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15.6 Resource RegulatedAuthorization - Content

Biomedical Research and Regulation icon

Work Group

Maturity Level: 2

Trial Use

Security 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.

Structure

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization	TU		DomainResource	Regulatory 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	Σ	0..*	Identifier	Business identifier for the authorization, typically assigned by the authorizing body
subject	Σ	0..*	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	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation RegulatedAuthorizationType (Example)
description	Σ	0..1	markdown	General textual supporting information
region	Σ	0..*	CodeableConcept	The territory in which the authorization has been granted Jurisdiction (Example)
status	Σ	0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications PublicationStatus (Preferred)
statusDate	Σ	0..1	dateTime	The date at which the current status was assigned
validityPeriod	Σ	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
indication	Σ	0..*	CodeableReference(ClinicalUseDefinition)	Condition for which the use of the regulated product applies
intendedUse	Σ	0..1	CodeableConcept	The intended use of the product, e.g. prevention, treatment ProductIntendedUse (Preferred)
basis	Σ	0..*	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is granted RegulatedAuthorizationBasis (Example)
holder	Σ	0..1	Reference(Organization)	The organization that has been granted this authorization, by the regulator
regulator	Σ	0..1	Reference(Organization)	The regulatory authority or authorizing body granting the authorization
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the authorization
case	Σ	0..1	BackboneElement	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	Σ	0..1	Identifier	Identifier by which this case can be referenced
type	Σ	0..1	CodeableConcept	The defining type of case RegulatedAuthorizationCaseType (Example)
status	Σ	0..1	CodeableConcept	The status associated with the case PublicationStatus (Preferred)
date[x]	Σ	0..1		Relevant date for this case
datePeriod			Period
dateDateTime			dateTime
application	Σ	0..*	see case	Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

XML Template

<RegulatedAuthorization xmlns="http://hl7.org/fhir"> 
 <!-- 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

{
  "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/> .


[ 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

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization	TU		DomainResource	Regulatory 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	Σ	0..*	Identifier	Business identifier for the authorization, typically assigned by the authorizing body
subject	Σ	0..*	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	Σ	0..1	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designation RegulatedAuthorizationType (Example)
description	Σ	0..1	markdown	General textual supporting information
region	Σ	0..*	CodeableConcept	The territory in which the authorization has been granted Jurisdiction (Example)
status	Σ	0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications PublicationStatus (Preferred)
statusDate	Σ	0..1	dateTime	The date at which the current status was assigned
validityPeriod	Σ	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
indication	Σ	0..*	CodeableReference(ClinicalUseDefinition)	Condition for which the use of the regulated product applies
intendedUse	Σ	0..1	CodeableConcept	The intended use of the product, e.g. prevention, treatment ProductIntendedUse (Preferred)
basis	Σ	0..*	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is granted RegulatedAuthorizationBasis (Example)
holder	Σ	0..1	Reference(Organization)	The organization that has been granted this authorization, by the regulator
regulator	Σ	0..1	Reference(Organization)	The regulatory authority or authorizing body granting the authorization
attachedDocument	Σ	0..*	Reference(DocumentReference)	Additional information or supporting documentation about the authorization
case	Σ	0..1	BackboneElement	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	Σ	0..1	Identifier	Identifier by which this case can be referenced
type	Σ	0..1	CodeableConcept	The defining type of case RegulatedAuthorizationCaseType (Example)
status	Σ	0..1	CodeableConcept	The status associated with the case PublicationStatus (Preferred)
date[x]	Σ	0..1		Relevant date for this case
datePeriod			Period
dateDateTime			dateTime
application	Σ	0..*	see case	Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
Documentation for this format

See the Extensions for this resource

UML Diagram (Legend)

XML Template

<RegulatedAuthorization xmlns="http://hl7.org/fhir"> 
 <!-- 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

{
  "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/> .


[ 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

Path	Definition	Type	Reference
RegulatedAuthorization.type	Overall type of this authorization.	Example	RegulatedAuthorizationType
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) .	Example	Jurisdiction ValueSet
RegulatedAuthorization.status	The lifecycle status of an artifact.	Preferred	PublicationStatus
RegulatedAuthorization.intendedUse	The overall intended use of a product.	Preferred	ProductIntendedUse
RegulatedAuthorization.basis	A legal or regulatory framework against which an authorization is granted, or other reasons for it.	Example	RegulatedAuthorizationBasis
RegulatedAuthorization.case.type	The type of a case involved in an application.	Example	RegulatedAuthorizationCaseType
RegulatedAuthorization.case.status	The lifecycle status of an artifact.	Preferred	PublicationStatus

Path

Definition

Type

Reference

RegulatedAuthorization.type

Overall type of this authorization.

Example

RegulatedAuthorizationType

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 icon while the codes for "supra-national" regions are from UN Standard country or area codes for statistical use (M49) icon .

Example

Jurisdiction ValueSet

RegulatedAuthorization.status

The lifecycle status of an artifact.

Preferred

PublicationStatus

RegulatedAuthorization.intendedUse

The overall intended use of a product.

Preferred

ProductIntendedUse

RegulatedAuthorization.basis

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

Example

RegulatedAuthorizationBasis

RegulatedAuthorization.case.type

The type of a case involved in an application.

Example

RegulatedAuthorizationCaseType

RegulatedAuthorization.case.status

The lifecycle status of an artifact.

Preferred

PublicationStatus

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.

Name	Type	Description	Expression	In Common
case	token	The case or procedure number	RegulatedAuthorization.case.identifier
case-type	token	The defining type of case	RegulatedAuthorization.case.type
holder	reference	The organization that holds the granted authorization	RegulatedAuthorization.holder (Organization)
identifier	token	Business identifier for the authorization, typically assigned by the authorizing body	RegulatedAuthorization.identifier
region	token	The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted	RegulatedAuthorization.region
status	token	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications	RegulatedAuthorization.status
subject	reference	The type of regulated product, treatment, facility or activity that is being authorized	RegulatedAuthorization.subject (SubstanceDefinition, ManufacturedItemDefinition, Organization, BiologicallyDerivedProduct, PackagedProductDefinition, ResearchStudy, Practitioner, MedicinalProductDefinition, NutritionProduct, Ingredient, DeviceDefinition, ObservationDefinition, PlanDefinition, ActivityDefinition, Location)