Release 5 Ballot

This page is part of the FHIR Specification (v5.0.0-ballot: FHIR R5 Ballot Preview). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

15.6 Resource RegulatedAuthorization - Content

Biomedical Research and Regulation Work GroupMaturity Level: 2 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

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.

15.6.1 Scope and Usage

For an overview of this resource and others in the Medication Definition domain, also see the module page

RegulatedAuthorization is a resource covering the authorization of a type of regulated product, treatment, facility or activity.

Regulated products include animal and human drugs, devices, biologically derived, radiation-emitting, and nutritional products, software, etc. which are subject to local, regional or international legislation for their use.

Regulated treatments include emergency use of a regulated product, sedation/anesthesia or radiation therapy.

Regulated facilities include the storage, manufacturing, distribution, or any other regulated aspect for regulated products

Regulated activities include conducting a Clinical Trial e.g. either parts or the whole of a certain trial. Marketing regulated products to patients in general, manufacturing regulated products. Storage or distribution of controlled substances. Recording whether a laboratory test is approved for use by a regulator, etc.

This is a general authorization and is not related to any particular instance of use or any patient, therefore the following is out of scope for the resource:

Security authorizations - This resource is not directly related to "authorizations" as in permissions for users and actions in a security context.

Consent - which represents the choices and rights of an individual. Although there is a general legal right to give or withhold consent, consent is a record of a specific patients choice. This differs from the high level authorization of class of events or products to be used in general (within some legal framework), for any patient. The concepts are very broadly similar in concept, but are very different use cases in software terms, with little likelihood of confusion or overlap of implementation and properties.

Contract - a contract is a legal agreement between two entities about a specific arrangement. It is optionally entered into by the parties, but then binding. This is different from a generalised legal framework (law) that exists (e.g. legislation about controlled drugs), but is then applied to a series of instances of, say, drug types and organizations. A contract is more similar to the drug legislation itself, rather than the applications of it. However the legal frameworks themselves are mostly static and are not generally represented in clinical systems.

Authorizations of drugs - although the word is the same, the common concept of a physician authorizing a patient to have a certain drug (prescribing) is very different from the legal authorization to use that drug in a territory ("marketing authorization"). The context usually makes it very clear which is which (RegulatedAuthorization vs. MedicationRequest).

15.6.2 References to this Resource

No references for this Resource.

15.6.3 Resource Content

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization TUDomainResourceRegulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness identifier for the authorization, typically assigned by the authorizing body

... subject Σ0..*Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | ManufacturedItemDefinition | Ingredient | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location)The product type, treatment, facility or activity that is being authorized

... type Σ0..1CodeableConceptOverall type of this authorization, for example drug marketing approval, orphan drug designation
RegulatedAuthorizationType (Example)
... region Σ0..*CodeableConceptThe territory in which the authorization has been granted
Jurisdiction (Example)

... status Σ0..1CodeableConceptThe status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
PublicationStatus (Preferred)
... statusDate Σ0..1dateTimeThe date at which the current status was assigned
... validityPeriod Σ0..1PeriodThe time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
... indication Σ0..*CodeableReference(ClinicalUseDefinition)Condition for which the use of the regulated product applies

... intendedUse Σ0..1CodeableConceptThe intended use of the product, e.g. prevention, treatment
ProductIntendedUse (Preferred)
... basis Σ0..*CodeableConceptThe legal/regulatory framework or reasons under which this authorization is granted
RegulatedAuthorizationBasis (Example)

... holder Σ0..1Reference(Organization)The organization that has been granted this authorization, by the regulator
... regulator Σ0..1Reference(Organization)The regulatory authority or authorizing body granting the authorization
... attachedDocument Σ0..*Reference(DocumentReference)Additional information or supporting documentation about the authorization

