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15.6 Resource RegulatedAuthorization - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 1

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

This resource is referenced by MedicinalProductDefinition, PackagedProductDefinition and itself.

This resource does not implement any patterns.

Structure

Name	Flags	Card.	Type	Description & Constraints
RegulatedAuthorization	TU		DomainResource	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 Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Business identifier for the authorization, typically this is assigned by the authorizing body
subject	Σ	0..1	Reference(MedicinalProductDefinition \| BiologicallyDerivedProduct \| NutritionProduct \| PackagedProductDefinition \| SubstanceDefinition \| DeviceDefinition \| ResearchStudy \| ActivityDefinition \| PlanDefinition \| ObservationDefinition \| Practitioner \| Organization \| Location)	The type of regulated product, 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
description	Σ	0..1	markdown	General textual supporting information
region	Σ	0..*	CodeableConcept	The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted
status	Σ	0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
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, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date
indication	Σ	0..1	CodeableReference(ClinicalUseIssue)	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
basis	Σ	0..*	CodeableConcept	The legal or regulatory framework against which this authorization is granted, or other reasons for it
relatedDate	Σ	0..*	BackboneElement	Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on
date[x]	Σ	1..1		Another date associated with the authorization
datePeriod			Period
dateDateTime			dateTime
type	Σ	1..1	CodeableConcept	The meaning of the related date for a regulated product, treatment, facility or activity. As an example, the data exclusivity period for a regulated product
jurisdictionalAuthorization	Σ	0..*	Reference(RegulatedAuthorization)	Authorization in areas within a country
holder	Σ	0..1	Reference(Organization)	The organization that holds the granted authorization
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 marketing authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
identifier	Σ	0..1	Identifier	Identifier by which this case can be referenced
type	Σ	0..1	CodeableConcept	The defining type of case
status	Σ	0..1	CodeableConcept	The status associated with the case
date[x]	Σ	0..1		Relevant date for this of case
datePeriod			Period
dateDateTime			dateTime
application	Σ	0..*	see case	Applications submitted to obtain a marketing authorization. Steps within the longer running case or procedure
Documentation for this format

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 this is assigned by the authorizing body --></identifier>
 <subject><!-- 0..1 Reference(ActivityDefinition|BiologicallyDerivedProduct|
   DeviceDefinition|Location|MedicinalProductDefinition|NutritionProduct|
   ObservationDefinition|Organization|PackagedProductDefinition|PlanDefinition|
   Practitioner|ResearchStudy|SubstanceDefinition) The type of regulated product, 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 (e.g., country, jurisdiction etc.) 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, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date --></validityPeriod>
 <indication><!-- 0..1 CodeableReference(ClinicalUseIssue) 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 or regulatory framework against which this authorization is granted, or other reasons for it --></basis>
 <relatedDate>  <!-- 0..* Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on -->
  <date[x]><!-- 1..1 Period|dateTime Another date associated with the authorization --></date[x]>
  <type><!-- 1..1 CodeableConcept The meaning of the related date for a regulated product, treatment, facility or activity.  As an example, the data exclusivity period for a regulated product --></type>
 </relatedDate>
 <jurisdictionalAuthorization><!-- 0..* Reference(RegulatedAuthorization) Authorization in areas within a country --></jurisdictionalAuthorization>
 <holder><!-- 0..1 Reference(Organization) The organization that holds the granted authorization --></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 marketing authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) -->
  <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 of case --></date[x]>
  <application><!-- 0..* Content as for RegulatedAuthorization.case Applications submitted to obtain a marketing 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 this is assigned by the authorizing body
  "subject" : { Reference(ActivityDefinition|BiologicallyDerivedProduct|
   DeviceDefinition|Location|MedicinalProductDefinition|NutritionProduct|
   ObservationDefinition|Organization|PackagedProductDefinition|PlanDefinition|
   Practitioner|ResearchStudy|SubstanceDefinition) }, // The type of regulated product, 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 (e.g., country, jurisdiction etc.) 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, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date
  "indication" : { CodeableReference(ClinicalUseIssue) }, // 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 or regulatory framework against which this authorization is granted, or other reasons for it
  "relatedDate" : [{ // Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on
    // date[x]: Another date associated with the authorization. One of these 2:
    "datePeriod" : { Period },
    "dateDateTime" : "<dateTime>",
    "type" : { CodeableConcept } // R!  The meaning of the related date for a regulated product, treatment, facility or activity.  As an example, the data exclusivity period for a regulated product
  }],
  "jurisdictionalAuthorization" : [{ Reference(RegulatedAuthorization) }], // Authorization in areas within a country
  "holder" : { Reference(Organization) }, // The organization that holds the granted authorization
  "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 marketing authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
    "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 of case. One of these 2:
    "datePeriod" : { Period },
    "dateDateTime" : "<dateTime>",
    "application" : [{ Content as for RegulatedAuthorization.case }] // Applications submitted to obtain a marketing 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 this is assigned by the authorizing body
  fhir:RegulatedAuthorization.subject [ Reference(ActivityDefinition|BiologicallyDerivedProduct|DeviceDefinition|Location|
  MedicinalProductDefinition|NutritionProduct|ObservationDefinition|Organization|
  PackagedProductDefinition|PlanDefinition|Practitioner|ResearchStudy|
  SubstanceDefinition) ]; # 0..1 The type of regulated product, 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 (e.g., country, jurisdiction etc.) 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, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date
  fhir:RegulatedAuthorization.indication [ CodeableReference(ClinicalUseIssue) ]; # 0..1 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 or regulatory framework against which this authorization is granted, or other reasons for it
  fhir:RegulatedAuthorization.relatedDate [ # 0..* Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on
    # RegulatedAuthorization.relatedDate.date[x] : 1..1 Another date associated with the authorization. One of these 2
      fhir:RegulatedAuthorization.relatedDate.datePeriod [ Period ]
      fhir:RegulatedAuthorization.relatedDate.dateDateTime [ dateTime ]
    fhir:RegulatedAuthorization.relatedDate.type [ CodeableConcept ]; # 1..1 The meaning of the related date for a regulated product, treatment, facility or activity.  As an example, the data exclusivity period for a regulated product
  ], ...;
  fhir:RegulatedAuthorization.jurisdictionalAuthorization [ Reference(RegulatedAuthorization) ], ... ; # 0..* Authorization in areas within a country
  fhir:RegulatedAuthorization.holder [ Reference(Organization) ]; # 0..1 The organization that holds the granted authorization
  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 marketing authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
    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 of 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 marketing authorization. Steps within the longer running case or procedure
  ];
]

