This page is part of the FHIR Specification (v4.2.0: R5 Preview #1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B

11.16 Resource RegulatedAuthorization - Content

Biomedical Research and Regulation

Work Group

Maturity Level: 0

Trial Use

Security Category: Anonymous

Compartments: Not linked to any defined compartments

The regulatory authorization of a medicinal product.

11.16.1 Scope and Usage

RegulatedAuthorization is a resource covering the Marketing Authorization of a Medicinal Product, from a regulatory point of view.

11.16.2 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	Σ TU		DomainResource	The regulatory authorization of a medicinal product Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Business identifier for the marketing authorization, as assigned by a regulator
subject	Σ	0..1	Reference(MedicinalProductDefinition \| PackagedProductDefinition \| DeviceDefinition \| ResearchStudy \| ActivityDefinition \| PlanDefinition \| ObservationDefinition)	The product that is being authorized
type	Σ	0..1	CodeableConcept	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 region (country, jurisdiction etc.) in which the marketing authorization has been granted
status	Σ	0..1	CodeableConcept	The status of the marketing authorization
statusDate	Σ	0..1	dateTime	The date at which the given status has become applicable
validityPeriod	Σ	0..1	Period	The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format
basis	Σ	0..*	CodeableConcept	The legal 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	Type of this date, for example the data exclusitity period for a medicinal product
jurisdictionalAuthorization	Σ	0..*	Reference(RegulatedAuthorization)	Authorization in areas within a country
holder	Σ	0..1	Reference(Organization)	Marketing Authorization Holder
regulator	Σ	0..1	Reference(Organization)	Medicines Regulatory Agency
case	Σ	0..1	BackboneElement	The case or regulatory procedure for granting or amending a marketing authorization
identifier	Σ	0..1	Identifier	Identifier for this case
type	Σ	0..1	CodeableConcept	Type of case
status	Σ	0..1	CodeableConcept	The status of the case
date[x]	Σ	0..1		Date of case
datePeriod			Period
dateDateTime			dateTime
application	Σ	0..*	see case	Applcations 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 marketing authorization, as assigned by a regulator --></identifier>
 <subject><!-- 0..1 Reference(ActivityDefinition|DeviceDefinition|
   MedicinalProductDefinition|ObservationDefinition|PackagedProductDefinition|
   PlanDefinition|ResearchStudy) The product that is being authorized --></subject>
 <type><!-- 0..1 CodeableConcept 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 region (country, jurisdiction etc.) in which the marketing authorization has been granted --></region>
 <status><!-- 0..1 CodeableConcept The status of the marketing authorization --></status>
 <statusDate value="[dateTime]"/><!-- 0..1 The date at which the given status has become applicable -->
 <validityPeriod><!-- 0..1 Period The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format --></validityPeriod>
 <basis><!-- 0..* CodeableConcept The legal 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 Type of this date, for example the data exclusitity period for a medicinal product --></type>
 </relatedDate>
 <jurisdictionalAuthorization><!-- 0..* Reference(RegulatedAuthorization) Authorization in areas within a country --></jurisdictionalAuthorization>
 <holder><!-- 0..1 Reference(Organization) Marketing Authorization Holder --></holder>
 <regulator><!-- 0..1 Reference(Organization) Medicines Regulatory Agency --></regulator>
 <case>  <!-- 0..1 The case or regulatory procedure for granting or amending a marketing authorization -->
  <identifier><!-- 0..1 Identifier Identifier for this case --></identifier>
  <type><!-- 0..1 CodeableConcept Type of case --></type>
  <status><!-- 0..1 CodeableConcept The status of the case --></status>
  <date[x]><!-- 0..1 Period|dateTime Date of case --></date[x]>
  <application><!-- 0..* Content as for RegulatedAuthorization.case Applcations 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 marketing authorization, as assigned by a regulator