... case Σ0..1BackboneElementThe case or regulatory procedure for granting or amending a regulated 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)
.... identifier Σ0..1IdentifierIdentifier by which this case can be referenced
.... type Σ0..1CodeableConceptThe defining type of case
RegulatedAuthorizationCaseType (Example)
.... status Σ0..1CodeableConceptThe status associated with the case
PublicationStatus (Preferred)
.... date[x] Σ0..1Relevant date for this case
..... datePeriodPeriod
..... dateDateTimedateTime
.... application Σ0..*see caseApplications submitted to obtain a regulated authorization. Steps within the longer running case or procedure


doco Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

RegulatedAuthorization (DomainResource)Business identifier for the authorization, typically assigned by the authorizing bodyidentifier : Identifier [0..*]The product type, treatment, facility or activity that is being authorizedsubject : Reference [0..*] « MedicinalProductDefinition| BiologicallyDerivedProduct|NutritionProduct| PackagedProductDefinition|ManufacturedItemDefinition| Ingredient|SubstanceDefinition|DeviceDefinition|ResearchStudy| ActivityDefinition|PlanDefinition|ObservationDefinition| Practitioner|Organization|Location »Overall type of this authorization, for example drug marketing approval, orphan drug designationtype : CodeableConcept [0..1] « null (Strength=Example)RegulatedAuthorizationType?? »General textual supporting informationdescription : markdown [0..1]The territory (e.g., country, jurisdiction etc.) in which the authorization has been grantedregion : CodeableConcept [0..*] « null (Strength=Example)Jurisdiction ValueSet?? »The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applicationsstatus : CodeableConcept [0..1] « null (Strength=Preferred)PublicationStatus? »The date at which the current status was assignedstatusDate : dateTime [0..1]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 datevalidityPeriod : Period [0..1]Condition for which the use of the regulated product appliesindication : CodeableReference [0..*] « ClinicalUseDefinition »The intended use of the product, e.g. prevention, treatment, diagnosisintendedUse : CodeableConcept [0..1] « null (Strength=Preferred)ProductIntendedUse? »The legal or regulatory framework against which this authorization is granted, or other reasons for itbasis : CodeableConcept [0..*] « null (Strength=Example)RegulatedAuthorizationBasis?? »The organization that has been granted this authorization, by some authoritative body (the 'regulator')holder : Reference [0..1] « Organization »The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etcregulator : Reference [0..1] « Organization »Additional information or supporting documentation about the authorizationattachedDocument : Reference [0..*] « DocumentReference »CaseIdentifier by which this case can be referencedidentifier : Identifier [0..1]The defining type of casetype : CodeableConcept [0..1] « null (Strength=Example)RegulatedAuthorizationCaseType?? »The status associated with the casestatus : CodeableConcept [0..1] « null (Strength=Preferred)PublicationStatus? »Relevant date for this casedate[x] : DataType [0..1] « Period|dateTime »A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization processapplication[0..*]The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)case[0..1]

XML Template

<RegulatedAuthorization xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Business identifier for the authorization, typically assigned by the authorizing body --></identifier>
 <subject><!-- 0..* Reference(ActivityDefinition|BiologicallyDerivedProduct|
   DeviceDefinition|Ingredient|Location|ManufacturedItemDefinition|
   MedicinalProductDefinition|NutritionProduct|ObservationDefinition|
   Organization|PackagedProductDefinition|PlanDefinition|Practitioner|
   ResearchStudy|SubstanceDefinition) The product type, treatment, facility or activity that is being authorized --></subject>
 <type><!-- 0..1 CodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation --></type>
 <description value="[markdown]"/><!-- 0..1 General textual supporting information -->
 <region><!-- 0..* CodeableConcept The territory in which the authorization has been granted --></region>
 <status><!-- 0..1 CodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications --></status>
 <statusDate value="[dateTime]"/><!-- 0..1 The date at which the current status was assigned -->
 <validityPeriod><!-- 0..1 Period The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date --></validityPeriod>
 <indication><!-- 0..* CodeableReference(ClinicalUseDefinition) Condition for which the use of the regulated product applies --></indication>
 <intendedUse><!-- 0..1 CodeableConcept The intended use of the product, e.g. prevention, treatment --></intendedUse>
 <basis><!-- 0..* CodeableConcept The legal/regulatory framework or reasons under which this authorization is granted --></basis>
 <holder><!-- 0..1 Reference(Organization) The organization that has been granted this authorization, by the regulator --></holder>
 <regulator><!-- 0..1 Reference(Organization) The regulatory authority or authorizing body granting the authorization --></regulator>
 <attachedDocument><!-- 0..* Reference(DocumentReference) Additional information or supporting documentation about the authorization --></attachedDocument>
 <case>  <!-- 0..1 The case or regulatory procedure for granting or amending a regulated 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) -->
  <identifier><!-- 0..1 Identifier Identifier by which this case can be referenced --></identifier>
  <type><!-- 0..1 CodeableConcept The defining type of case --></type>
  <status><!-- 0..1 CodeableConcept The status associated with the case --></status>
  <date[x]><!-- 0..1 Period|dateTime Relevant date for this case --></date[x]>
  <application><!-- 0..* Content as for RegulatedAuthorization.case Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure --></application>
 </case>
</RegulatedAuthorization>

