Release 4

11.16 Resource RegulatedAuthorization - Content

Biomedical Research and Regulation Work GroupMaturity Level: 1 Trial UseSecurity Category: Anonymous Compartments: Not linked to any defined compartments

The regulatory authorization of a medicinal product, device or process.

RegulatedAuthorization is a resource covering the authorization of a type of medicinal product, item, treatment or service, from a regulatory point of view. It refers to generally being allowed to legally use that class of treatment, and not any specific use. (It is not directly related to security or permissions within a running application.)

Regulated items - those subject to local, regional or international legislation for their use - are subject to authorization procedures and outcomes. This is a general approval not related to any particular instance of use or any patient.

This may cover:

Overall marketing of medicinal products. The right to make drugs (or devices etc.) available to patients in general.

Approval for the manufacturing of medicinal products.

Authorisation to perform certain procedures, such as the right of a practitioner or organization to use sedation/anaesthesia or radiation therapy in general (unrelated to any specific instance of use).

Clinical Trial authorizations - overall approval for a certain trial to take place, or for parts of one - but not consent for individuals to be on the trial.

Recording whether a laboratory test is approved for use by a regulator (e.g. FDA, or a more local authority).

Out of scope:

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).

This resource is referenced by MedicinalProductDefinition, PackagedProductDefinition and itself.

This resource does not implement any patterns.