  "subject" : { Reference(ActivityDefinition|DeviceDefinition|
   MedicinalProductDefinition|ObservationDefinition|PackagedProductDefinition|
   PlanDefinition|ResearchStudy) }, // The product that is being authorized
  "type" : { CodeableConcept }, // Type of this authorization, for example drug marketing approval, orphan drug designation
  "description" : "<markdown>", // General textual supporting information
  "region" : [{ CodeableConcept }], // The region (country, jurisdiction etc.) in which the marketing authorization has been granted
  "status" : { CodeableConcept }, // The status of the marketing authorization
  "statusDate" : "<dateTime>", // The date at which the given status has become applicable
  "validityPeriod" : { Period }, // The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format
  "basis" : [{ CodeableConcept }], // The legal 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!  Type of this date, for example the data exclusitity period for a medicinal product
  }],
  "jurisdictionalAuthorization" : [{ Reference(RegulatedAuthorization) }], // Authorization in areas within a country
  "holder" : { Reference(Organization) }, // Marketing Authorization Holder
  "regulator" : { Reference(Organization) }, // Medicines Regulatory Agency
  "case" : { // The case or regulatory procedure for granting or amending a marketing authorization
    "identifier" : { Identifier }, // Identifier for this case
    "type" : { CodeableConcept }, // Type of case
    "status" : { CodeableConcept }, // The status of the case
    // date[x]: Date of case. One of these 2:
    "datePeriod" : { Period },
    "dateDateTime" : "<dateTime>",
    "application" : [{ Content as for RegulatedAuthorization.case }] // Applcations 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 marketing authorization, as assigned by a regulator
  fhir:RegulatedAuthorization.subject [ Reference(ActivityDefinition|DeviceDefinition|MedicinalProductDefinition|
  ObservationDefinition|PackagedProductDefinition|PlanDefinition|ResearchStudy) ]; # 0..1 The product that is being authorized
  fhir:RegulatedAuthorization.type [ CodeableConcept ]; # 0..1 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 region (country, jurisdiction etc.) in which the marketing authorization has been granted
  fhir:RegulatedAuthorization.status [ CodeableConcept ]; # 0..1 The status of the marketing authorization
  fhir:RegulatedAuthorization.statusDate [ dateTime ]; # 0..1 The date at which the given status has become applicable
  fhir:RegulatedAuthorization.validityPeriod [ Period ]; # 0..1 The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format
  fhir:RegulatedAuthorization.basis [ CodeableConcept ], ... ; # 0..* The legal 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 Type of this date, for example the data exclusitity period for a medicinal product
  ], ...;
  fhir:RegulatedAuthorization.jurisdictionalAuthorization [ Reference(RegulatedAuthorization) ], ... ; # 0..* Authorization in areas within a country
  fhir:RegulatedAuthorization.holder [ Reference(Organization) ]; # 0..1 Marketing Authorization Holder
  fhir:RegulatedAuthorization.regulator [ Reference(Organization) ]; # 0..1 Medicines Regulatory Agency
  fhir:RegulatedAuthorization.case [ # 0..1 The case or regulatory procedure for granting or amending a marketing authorization
    fhir:RegulatedAuthorization.case.identifier [ Identifier ]; # 0..1 Identifier for this case
    fhir:RegulatedAuthorization.case.type [ CodeableConcept ]; # 0..1 Type of case
    fhir:RegulatedAuthorization.case.status [ CodeableConcept ]; # 0..1 The status of the case
    # RegulatedAuthorization.case.date[x] : 0..1 Date of case. One of these 2
      fhir:RegulatedAuthorization.case.datePeriod [ Period ]
      fhir:RegulatedAuthorization.case.dateDateTime [ dateTime ]
    fhir:RegulatedAuthorization.case.application [ See RegulatedAuthorization.case ], ... ; # 0..* Applcations 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	Σ TU		DomainResource	The regulatory authorization of a medicinal product Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