JSON Template

{doco
  "resourceType" : "RegulatedAuthorization",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business identifier for the authorization, typically assigned by the authorizing body
  "subject" : [{ Reference(ActivityDefinition|BiologicallyDerivedProduct|
   DeviceDefinition|Ingredient|Location|ManufacturedItemDefinition|
   MedicinalProductDefinition|NutritionProduct|ObservationDefinition|
   Organization|PackagedProductDefinition|PlanDefinition|Practitioner|
   ResearchStudy|SubstanceDefinition) }], // The product type, treatment, facility or activity that is being authorized
  "type" : { CodeableConcept }, // Overall type of this authorization, for example drug marketing approval, orphan drug designation
  "description" : "<markdown>", // General textual supporting information
  "region" : [{ CodeableConcept }], // The territory in which the authorization has been granted
  "status" : { CodeableConcept }, // The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
  "statusDate" : "<dateTime>", // The date at which the current status was assigned
  "validityPeriod" : { Period }, // The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
  "indication" : [{ CodeableReference(ClinicalUseDefinition) }], // Condition for which the use of the regulated product applies
  "intendedUse" : { CodeableConcept }, // The intended use of the product, e.g. prevention, treatment
  "basis" : [{ CodeableConcept }], // The legal/regulatory framework or reasons under which this authorization is granted
  "holder" : { Reference(Organization) }, // The organization that has been granted this authorization, by the regulator
  "regulator" : { Reference(Organization) }, // The regulatory authority or authorizing body granting the authorization
  "attachedDocument" : [{ Reference(DocumentReference) }], // Additional information or supporting documentation about the authorization
  "case" : { // The case or regulatory procedure for granting or amending a regulated 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)
    "identifier" : { Identifier }, // Identifier by which this case can be referenced
    "type" : { CodeableConcept }, // The defining type of case
    "status" : { CodeableConcept }, // The status associated with the case
    // date[x]: Relevant date for this case. One of these 2:
    "datePeriod" : { Period },
    "dateDateTime" : "<dateTime>",
    "application" : [{ Content as for RegulatedAuthorization.case }] // Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
  }
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:RegulatedAuthorization;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:RegulatedAuthorization.identifier [ Identifier ], ... ; # 0..* Business identifier for the authorization, typically assigned by the authorizing body
  fhir:RegulatedAuthorization.subject [ Reference(ActivityDefinition|BiologicallyDerivedProduct|DeviceDefinition|Ingredient|
  Location|ManufacturedItemDefinition|MedicinalProductDefinition|
  NutritionProduct|ObservationDefinition|Organization|PackagedProductDefinition|
  PlanDefinition|Practitioner|ResearchStudy|SubstanceDefinition) ], ... ; # 0..* The product type, treatment, facility or activity that is being authorized
  fhir:RegulatedAuthorization.type [ CodeableConcept ]; # 0..1 Overall type of this authorization, for example drug marketing approval, orphan drug designation
  fhir:RegulatedAuthorization.description [ markdown ]; # 0..1 General textual supporting information
  fhir:RegulatedAuthorization.region [ CodeableConcept ], ... ; # 0..* The territory in which the authorization has been granted
  fhir:RegulatedAuthorization.status [ CodeableConcept ]; # 0..1 The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
  fhir:RegulatedAuthorization.statusDate [ dateTime ]; # 0..1 The date at which the current status was assigned
  fhir:RegulatedAuthorization.validityPeriod [ Period ]; # 0..1 The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
  fhir:RegulatedAuthorization.indication [ CodeableReference(ClinicalUseDefinition) ], ... ; # 0..* Condition for which the use of the regulated product applies
  fhir:RegulatedAuthorization.intendedUse [ CodeableConcept ]; # 0..1 The intended use of the product, e.g. prevention, treatment
  fhir:RegulatedAuthorization.basis [ CodeableConcept ], ... ; # 0..* The legal/regulatory framework or reasons under which this authorization is granted
  fhir:RegulatedAuthorization.holder [ Reference(Organization) ]; # 0..1 The organization that has been granted this authorization, by the regulator
  fhir:RegulatedAuthorization.regulator [ Reference(Organization) ]; # 0..1 The regulatory authority or authorizing body granting the authorization
  fhir:RegulatedAuthorization.attachedDocument [ Reference(DocumentReference) ], ... ; # 0..* Additional information or supporting documentation about the authorization
  fhir:RegulatedAuthorization.case [ # 0..1 The case or regulatory procedure for granting or amending a regulated 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)
    fhir:RegulatedAuthorization.case.identifier [ Identifier ]; # 0..1 Identifier by which this case can be referenced
    fhir:RegulatedAuthorization.case.type [ CodeableConcept ]; # 0..1 The defining type of case
    fhir:RegulatedAuthorization.case.status [ CodeableConcept ]; # 0..1 The status associated with the case
    # RegulatedAuthorization.case.date[x] : 0..1 Relevant date for this case. One of these 2
      fhir:RegulatedAuthorization.case.datePeriod [ Period ]
      fhir:RegulatedAuthorization.case.dateDateTime [ dateTime ]
    fhir:RegulatedAuthorization.case.application [ See RegulatedAuthorization.case ], ... ; # 0..* Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
  ];
]

