15.6 Resource RegulatedAuthorization - Content

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 Binding: RegulatedAuthorizationType Regulated Authorization Type ( Example )
description	Σ	0..1	markdown	General textual supporting information
region	Σ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: Jurisdiction ValueSet ( Example )
status	Σ	0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: 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..1 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 Binding: ProductIntendedUse Product Intended Use ( Preferred )
basis	Σ	0..*	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is granted Binding: RegulatedAuthorizationBasis Regulated Authorization Basis ( 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
case attachedDocument	Σ	0..1 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 Binding: RegulatedAuthorizationCaseType Regulated Authorization Case Type ( Example )
status	Σ	0..1	CodeableConcept	The status associated with the case Binding: 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

<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|
   |
   |
   </subject>

   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>

 <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>

{
  "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
  }
}

@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:
  fhir:|
  |
  |
  
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
    fhir:
    fhir:
    fhir:
    # . One of these 2
      fhir: ]
      fhir: ]
    fhir:
  ];

  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Business identifier for the authorization, typically assigned by the authorizing body
  fhir: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:type [ CodeableConcept ] ; # 0..1 Overall type of this authorization, for example drug marketing approval, orphan drug designation
  fhir:description [ markdown ] ; # 0..1 General textual supporting information
  fhir:region  ( [ CodeableConcept ] ... ) ; # 0..* The territory in which the authorization has been granted
  fhir:status [ CodeableConcept ] ; # 0..1 The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
  fhir:statusDate [ dateTime ] ; # 0..1 The date at which the current status was assigned
  fhir: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:indication  ( [ CodeableReference(ClinicalUseDefinition) ] ... ) ; # 0..* Condition for which the use of the regulated product applies
  fhir:intendedUse [ CodeableConcept ] ; # 0..1 The intended use of the product, e.g. prevention, treatment
  fhir:basis  ( [ CodeableConcept ] ... ) ; # 0..* The legal/regulatory framework or reasons under which this authorization is granted
  fhir:holder [ Reference(Organization) ] ; # 0..1 The organization that has been granted this authorization, by the regulator
  fhir:regulator [ Reference(Organization) ] ; # 0..1 The regulatory authority or authorizing body granting the authorization
  fhir:attachedDocument  ( [ Reference(DocumentReference) ] ... ) ; # 0..* Additional information or supporting documentation about the authorization
  fhir: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:identifier [ Identifier ] ; # 0..1 Identifier by which this case can be referenced
    fhir:type [ CodeableConcept ] ; # 0..1 The defining type of case
    fhir:status [ CodeableConcept ] ; # 0..1 The status associated with the case
    # date[x] : 0..1 Relevant date for this case. One of these 2
      fhir:date [  a fhir:Period ; Period ]
      fhir:date [  a fhir:dateTime ; dateTime ]
    fhir:application  ( [ See RegulatedAuthorization.case ] ... ) ; # 0..* Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
  ] ;

]

This resource did not exist in Release 3

This analysis is available as XML or JSON .

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 Binding: RegulatedAuthorizationType Regulated Authorization Type ( Example )
description	Σ	0..1	markdown	General textual supporting information
region	Σ	0..*	CodeableConcept	The territory in which the authorization has been granted Binding: Jurisdiction ValueSet ( Example )
status	Σ	0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: 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..1 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 Binding: ProductIntendedUse Product Intended Use ( Preferred )
basis	Σ	0..*	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is granted Binding: RegulatedAuthorizationBasis Regulated Authorization Basis ( 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
case attachedDocument	Σ	0..1 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 Binding: RegulatedAuthorizationCaseType Regulated Authorization Case Type ( Example )
status	Σ	0..1	CodeableConcept	The status associated with the case Binding: 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

<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|
   |
   |
   </subject>

   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>

 <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>

{
  "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
  }
}

@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:
  fhir:|
  |
  |
  
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
  fhir:
    fhir:
    fhir:
    fhir:
    # . One of these 2
      fhir: ]
      fhir: ]
    fhir:
  ];

  fhir:identifier  ( [ Identifier ] ... ) ; # 0..* Business identifier for the authorization, typically assigned by the authorizing body
  fhir: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:type [ CodeableConcept ] ; # 0..1 Overall type of this authorization, for example drug marketing approval, orphan drug designation
  fhir:description [ markdown ] ; # 0..1 General textual supporting information
  fhir:region  ( [ CodeableConcept ] ... ) ; # 0..* The territory in which the authorization has been granted
  fhir:status [ CodeableConcept ] ; # 0..1 The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
  fhir:statusDate [ dateTime ] ; # 0..1 The date at which the current status was assigned
  fhir: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:indication  ( [ CodeableReference(ClinicalUseDefinition) ] ... ) ; # 0..* Condition for which the use of the regulated product applies
  fhir:intendedUse [ CodeableConcept ] ; # 0..1 The intended use of the product, e.g. prevention, treatment
  fhir:basis  ( [ CodeableConcept ] ... ) ; # 0..* The legal/regulatory framework or reasons under which this authorization is granted
  fhir:holder [ Reference(Organization) ] ; # 0..1 The organization that has been granted this authorization, by the regulator
  fhir:regulator [ Reference(Organization) ] ; # 0..1 The regulatory authority or authorizing body granting the authorization
  fhir:attachedDocument  ( [ Reference(DocumentReference) ] ... ) ; # 0..* Additional information or supporting documentation about the authorization
  fhir: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:identifier [ Identifier ] ; # 0..1 Identifier by which this case can be referenced
    fhir:type [ CodeableConcept ] ; # 0..1 The defining type of case
    fhir:status [ CodeableConcept ] ; # 0..1 The status associated with the case
    # date[x] : 0..1 Relevant date for this case. One of these 2
      fhir:date [  a fhir:Period ; Period ]
      fhir:date [  a fhir:dateTime ; dateTime ]
    fhir:application  ( [ See RegulatedAuthorization.case ] ... ) ; # 0..* Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
  ] ;

]

This resource did not exist in Release 3

This analysis is available as XML or JSON .