identifier	Σ	0..*	Identifier	Business identifier for the marketing authorization, as assigned by a regulator
subject	Σ	0..1	Reference(MedicinalProductDefinition \| PackagedProductDefinition \| DeviceDefinition \| ResearchStudy \| ActivityDefinition \| PlanDefinition \| ObservationDefinition)	The product that is being authorized
type	Σ	0..1	CodeableConcept	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 region (country, jurisdiction etc.) in which the marketing authorization has been granted
status	Σ	0..1	CodeableConcept	The status of the marketing authorization
statusDate	Σ	0..1	dateTime	The date at which the given status has become applicable
validityPeriod	Σ	0..1	Period	The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format
basis	Σ	0..*	CodeableConcept	The legal 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	Type of this date, for example the data exclusitity period for a medicinal product
jurisdictionalAuthorization	Σ	0..*	Reference(RegulatedAuthorization)	Authorization in areas within a country
holder	Σ	0..1	Reference(Organization)	Marketing Authorization Holder
regulator	Σ	0..1	Reference(Organization)	Medicines Regulatory Agency
case	Σ	0..1	BackboneElement	The case or regulatory procedure for granting or amending a marketing authorization
identifier	Σ	0..1	Identifier	Identifier for this case
type	Σ	0..1	CodeableConcept	Type of case
status	Σ	0..1	CodeableConcept	The status of the case
date[x]	Σ	0..1		Date of case
datePeriod			Period
dateDateTime			dateTime
application	Σ	0..*	see case	Applcations 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 marketing authorization, as assigned by a regulator --></identifier>
 <subject><!-- 0..1 Reference(ActivityDefinition|DeviceDefinition|
   MedicinalProductDefinition|ObservationDefinition|PackagedProductDefinition|
   PlanDefinition|ResearchStudy) The product that is being authorized --></subject>
 <type><!-- 0..1 CodeableConcept 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 region (country, jurisdiction etc.) in which the marketing authorization has been granted --></region>
 <status><!-- 0..1 CodeableConcept The status of the marketing authorization --></status>
 <statusDate value="[dateTime]"/><!-- 0..1 The date at which the given status has become applicable -->
 <validityPeriod><!-- 0..1 Period The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format --></validityPeriod>
 <basis><!-- 0..* CodeableConcept The legal 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 Type of this date, for example the data exclusitity period for a medicinal product --></type>
 </relatedDate>
 <jurisdictionalAuthorization><!-- 0..* Reference(RegulatedAuthorization) Authorization in areas within a country --></jurisdictionalAuthorization>
 <holder><!-- 0..1 Reference(Organization) Marketing Authorization Holder --></holder>
 <regulator><!-- 0..1 Reference(Organization) Medicines Regulatory Agency --></regulator>
 <case>  <!-- 0..1 The case or regulatory procedure for granting or amending a marketing authorization -->
  <identifier><!-- 0..1 Identifier Identifier for this case --></identifier>
  <type><!-- 0..1 CodeableConcept Type of case --></type>
  <status><!-- 0..1 CodeableConcept The status of the case --></status>
  <date[x]><!-- 0..1 Period|dateTime Date of case --></date[x]>
  <application><!-- 0..* Content as for RegulatedAuthorization.case Applcations 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 marketing authorization, as assigned by a regulator
  "subject" : { Reference(ActivityDefinition|DeviceDefinition|
   MedicinalProductDefinition|ObservationDefinition|PackagedProductDefinition|
   PlanDefinition|ResearchStudy) }, // The product that is being authorized
  "type" : { CodeableConcept }, // Type of this authorization, for example drug marketing approval, orphan drug designation
  "description" : "<markdown>", // General textual supporting information
  "region" : [{ CodeableConcept }], // The region (country, jurisdiction etc.) in which the marketing authorization has been granted
  "status" : { CodeableConcept }, // The status of the marketing authorization