Changes since R4

This resource did not exist in Release 3

This analysis is available as XML or JSON.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization TUDomainResourceRegulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product

Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness identifier for the authorization, typically assigned by the authorizing body

... subject Σ0..*Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | ManufacturedItemDefinition | Ingredient | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location)The product type, treatment, facility or activity that is being authorized

... type Σ0..1CodeableConceptOverall type of this authorization, for example drug marketing approval, orphan drug designation
RegulatedAuthorizationType (Example)
... region Σ0..*CodeableConceptThe territory in which the authorization has been granted
Jurisdiction (Example)

... status Σ0..1CodeableConceptThe status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
PublicationStatus (Preferred)
... statusDate Σ0..1dateTimeThe date at which the current status was assigned
... validityPeriod Σ0..1PeriodThe time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
... indication Σ0..*CodeableReference(ClinicalUseDefinition)Condition for which the use of the regulated product applies

... intendedUse Σ0..1CodeableConceptThe intended use of the product, e.g. prevention, treatment
ProductIntendedUse (Preferred)
... basis Σ0..*CodeableConceptThe legal/regulatory framework or reasons under which this authorization is granted
RegulatedAuthorizationBasis (Example)

... holder Σ0..1Reference(Organization)The organization that has been granted this authorization, by the regulator
... regulator Σ0..1Reference(Organization)The regulatory authority or authorizing body granting the authorization
... attachedDocument Σ0..*Reference(DocumentReference)Additional information or supporting documentation about the authorization

... case Σ0..1BackboneElementThe case or regulatory procedure for granting or amending a regulated 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)
.... identifier Σ0..1IdentifierIdentifier by which this case can be referenced
.... type Σ0..1CodeableConceptThe defining type of case
RegulatedAuthorizationCaseType (Example)
.... status Σ0..1CodeableConceptThe status associated with the case
PublicationStatus (Preferred)
.... date[x] Σ0..1Relevant date for this case
..... datePeriodPeriod
..... dateDateTimedateTime
.... application Σ0..*see caseApplications submitted to obtain a regulated authorization. Steps within the longer running case or procedure