Changes since R3

This resource did not exist in Release 2

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 that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to 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 this is assigned by the authorizing body
subject	Σ	0..1	Reference(MedicinalProductDefinition \| BiologicallyDerivedProduct \| NutritionProduct \| PackagedProductDefinition \| SubstanceDefinition \| DeviceDefinition \| ResearchStudy \| ActivityDefinition \| PlanDefinition \| ObservationDefinition \| Practitioner \| Organization \| Location)	The type of regulated product, 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
description	Σ	0..1	markdown	General textual supporting information
region	Σ	0..*	CodeableConcept	The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted
status	Σ	0..1	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
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, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date
indication	Σ	0..1	CodeableReference(ClinicalUseIssue)	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
basis	Σ	0..*	CodeableConcept	The legal or regulatory framework against which this authorization is granted, or other reasons for it
relatedDate	Σ	0..*	BackboneElement	Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on
date[x]	Σ	1..1		Another date associated with the authorization
datePeriod			Period
dateDateTime			dateTime
type	Σ	1..1	CodeableConcept	The meaning of the related date for a regulated product, treatment, facility or activity. As an example, the data exclusivity period for a regulated product
jurisdictionalAuthorization	Σ	0..*	Reference(RegulatedAuthorization)	Authorization in areas within a country
holder	Σ	0..1	Reference(Organization)	The organization that holds the granted authorization
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 marketing authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
identifier	Σ	0..1	Identifier	Identifier by which this case can be referenced
type	Σ	0..1	CodeableConcept	The defining type of case
status	Σ	0..1	CodeableConcept	The status associated with the case
date[x]	Σ	0..1		Relevant date for this of case
datePeriod			Period
dateDateTime			dateTime
application	Σ	0..*	see case	Applications submitted to obtain a marketing authorization. Steps within the longer running case or procedure
Documentation for this format

