization:
    isModifier: false
    short: Authorization in areas within a country
    refers: ['http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization']
    type: Reference
    mustSupport: false
    array: true
    isSummary: true
    index: 17
  basis: {isModifier: false, short: 'The legal or regulatory framework against which this authorization is granted, or other reasons for it', type: CodeableConcept, mustSupport: false, array: true, isSummary: true, index: 10}
  type: {isModifier: false, short: 'Overall type of this authorization, for example drug marketing approval, orphan drug designation', type: CodeableConcept, mustSupport: false, isSummary: true, index: 2}
  validityPeriod: {isModifier: false, short: 'The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date', type: Period, mustSupport: false, isSummary: true, index: 7}
  region: {isModifier: false, short: 'The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted', type: CodeableConcept, mustSupport: false, array: true, isSummary: true, index: 4}
  intendedUse: {isModifier: false, short: 'The intended use of the product, e.g. prevention, treatment', type: CodeableConcept, mustSupport: false, isSummary: true, index: 9}
  regulator:
    isModifier: false
    short: The regulatory authority or authorizing body granting the authorization
    refers: ['http://hl7.org/fhir/StructureDefinition/Organization']
    type: Reference
    mustSupport: false
    isSummary: true
    index: 19
  status: {isModifier: false, short: The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications, type: CodeableConcept, mustSupport: false, isSummary: true, index: 5}
  case:
    isModifier: false
    short: 'The case or regulatory procedure for granting or amending a marketing authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)'
    type: BackboneElement
    mustSupport: false
    isSummary: true
    index: 21
    elements:
      identifier: {isModifier: false, short: Identifier by which this case can be referenced, type: Identifier, mustSupport: false, isSummary: true, index: 22}
      type: {isModifier: false, short: The defining type of case, type: CodeableConcept, mustSupport: false, isSummary: true, index: 23}
      status: {isModifier: false, short: The status associated with the case, type: CodeableConcept, mustSupport: false, isSummary: true, index: 24}
      date:
        isModifier: false
        short: Relevant date for this of case
        mustSupport: false
        choices: [datePeriod, dateDateTime]
        isSummary: true
        index: 26
      datePeriod: {isModifier: false, short: Relevant date for this of case, type: Period, mustSupport: false, choiceOf: date, isSummary: true, index: 27}
      dateDateTime: {isModifier: false, short: Relevant date for this of case, type: dateTime, mustSupport: false, choiceOf: date, isSummary: true, index: 28}
      application:
        elementReference: ['http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization', elements, case]
        isModifier: false
        short: Applications submitted to obtain a marketing authorization. Steps within the longer running case or procedure
        mustSupport: false
        array: true
        isSummary: true
        index: 29
  identifier: {isModifier: false, short: 'Business identifier for the authorization, typically this is assigned by the authorizing body', type: Identifier, mustSupport: false, array: true, isSummary: true, index: 0}
  statusDate: {isModifier: false, short: The date at which the current status was assigned, type: dateTime, mustSupport: false, isSummary: true, index: 6}
  holder:
    isModifier: false
    short: The organization that holds the granted authorization
    refers: ['http://hl7.org/fhir/StructureDefinition/Organization']
    type: Reference
    mustSupport: false
    isSummary: true
    index: 18
  attachedDocument:
    isModifier: false
    short: Additional information or supporting documentation about the authorization
    refers: ['http://hl7.org/fhir/StructureDefinition/DocumentReference']
    type: Reference
    mustSupport: false
    array: true
    isSummary: true
    index: 20
  relatedDate:
    isModifier: false
    short: Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on
    index: 11
    type: BackboneElement
    mustSupport: false
    array: true
    elements:
      date:
        isModifier: false
        short: Another date associated with the authorization
        mustSupport: false
        choices: [datePeriod, dateDateTime]
        isSummary: true
        index: 13
      datePeriod: {isModifier: false, short: Another date associated with the authorization, type: Period, mustSupport: false, choiceOf: date, isSummary: true, index: 14}
      dateDateTime: {isModifier: false, short: Another date associated with the authorization, type: dateTime, mustSupport: false, choiceOf: date, isSummary: true, index: 15}
      type: {isModifier: false, short: 'The meaning of the related date for a regulated product, treatment, facility or activity.  As an example, the data exclusivity period for a regulated product', type: CodeableConcept, mustSupport: false, isSummary: true, index: 16}
    required: [dateDateTime, datePeriod, type, date]
    isSummary: true
  subject:
    isModifier: false
    short: The type of regulated product, treatment, facility or activity that is being authorized
    refers: ['http://hl7.org/fhir/StructureDefinition/ActivityDefinition', 'http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct', 'http://hl7.org/fhir/StructureDefinition/DeviceDefinition', 'http://hl7.org/fhir/StructureDefinition/Location', 'http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition', 'http://hl7.org/fhir/StructureDefinition/NutritionProduct', 'http://hl7.org/fhir/StructureDefinition/ObservationDefinition', 'http://hl7.org/fhir/StructureDefinition/Organization', 'http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition', 'http://hl7.org/fhir/StructureDefinition/PlanDefinition', 'http://hl7.org/fhir/StructureDefinition/Practitioner', 'http://hl7.org/fhir/StructureDefinition/ResearchStudy', 'http://hl7.org/fhir/StructureDefinition/SubstanceDefinition']
    type: Reference
    mustSupport: false
    isSummary: true
    index: 1
package_version: 4.6.0
class: resource
kind: resource
url: http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization
base: http://hl7.org/fhir/StructureDefinition/DomainResource
version: 4.6.0