doco Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

RegulatedAuthorization (DomainResource)Business identifier for the authorization, typically assigned by the authorizing bodyidentifier : Identifier [0..*]The product type, treatment, facility or activity that is being authorizedsubject : Reference [0..*] « MedicinalProductDefinition| BiologicallyDerivedProduct|NutritionProduct| PackagedProductDefinition|ManufacturedItemDefinition| Ingredient|SubstanceDefinition|DeviceDefinition|ResearchStudy| ActivityDefinition|PlanDefinition|ObservationDefinition| Practitioner|Organization|Location »Overall type of this authorization, for example drug marketing approval, orphan drug designationtype : CodeableConcept [0..1] « null (Strength=Example)RegulatedAuthorizationType?? »General textual supporting informationdescription : markdown [0..1]The territory (e.g., country, jurisdiction etc.) in which the authorization has been grantedregion : CodeableConcept [0..*] « null (Strength=Example)Jurisdiction ValueSet?? »The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applicationsstatus : CodeableConcept [0..1] « null (Strength=Preferred)PublicationStatus? »The date at which the current status was assignedstatusDate : dateTime [0..1]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 datevalidityPeriod : Period [0..1]Condition for which the use of the regulated product appliesindication : CodeableReference [0..*] « ClinicalUseDefinition »The intended use of the product, e.g. prevention, treatment, diagnosisintendedUse : CodeableConcept [0..1] « null (Strength=Preferred)ProductIntendedUse? »The legal or regulatory framework against which this authorization is granted, or other reasons for itbasis : CodeableConcept [0..*] « null (Strength=Example)RegulatedAuthorizationBasis?? »The organization that has been granted this authorization, by some authoritative body (the 'regulator')holder : Reference [0..1] « Organization »The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etcregulator : Reference [0..1] « Organization »Additional information or supporting documentation about the authorizationattachedDocument : Reference [0..*] « DocumentReference »CaseIdentifier by which this case can be referencedidentifier : Identifier [0..1]The defining type of casetype : CodeableConcept [0..1] « null (Strength=Example)RegulatedAuthorizationCaseType?? »The status associated with the casestatus : CodeableConcept [0..1] « null (Strength=Preferred)PublicationStatus? »Relevant date for this casedate[x] : DataType [0..1] « Period|dateTime »A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization processapplication[0..*]The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)case[0..1]

XML Template

<RegulatedAuthorization xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Business identifier for the authorization, typically assigned by the authorizing body --></identifier>
 <subject><!-- 0..* Reference(ActivityDefinition|BiologicallyDerivedProduct|
   DeviceDefinition|Ingredient|Location|ManufacturedItemDefinition|
   MedicinalProductDefinition|NutritionProduct|ObservationDefinition|
   Organization|PackagedProductDefinition|PlanDefinition|Practitioner|
   ResearchStudy|SubstanceDefinition) The product type, treatment, facility or activity that is being authorized --></subject>
 <type><!-- 0..1 CodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation --></type>
 <description value="[markdown]"/><!-- 0..1 General textual supporting information -->
 <region><!-- 0..* CodeableConcept The territory in which the authorization has been granted --></region>
 <status><!-- 0..1 CodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications --></status>
 <statusDate value="[dateTime]"/><!-- 0..1 The date at which the current status was assigned -->
 <validityPeriod><!-- 0..1 Period The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date --></validityPeriod>
 <indication><!-- 0..* CodeableReference(ClinicalUseDefinition) Condition for which the use of the regulated product applies --></indication>
 <intendedUse><!-- 0..1 CodeableConcept The intended use of the product, e.g. prevention, treatment --></intendedUse>
 <basis><!-- 0..* CodeableConcept The legal/regulatory framework or reasons under which this authorization is granted --></basis>
 <holder><!-- 0..1 Reference(Organization) The organization that has been granted this authorization, by the regulator --></holder>
 <regulator><!-- 0..1 Reference(Organization) The regulatory authority or authorizing body granting the authorization --></regulator>
 <attachedDocument><!-- 0..* Reference(DocumentReference) Additional information or supporting documentation about the authorization --></attachedDocument>
 <case>  <!-- 0..1 The case or regulatory procedure for granting or amending a regulated 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) -->
  <identifier><!-- 0..1 Identifier Identifier by which this case can be referenced --></identifier>
  <type><!-- 0..1 CodeableConcept The defining type of case --></type>
  <status><!-- 0..1 CodeableConcept The status associated with the case --></status>
  <date[x]><!-- 0..1 Period|dateTime Relevant date for this case --></date[x]>
  <application><!-- 0..* Content as for RegulatedAuthorization.case Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure --></application>
 </case>
</RegulatedAuthorization>

