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11.18 Resource RegulatedAuthorization - Content

Biomedical Research and Regulation Work GroupMaturity Level: 0 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

The regulatory authorization of a medicinal product.

This resource is still undergoing development and review by the appropriate Workgroups. At this time, is considered only as a draft resource not suitable for production implementation

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

This resource is referenced by PackagedProductDefinition, itself and RegulatedPackagedProduct.

This resource does not implement any patterns.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization ΣTUDomainResourceThe regulatory authorization of a medicinal product
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness identifier for the marketing authorization, as assigned by a regulator
... subject Σ0..1Reference(MedicinalProductDefinition | RegulatedPackagedProduct | DeviceDefinition)The product that is being authorized
... type Σ0..1CodeableConceptType of this authorization, for example drug marketing approval, orphan drug designation
... description Σ0..1stringGeneral textual supporting information
... region Σ0..*CodeableConceptThe region (country, jurisdiction etc.) in which the marketing authorization has been granted
... status Σ0..1CodeableConceptThe status of the marketing authorization
... statusDate Σ0..1dateTimeThe date at which the given status has become applicable
... validityPeriod Σ0..1PeriodThe 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 Σ0..*CodeableConceptThe legal framework against which this authorization is granted, or other reasons for it
... relatedDate Σ0..*BackboneElementOther dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on
.... date[x] Σ1..1Another date associated with the authorization
..... datePeriodPeriod
..... dateDateTimedateTime
.... type Σ1..1CodeableConceptType of this date, for example the data exclusitity period for a medicinal product
... jurisdictionalAuthorization Σ0..*Reference(RegulatedAuthorization)Authorization in areas within a country
... holder Σ0..1Reference(Organization)Marketing Authorization Holder
... regulator Σ0..1Reference(Organization)Medicines Regulatory Agency
... case Σ0..1BackboneElementThe case or regulatory procedure for granting or amending a marketing authorization
.... identifier Σ0..1IdentifierIdentifier for this case
.... type Σ0..1CodeableConceptType of case
.... status Σ0..1CodeableConceptThe status of the case
.... date[x] Σ0..1Date of case
..... datePeriodPeriod
..... dateDateTimedateTime
.... application Σ0..*see caseApplcations submitted to obtain a marketing authorization. Steps within the longer running case or procedure

doco Documentation for this format

UML Diagram (Legend)

RegulatedAuthorization (DomainResource)Business identifier for the marketing authorization, as assigned by a regulatoridentifier : Identifier [0..*]The product that is being authorizedsubject : Reference [0..1] « MedicinalProductDefinition| RegulatedPackagedProduct|DeviceDefinition »Type of this authorization, for example drug marketing approval, orphan drug designationtype : CodeableConcept [0..1]General textual supporting informationdescription : string [0..1]The region (country, jurisdiction etc.) in which the marketing authorization has been grantedregion : CodeableConcept [0..*]The status of the marketing authorizationstatus : CodeableConcept [0..1]The date at which the given status has become applicablestatusDate : dateTime [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 formatvalidityPeriod : Period [0..1]The legal framework against which this authorization is granted, or other reasons for itbasis : CodeableConcept [0..*]Authorization in areas within a countryjurisdictionalAuthorization : Reference [0..*] « RegulatedAuthorization »Marketing Authorization Holderholder : Reference [0..1] « Organization »Medicines Regulatory Agencyregulator : Reference [0..1] « Organization »RelatedDateAnother date associated with the authorizationdate[x] : Type [1..1] « Period|dateTime »Type of this date, for example the data exclusitity period for a medicinal producttype : CodeableConcept [1..1]CaseIdentifier for this caseidentifier : Identifier [0..1]Type of casetype : CodeableConcept [0..1]The status of the casestatus : CodeableConcept [0..1]Date of casedate[x] : Type [0..1] « Period|dateTime »Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so onrelatedDate[0..*]Applcations submitted to obtain a marketing authorization. Steps within the longer running case or procedureapplication[0..*]The case or regulatory procedure for granting or amending a marketing authorizationcase[0..1]

XML Template

<RegulatedAuthorization xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Business identifier for the marketing authorization, as assigned by a regulator --></identifier>
 <subject><!-- 0..1 Reference(DeviceDefinition|MedicinalProductDefinition|
   RegulatedPackagedProduct) 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="[string]"/><!-- 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

{doco
  "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(DeviceDefinition|MedicinalProductDefinition|
   RegulatedPackagedProduct) }, // The product that is being authorized
  "type" : { CodeableConcept }, // Type of this authorization, for example drug marketing approval, orphan drug designation
  "description" : "<string>", // 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/> .doco


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

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:RegulatedAuthorization.identifier [ Identifier ], ... ; # 0..* Business identifier for the marketing authorization, as assigned by a regulator
  fhir:RegulatedAuthorization.subject [ Reference(DeviceDefinition|MedicinalProductDefinition|RegulatedPackagedProduct) ]; # 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 [ string ]; # 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

NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization ΣTUDomainResourceThe regulatory authorization of a medicinal product
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness identifier for the marketing authorization, as assigned by a regulator
... subject Σ0..1Reference(MedicinalProductDefinition | RegulatedPackagedProduct | DeviceDefinition)The product that is being authorized
... type Σ0..1CodeableConceptType of this authorization, for example drug marketing approval, orphan drug designation
... description Σ0..1stringGeneral textual supporting information
... region Σ0..*CodeableConceptThe region (country, jurisdiction etc.) in which the marketing authorization has been granted
... status Σ0..1CodeableConceptThe status of the marketing authorization
... statusDate Σ0..1dateTimeThe date at which the given status has become applicable
... validityPeriod Σ0..1PeriodThe 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 Σ0..*CodeableConceptThe legal framework against which this authorization is granted, or other reasons for it
... relatedDate Σ0..*BackboneElementOther dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on
.... date[x] Σ1..1Another date associated with the authorization
..... datePeriodPeriod
..... dateDateTimedateTime
.... type Σ1..1CodeableConceptType of this date, for example the data exclusitity period for a medicinal product
... jurisdictionalAuthorization Σ0..*Reference(RegulatedAuthorization)Authorization in areas within a country
... holder Σ0..1Reference(Organization)Marketing Authorization Holder
... regulator Σ0..1Reference(Organization)Medicines Regulatory Agency
... case Σ0..1BackboneElementThe case or regulatory procedure for granting or amending a marketing authorization
.... identifier Σ0..1IdentifierIdentifier for this case
.... type Σ0..1CodeableConceptType of case
.... status Σ0..1CodeableConceptThe status of the case
.... date[x] Σ0..1Date of case
..... datePeriodPeriod
..... dateDateTimedateTime
.... application Σ0..*see caseApplcations submitted to obtain a marketing authorization. Steps within the longer running case or procedure

doco Documentation for this format

UML Diagram (Legend)

RegulatedAuthorization (DomainResource)Business identifier for the marketing authorization, as assigned by a regulatoridentifier : Identifier [0..*]The product that is being authorizedsubject : Reference [0..1] « MedicinalProductDefinition| RegulatedPackagedProduct|DeviceDefinition »Type of this authorization, for example drug marketing approval, orphan drug designationtype : CodeableConcept [0..1]General textual supporting informationdescription : string [0..1]The region (country, jurisdiction etc.) in which the marketing authorization has been grantedregion : CodeableConcept [0..*]The status of the marketing authorizationstatus : CodeableConcept [0..1]The date at which the given status has become applicablestatusDate : dateTime [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 formatvalidityPeriod : Period [0..1]The legal framework against which this authorization is granted, or other reasons for itbasis : CodeableConcept [0..*]Authorization in areas within a countryjurisdictionalAuthorization : Reference [0..*] « RegulatedAuthorization »Marketing Authorization Holderholder : Reference [0..1] « Organization »Medicines Regulatory Agencyregulator : Reference [0..1] « Organization »RelatedDateAnother date associated with the authorizationdate[x] : Type [1..1] « Period|dateTime »Type of this date, for example the data exclusitity period for a medicinal producttype : CodeableConcept [1..1]CaseIdentifier for this caseidentifier : Identifier [0..1]Type of casetype : CodeableConcept [0..1]The status of the casestatus : CodeableConcept [0..1]Date of casedate[x] : Type [0..1] « Period|dateTime »Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so onrelatedDate[0..*]Applcations submitted to obtain a marketing authorization. Steps within the longer running case or procedureapplication[0..*]The case or regulatory procedure for granting or amending a marketing authorizationcase[0..1]

XML Template

<RegulatedAuthorization xmlns="http://hl7.org/fhir"> doco
 <!-- from Resource: id, meta, implicitRules, and language -->
 <!-- from DomainResource: text, contained, extension, and modifierExtension -->
 <identifier><!-- 0..* Identifier Business identifier for the marketing authorization, as assigned by a regulator --></identifier>
 <subject><!-- 0..1 Reference(DeviceDefinition|MedicinalProductDefinition|
   RegulatedPackagedProduct) 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="[string]"/><!-- 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

{doco
  "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(DeviceDefinition|MedicinalProductDefinition|
   RegulatedPackagedProduct) }, // The product that is being authorized
  "type" : { CodeableConcept }, // Type of this authorization, for example drug marketing approval, orphan drug designation
  "description" : "<string>", // 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/> .doco


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

  # from Resource: .id, .meta, .implicitRules, and .language
  # from DomainResource: .text, .contained, .extension, and .modifierExtension
  fhir:RegulatedAuthorization.identifier [ Identifier ], ... ; # 0..* Business identifier for the marketing authorization, as assigned by a regulator
  fhir:RegulatedAuthorization.subject [ Reference(DeviceDefinition|MedicinalProductDefinition|RegulatedPackagedProduct) ]; # 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 [ string ]; # 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

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

NameTypeDescriptionExpressionIn Common
casetokenThe case or procedure numberRegulatedAuthorization.case.identifier
holderreferenceMarketing Authorization HolderRegulatedAuthorization.holder
(Organization)
identifiertokenBusiness identifier for the marketing authorization, as assigned by a regulatorRegulatedAuthorization.identifier
regiontokenThe region (country, jurisdiction etc.) in which the marketing authorization has been grantedRegulatedAuthorization.region
statustokenThe status of the marketing authorizationRegulatedAuthorization.status
subjectreferenceThe product that is being authorizedRegulatedAuthorization.subject
(MedicinalProductDefinition, RegulatedPackagedProduct, DeviceDefinition)