Structure

NameFlagsCard.TypeDescription & Constraintsdoco
.. RegulatedAuthorization ΣTUDomainResourceThe regulatory authorization of a type of medicinal item or service
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness identifier for the authorization, typically assigned by the authorizing body
... subject Σ0..1Reference(MedicinalProductDefinition | PackagedProductDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition)The type of product or service that is being authorized
... type Σ0..1CodeableConceptOverall type of this authorization, for example drug marketing approval, orphan drug designation
... region Σ0..*CodeableConceptThe region (country, jurisdiction etc.) in which the marketing authorization has been granted
... status Σ0..1CodeableConceptThe status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
... statusDate Σ0..1dateTimeThe date at which the given status became 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
... indication[x] Σ0..1Condition for which the medicinal use applies
.... indicationCodeableConceptCodeableConcept
.... indicationReferenceReference(ClinicalUseIssue)
... intendedUse Σ0..1CodeableConceptThe intended use of the product, e.g. prevention, treatment
... basis Σ0..*CodeableConceptThe legal or regulatory 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 by which this case can be referenced
.... type Σ0..1CodeableConceptThe defining type of case
.... status Σ0..1CodeableConceptThe status associated with the case
.... date[x] Σ0..1Relevant date for this 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 authorization, typically assigned by the authorizing bodyidentifier : Identifier [0..*]The type of product or service that is being authorizedsubject : Reference [0..1] « MedicinalProductDefinition| PackagedProductDefinition|DeviceDefinition|ResearchStudy| ActivityDefinition|PlanDefinition|ObservationDefinition »Overall type of this authorization, for example drug marketing approval, orphan drug designationtype : CodeableConcept [0..1]General textual supporting informationdescription : markdown [0..1]The region (country, jurisdiction etc.) in which the marketing authorization has been grantedregion : CodeableConcept [0..*]The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applicationsstatus : CodeableConcept [0..1]The date at which the given status became 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]Condition for which the medicinal use appliesindication[x] : DataType [0..1] « CodeableConcept|Reference( ClinicalUseIssue) »The intended use of the product, e.g. prevention, treatmentintendedUse : CodeableConcept [0..1]The legal or regulatory 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] : DataType [1..1] « Period|dateTime »Type of this date, for example the data exclusitity period for a medicinal producttype : CodeableConcept [1..1]CaseIdentifier by which this case can be referencedidentifier : Identifier [0..1]The defining type of casetype : CodeableConcept [0..1]The status associated with the casestatus : CodeableConcept [0..1]Relevant date for this of casedate[x] : DataType [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 authorization, typically assigned by the authorizing body --></identifier>
 <subject><!-- 0..1 Reference(ActivityDefinition|DeviceDefinition|
   MedicinalProductDefinition|ObservationDefinition|PackagedProductDefinition|
   PlanDefinition|ResearchStudy) The type of product or service 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 region (country, jurisdiction etc.) in which the marketing 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 given status became 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>
 <indication[x]><!-- 0..1 CodeableConcept|Reference(ClinicalUseIssue) Condition for which the medicinal use applies --></indication[x]>
 <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 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 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 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 authorization, typically assigned by the authorizing body
  "subject" : { Reference(ActivityDefinition|DeviceDefinition|
   MedicinalProductDefinition|ObservationDefinition|PackagedProductDefinition|
   PlanDefinition|ResearchStudy) }, // The type of product or service 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 region (country, jurisdiction etc.) in which the marketing 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 given status became 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
  // indication[x]: Condition for which the medicinal use applies. One of these 2:
  "indicationCodeableConcept" : { CodeableConcept },
  "indicationReference" : { Reference(ClinicalUseIssue) },
  "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!  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 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 }] // 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 authorization, typically assigned by the authorizing body
  fhir:RegulatedAuthorization.subject [ Reference(ActivityDefinition|DeviceDefinition|MedicinalProductDefinition|
  ObservationDefinition|PackagedProductDefinition|PlanDefinition|ResearchStudy) ]; # 0..1 The type of product or service 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 region (country, jurisdiction etc.) in which the marketing 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 given status became 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
  # RegulatedAuthorization.indication[x] : 0..1 Condition for which the medicinal use applies. One of these 2
    fhir:RegulatedAuthorization.indicationCodeableConcept [ CodeableConcept ]
    fhir:RegulatedAuthorization.indicationReference [ Reference(ClinicalUseIssue) ]
  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 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 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..* 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 type of medicinal item or service
Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension
... identifier Σ0..*IdentifierBusiness identifier for the authorization, typically assigned by the authorizing body
... subject Σ0..1Reference(MedicinalProductDefinition | PackagedProductDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition)The type of product or service that is being authorized
... type Σ0..1CodeableConceptOverall type of this authorization, for example drug marketing approval, orphan drug designation
... region Σ0..*CodeableConceptThe region (country, jurisdiction etc.) in which the marketing authorization has been granted
... status Σ0..1CodeableConceptThe status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
... statusDate Σ0..1dateTimeThe date at which the given status became 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
... indication[x] Σ0..1Condition for which the medicinal use applies
.... indicationCodeableConceptCodeableConcept
.... indicationReferenceReference(ClinicalUseIssue)
... intendedUse Σ0..1CodeableConceptThe intended use of the product, e.g. prevention, treatment
... basis Σ0..*CodeableConceptThe legal or regulatory 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 by which this case can be referenced
.... type Σ0..1CodeableConceptThe defining type of case
.... status Σ0..1CodeableConceptThe status associated with the case
.... date[x] Σ0..1Relevant date for this 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 authorization, typically assigned by the authorizing bodyidentifier : Identifier [0..*]The type of product or service that is being authorizedsubject : Reference [0..1] « MedicinalProductDefinition| PackagedProductDefinition|DeviceDefinition|ResearchStudy| ActivityDefinition|PlanDefinition|ObservationDefinition »Overall type of this authorization, for example drug marketing approval, orphan drug designationtype : CodeableConcept [0..1]General textual supporting informationdescription : markdown [0..1]The region (country, jurisdiction etc.) in which the marketing authorization has been grantedregion : CodeableConcept [0..*]The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applicationsstatus : CodeableConcept [0..1]The date at which the given status became 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]Condition for which the medicinal use appliesindication[x] : DataType [0..1] « CodeableConcept|Reference( ClinicalUseIssue) »The intended use of the product, e.g. prevention, treatmentintendedUse : CodeableConcept [0..1]The legal or regulatory 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] : DataType [1..1] « Period|dateTime »Type of this date, for example the data exclusitity period for a medicinal producttype : CodeableConcept [1..1]CaseIdentifier by which this case can be referencedidentifier : Identifier [0..1]The defining type of casetype : CodeableConcept [0..1]The status associated with the casestatus : CodeableConcept [0..1]Relevant date for this of casedate[x] : DataType [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 authorization, typically assigned by the authorizing body --></identifier>
 <subject><!-- 0..1 Reference(ActivityDefinition|DeviceDefinition|
   MedicinalProductDefinition|ObservationDefinition|PackagedProductDefinition|
   PlanDefinition|ResearchStudy) The type of product or service 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 region (country, jurisdiction etc.) in which the marketing 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 given status became 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>
 <indication[x]><!-- 0..1 CodeableConcept|Reference(ClinicalUseIssue) Condition for which the medicinal use applies --></indication[x]>
 <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 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 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 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 authorization, typically assigned by the authorizing body
  "subject" : { Reference(ActivityDefinition|DeviceDefinition|
   MedicinalProductDefinition|ObservationDefinition|PackagedProductDefinition|
   PlanDefinition|ResearchStudy) }, // The type of product or service 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 region (country, jurisdiction etc.) in which the marketing 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 given status became 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
  // indication[x]: Condition for which the medicinal use applies. One of these 2:
  "indicationCodeableConcept" : { CodeableConcept },
  "indicationReference" : { Reference(ClinicalUseIssue) },
  "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!  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 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 }] // 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 authorization, typically assigned by the authorizing body
  fhir:RegulatedAuthorization.subject [ Reference(ActivityDefinition|DeviceDefinition|MedicinalProductDefinition|
  ObservationDefinition|PackagedProductDefinition|PlanDefinition|ResearchStudy) ]; # 0..1 The type of product or service 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 region (country, jurisdiction etc.) in which the marketing 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 given status became 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
  # RegulatedAuthorization.indication[x] : 0..1 Condition for which the medicinal use applies. One of these 2
    fhir:RegulatedAuthorization.indicationCodeableConcept [ CodeableConcept ]
    fhir:RegulatedAuthorization.indicationReference [ Reference(ClinicalUseIssue) ]
  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 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 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..* 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
case-typetokenThe defining type of caseRegulatedAuthorization.case.type
holderreferenceMarketing Authorization HolderRegulatedAuthorization.holder
(Organization)
identifiertokenBusiness identifier for the authorization, typically assigned by the authorizing bodyRegulatedAuthorization.identifier
regiontokenThe region (country, jurisdiction etc.) in which the marketing authorization has been grantedRegulatedAuthorization.region
statustokenThe status that is authorised e.g. approved. Intermediate states can be tracked with cases and applicationsRegulatedAuthorization.status
subjectreferenceThe type of product or service that is being authorizedRegulatedAuthorization.subject
(MedicinalProductDefinition, DeviceDefinition, ObservationDefinition, PlanDefinition, PackagedProductDefinition, ResearchStudy, ActivityDefinition)