JSON Template

{doco
  "resourceType" : "RegulatedAuthorization",
  // from Resource: id, meta, implicitRules, and language
  // from DomainResource: text, contained, extension, and modifierExtension
  "identifier" : [{ Identifier }], // Business identifier for the authorization, typically assigned by the authorizing body
  "subject" : [{ Reference(ActivityDefinition|BiologicallyDerivedProduct|
   DeviceDefinition|Ingredient|Location|ManufacturedItemDefinition|
   MedicinalProductDefinition|NutritionProduct|ObservationDefinition|
   Organization|PackagedProductDefinition|PlanDefinition|Practitioner|
   ResearchStudy|SubstanceDefinition) }], // The product type, treatment, facility or activity that is being authorized
  "type" : { CodeableConcept }, // Overall type of this authorization, for example drug marketing approval, orphan drug designation
  "description" : "<markdown>", // General textual supporting information
  "region" : [{ CodeableConcept }], // The territory in which the authorization has been granted
  "status" : { CodeableConcept }, // The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
  "statusDate" : "<dateTime>", // The date at which the current status was assigned
  "validityPeriod" : { Period }, // The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
  "indication" : [{ CodeableReference(ClinicalUseDefinition) }], // Condition for which the use of the regulated product applies
  "intendedUse" : { CodeableConcept }, // The intended use of the product, e.g. prevention, treatment
  "basis" : [{ CodeableConcept }], // The legal/regulatory framework or reasons under which this authorization is granted
  "holder" : { Reference(Organization) }, // The organization that has been granted this authorization, by the regulator
  "regulator" : { Reference(Organization) }, // The regulatory authority or authorizing body granting the authorization
  "attachedDocument" : [{ Reference(DocumentReference) }], // Additional information or supporting documentation about the authorization
  "case" : { // The case or regulatory procedure for granting or amending a regulated 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)
    "identifier" : { Identifier }, // Identifier by which this case can be referenced
    "type" : { CodeableConcept }, // The defining type of case
    "status" : { CodeableConcept }, // The status associated with the case
    // date[x]: Relevant date for this case. One of these 2:
    "datePeriod" : { Period },
    "dateDateTime" : "<dateTime>",
    "application" : [{ Content as for RegulatedAuthorization.case }] // Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
  }
}

Turtle Template

@prefix fhir: <http://hl7.org/fhir/> .doco


[ a fhir:RegulatedAuthorization;
  fhir:nodeRole fhir:treeRoot; # if this is the parser root