  "statusDate" : "<dateTime>", // The date at which the given status has become applicable
  "validityPeriod" : { Period }, // The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format
  "basis" : [{ CodeableConcept }], // The legal 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!  Type of this date, for example the data exclusitity period for a medicinal product
  }],
  "jurisdictionalAuthorization" : [{ Reference(RegulatedAuthorization) }], // Authorization in areas within a country
  "holder" : { Reference(Organization) }, // Marketing Authorization Holder
  "regulator" : { Reference(Organization) }, // Medicines Regulatory Agency
  "case" : { // The case or regulatory procedure for granting or amending a marketing authorization
    "identifier" : { Identifier }, // Identifier for this case
    "type" : { CodeableConcept }, // Type of case
    "status" : { CodeableConcept }, // The status of the case
    // date[x]: Date of case. One of these 2:
    "datePeriod" : { Period },
    "dateDateTime" : "<dateTime>",
    "application" : [{ Content as for RegulatedAuthorization.case }] // Applcations 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 marketing authorization, as assigned by a regulator
  fhir:RegulatedAuthorization.subject [ Reference(ActivityDefinition|DeviceDefinition|MedicinalProductDefinition|
  ObservationDefinition|PackagedProductDefinition|PlanDefinition|ResearchStudy) ]; # 0..1 The product that is being authorized
  fhir:RegulatedAuthorization.type [ CodeableConcept ]; # 0..1 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 region (country, jurisdiction etc.) in which the marketing authorization has been granted
  fhir:RegulatedAuthorization.status [ CodeableConcept ]; # 0..1 The status of the marketing authorization
  fhir:RegulatedAuthorization.statusDate [ dateTime ]; # 0..1 The date at which the given status has become applicable
  fhir:RegulatedAuthorization.validityPeriod [ Period ]; # 0..1 The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format
  fhir:RegulatedAuthorization.basis [ CodeableConcept ], ... ; # 0..* The legal 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 Type of this date, for example the data exclusitity period for a medicinal product
  ], ...;
  fhir:RegulatedAuthorization.jurisdictionalAuthorization [ Reference(RegulatedAuthorization) ], ... ; # 0..* Authorization in areas within a country
  fhir:RegulatedAuthorization.holder [ Reference(Organization) ]; # 0..1 Marketing Authorization Holder
  fhir:RegulatedAuthorization.regulator [ Reference(Organization) ]; # 0..1 Medicines Regulatory Agency
  fhir:RegulatedAuthorization.case [ # 0..1 The case or regulatory procedure for granting or amending a marketing authorization
    fhir:RegulatedAuthorization.case.identifier [ Identifier ]; # 0..1 Identifier for this case
    fhir:RegulatedAuthorization.case.type [ CodeableConcept ]; # 0..1 Type of case
    fhir:RegulatedAuthorization.case.status [ CodeableConcept ]; # 0..1 The status of the case
    # RegulatedAuthorization.case.date[x] : 0..1 Date of case. One of these 2
      fhir:RegulatedAuthorization.case.datePeriod [ Period ]
      fhir:RegulatedAuthorization.case.dateDateTime [ dateTime ]
    fhir:RegulatedAuthorization.case.application [ See RegulatedAuthorization.case ], ... ; # 0..* Applcations 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

11.16.4 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	Type of case	RegulatedAuthorization.case.type
holder	reference	Marketing Authorization Holder	RegulatedAuthorization.holder (Organization)
identifier	token	Business identifier for the marketing authorization, as assigned by a regulator	RegulatedAuthorization.identifier
region	token	The region (country, jurisdiction etc.) in which the marketing authorization has been granted	RegulatedAuthorization.region
status	token	The status of the marketing authorization	RegulatedAuthorization.status
subject	reference	The product that is being authorized	RegulatedAuthorization.subject (MedicinalProductDefinition, DeviceDefinition, ObservationDefinition, PlanDefinition, PackagedProductDefinition, ResearchStudy, ActivityDefinition)