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 this is assigned by the authorizing body --></identifier>
 <subject><!-- 0..1 Reference(ActivityDefinition|BiologicallyDerivedProduct|
   DeviceDefinition|Location|MedicinalProductDefinition|NutritionProduct|
   ObservationDefinition|Organization|PackagedProductDefinition|PlanDefinition|
   Practitioner|ResearchStudy|SubstanceDefinition) The type of regulated product, 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 (e.g., country, jurisdiction etc.) 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, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date --></validityPeriod>
 <indication><!-- 0..1 CodeableReference(ClinicalUseIssue) 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 or regulatory framework against which this authorization is granted, or other reasons for it --></basis>
 <relatedDate>  <!-- 0..* Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on -->
  <date[x]><!-- 1..1 Period|dateTime Another date associated with the authorization --></date[x]>
  <type><!-- 1..1 CodeableConcept The meaning of the related date for a regulated product, treatment, facility or activity.  As an example, the data exclusivity period for a regulated product --></type>
 </relatedDate>
 <jurisdictionalAuthorization><!-- 0..* Reference(RegulatedAuthorization) Authorization in areas within a country --></jurisdictionalAuthorization>
 <holder><!-- 0..1 Reference(Organization) The organization that holds the granted authorization --></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 marketing authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) -->
  <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 of case --></date[x]>
  <application><!-- 0..* Content as for RegulatedAuthorization.case Applications submitted to obtain a marketing 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 this is assigned by the authorizing body
  "subject" : { Reference(ActivityDefinition|BiologicallyDerivedProduct|
   DeviceDefinition|Location|MedicinalProductDefinition|NutritionProduct|
   ObservationDefinition|Organization|PackagedProductDefinition|PlanDefinition|
   Practitioner|ResearchStudy|SubstanceDefinition) }, // The type of regulated product, 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 (e.g., country, jurisdiction etc.) 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, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date
  "indication" : { CodeableReference(ClinicalUseIssue) }, // 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 or regulatory framework against which this authorization is granted, or other reasons for it
  "relatedDate" : [{ // Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on
    // date[x]: Another date associated with the authorization. One of these 2:
    "datePeriod" : { Period },
    "dateDateTime" : "<dateTime>",
    "type" : { CodeableConcept } // R!  The meaning of the related date for a regulated product, treatment, facility or activity.  As an example, the data exclusivity period for a regulated product
  }],
  "jurisdictionalAuthorization" : [{ Reference(RegulatedAuthorization) }], // Authorization in areas within a country
  "holder" : { Reference(Organization) }, // The organization that holds the granted authorization
  "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 marketing authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
    "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 of case. One of these 2:
    "datePeriod" : { Period },
    "dateDateTime" : "<dateTime>",
    "application" : [{ Content as for RegulatedAuthorization.case }] // Applications submitted to obtain a marketing 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 this is assigned by the authorizing body
  fhir:RegulatedAuthorization.subject [ Reference(ActivityDefinition|BiologicallyDerivedProduct|DeviceDefinition|Location|
  MedicinalProductDefinition|NutritionProduct|ObservationDefinition|Organization|
  PackagedProductDefinition|PlanDefinition|Practitioner|ResearchStudy|
  SubstanceDefinition) ]; # 0..1 The type of regulated product, 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 (e.g., country, jurisdiction etc.) 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, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date
  fhir:RegulatedAuthorization.indication [ CodeableReference(ClinicalUseIssue) ]; # 0..1 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 or regulatory framework against which this authorization is granted, or other reasons for it
  fhir:RegulatedAuthorization.relatedDate [ # 0..* Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on
    # RegulatedAuthorization.relatedDate.date[x] : 1..1 Another date associated with the authorization. One of these 2
      fhir:RegulatedAuthorization.relatedDate.datePeriod [ Period ]
      fhir:RegulatedAuthorization.relatedDate.dateDateTime [ dateTime ]
    fhir:RegulatedAuthorization.relatedDate.type [ CodeableConcept ]; # 1..1 The meaning of the related date for a regulated product, treatment, facility or activity.  As an example, the data exclusivity period for a regulated product
  ], ...;
  fhir:RegulatedAuthorization.jurisdictionalAuthorization [ Reference(RegulatedAuthorization) ], ... ; # 0..* Authorization in areas within a country
  fhir:RegulatedAuthorization.holder [ Reference(Organization) ]; # 0..1 The organization that holds the granted authorization
  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 marketing authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
    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 of 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 marketing authorization. Steps within the longer running case or procedure
  ];
]

Changes since Release 3

This resource did not exist in Release 2

This analysis is available as XML or JSON.

See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis a

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, Organization, BiologicallyDerivedProduct, PackagedProductDefinition, ResearchStudy, Practitioner, MedicinalProductDefinition, NutritionProduct, DeviceDefinition, ObservationDefinition, PlanDefinition, ActivityDefinition, Location)