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:RegulatedAuthorization.identifier [ Identifier ], ... ; # 0..* Business identifier for the authorization, typically assigned by the authorizing body
  fhir:RegulatedAuthorization.subject [ Reference(ActivityDefinition|BiologicallyDerivedProduct|DeviceDefinition|Ingredient|
  Location|ManufacturedItemDefinition|MedicinalProductDefinition|
  NutritionProduct|ObservationDefinition|Organization|PackagedProductDefinition|
  PlanDefinition|Practitioner|ResearchStudy|SubstanceDefinition) ], ... ; # 0..* The product type, treatment, facility or activity that is being authorized
  fhir:RegulatedAuthorization.type [ CodeableConcept ]; # 0..1 Overall type of this authorization, for example drug marketing approval, orphan drug designation
  fhir:RegulatedAuthorization.description [ markdown ]; # 0..1 General textual supporting information
  fhir:RegulatedAuthorization.region [ CodeableConcept ], ... ; # 0..* The territory in which the authorization has been granted
  fhir:RegulatedAuthorization.status [ CodeableConcept ]; # 0..1 The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
  fhir:RegulatedAuthorization.statusDate [ dateTime ]; # 0..1 The date at which the current status was assigned
  fhir:RegulatedAuthorization.validityPeriod [ Period ]; # 0..1 The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
  fhir:RegulatedAuthorization.indication [ CodeableReference(ClinicalUseDefinition) ], ... ; # 0..* Condition for which the use of the regulated product applies
  fhir:RegulatedAuthorization.intendedUse [ CodeableConcept ]; # 0..1 The intended use of the product, e.g. prevention, treatment
  fhir:RegulatedAuthorization.basis [ CodeableConcept ], ... ; # 0..* The legal/regulatory framework or reasons under which this authorization is granted
  fhir:RegulatedAuthorization.holder [ Reference(Organization) ]; # 0..1 The organization that has been granted this authorization, by the regulator
  fhir:RegulatedAuthorization.regulator [ Reference(Organization) ]; # 0..1 The regulatory authority or authorizing body granting the authorization
  fhir:RegulatedAuthorization.attachedDocument [ Reference(DocumentReference) ], ... ; # 0..* Additional information or supporting documentation about the authorization
  fhir:RegulatedAuthorization.case [ # 0..1 The case or regulatory procedure for granting or amending a regulated 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)
    fhir:RegulatedAuthorization.case.identifier [ Identifier ]; # 0..1 Identifier by which this case can be referenced
    fhir:RegulatedAuthorization.case.type [ CodeableConcept ]; # 0..1 The defining type of case
    fhir:RegulatedAuthorization.case.status [ CodeableConcept ]; # 0..1 The status associated with the case
    # RegulatedAuthorization.case.date[x] : 0..1 Relevant date for this case. One of these 2
      fhir:RegulatedAuthorization.case.datePeriod [ Period ]
      fhir:RegulatedAuthorization.case.dateDateTime [ dateTime ]
    fhir:RegulatedAuthorization.case.application [ See RegulatedAuthorization.case ], ... ; # 0..* Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
  ];
]

Changes since Release 4

This resource did not exist in Release 3

This analysis is available as XML or JSON.

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

15.6.3.1 Terminology Bindings

PathDefinitionTypeReference
RegulatedAuthorization.type

Overall type of this authorization.

ExampleRegulatedAuthorizationType
RegulatedAuthorization.region

This value set defines a base set of codes for country, country subdivision and region for indicating where a resource is intended to be used.

Note: The codes for countries and country subdivisions are taken from ISO 3166 while the codes for "supra-national" regions are from UN Standard country or area codes for statistical use (M49) .

ExampleJurisdiction ValueSet
RegulatedAuthorization.status

The lifecycle status of an artifact.

PreferredPublicationStatus
RegulatedAuthorization.intendedUse

The overall intended use of a product.

PreferredProductIntendedUse
RegulatedAuthorization.basis

A legal or regulatory framework against which an authorization is granted, or other reasons for it.

ExampleRegulatedAuthorizationBasis
RegulatedAuthorization.case.type

The type of a case involved in an application.

ExampleRegulatedAuthorizationCaseType
RegulatedAuthorization.case.status

The lifecycle status of an artifact.

PreferredPublicationStatus

15.6.4 Search Parameters

Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

NameTypeDescriptionExpressionIn Common
casetokenThe case or procedure numberRegulatedAuthorization.case.identifier
case-typetokenThe defining type of caseRegulatedAuthorization.case.type
holderreferenceThe organization that holds the granted authorizationRegulatedAuthorization.holder
(Organization)
identifiertokenBusiness identifier for the authorization, typically assigned by the authorizing bodyRegulatedAuthorization.identifier
regiontokenThe territory (e.g., country, jurisdiction etc.) in which the authorization has been grantedRegulatedAuthorization.region
statustokenThe status that is authorised e.g. approved. Intermediate states can be tracked with cases and applicationsRegulatedAuthorization.status
subjectreferenceThe type of regulated product, treatment, facility or activity that is being authorizedRegulatedAuthorization.subject
(SubstanceDefinition, ManufacturedItemDefinition, Organization, BiologicallyDerivedProduct, PackagedProductDefinition, ResearchStudy, Practitioner, MedicinalProductDefinition, NutritionProduct, Ingredient, DeviceDefinition, ObservationDefinition, PlanDefinition, ActivityDefinition, Location)