This page is part of the FHIR Specification (v4.3.0: R4B - STU). 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
Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.
For an overview of this resource and others in the Medication Definition domain, also see the module page
RegulatedAuthorization is a resource covering the authorization of a type of regulated product, treatment, facility or activity.
Regulated products include animal and human drugs, devices, biologically derived, radiation-emitting, and nutritional products, software, etc. which are subject to local, regional or international legislation for their use.
Regulated treatments include emergency use of a regulated product, sedation/anesthesia or radiation therapy.
Regulated facilities include the storage, manufacturing, distribution, or any other regulated aspect for regulated products
Regulated activities include conducting a Clinical Trial e.g. either parts or the whole of a certain trial. Marketing regulated products to patients in general, manufacturing regulated products. Storage or distribution of controlled substances. Recording whether a laboratory test is approved for use by a regulator, etc.
This is a general authorization and is not related to any particular instance of use or any patient, therefore the following is out of scope for the resource:
Security authorizations - This resource is not directly related to "authorizations" as in permissions for users and actions in a security context.
Consent - which represents the choices and rights of an individual. Although there is a general legal right to give or withhold consent, consent is a record of a specific patients choice. This differs from the high level authorization of class of events or products to be used in general (within some legal framework), for any patient. The concepts are very broadly similar in concept, but are very different use cases in software terms, with little likelihood of confusion or overlap of implementation and properties.
Contract - a contract is a legal agreement between two entities about a specific arrangement. It is optionally entered into by the parties, but then binding. This is different from a generalised legal framework (law) that exists (e.g. legislation about controlled drugs), but is then applied to a series of instances of, say, drug types and organizations. A contract is more similar to the drug legislation itself, rather than the applications of it. However the legal frameworks themselves are mostly static and are not generally represented in clinical systems.
Authorizations of drugs - although the word is the same, the common concept of a physician authorizing a patient to have a certain drug (prescribing) is very different from the legal authorization to use that drug in a territory ("marketing authorization"). The context usually makes it very clear which is which (RegulatedAuthorization vs. MedicationRequest).
No resources refer to this resource directly.
This resource does not implement any patterns.
Structure
| Name | Flags | Card. | Type | Description & Constraints doco |
|---|---|---|---|---|
| .. RegulatedAuthorization | TU | DomainResource | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | |
| ... identifier | Σ | 0..* | Identifier | Business identifier for the authorization, typically assigned by the authorizing body |
| ... subject | Σ | 0..* | Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location) | The product type, treatment, facility or activity that is being authorized |
| ... type | Σ | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation RegulatedAuthorizationType (Example) |
| ... description | Σ | 0..1 | markdown | General textual supporting information |
| ... region | Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Jurisdiction (Example) |
| ... status | Σ | 0..1 | CodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications PublicationStatus (Preferred) |
| ... statusDate | Σ | 0..1 | dateTime | The date at which the current status was assigned |
| ... validityPeriod | Σ | 0..1 | Period | The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date |
| ... indication | Σ | 0..1 | CodeableReference(ClinicalUseDefinition) | Condition for which the use of the regulated product applies |
| ... intendedUse | Σ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment ProductIntendedUse (Preferred) |
| ... basis | Σ | 0..* | CodeableConcept | The legal/regulatory framework or reasons under which this authorization is granted RegulatedAuthorizationBasis (Example) |
| ... holder | Σ | 0..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator |
| ... regulator | Σ | 0..1 | Reference(Organization) | The regulatory authority or authorizing body granting the authorization |
| ... case | Σ | 0..1 | BackboneElement | The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) |
| .... identifier | Σ | 0..1 | Identifier | Identifier by which this case can be referenced |
| .... type | Σ | 0..1 | CodeableConcept | The defining type of case RegulatedAuthorizationCaseType (Example) |
| .... status | Σ | 0..1 | CodeableConcept | The status associated with the case PublicationStatus (Preferred) |
| .... date[x] | Σ | 0..1 | Relevant date for this case | |
| ..... datePeriod | Period | |||
| ..... dateDateTime | dateTime | |||
| .... application | Σ | 0..* | see case | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure |
doco Documentation for this format | ||||
UML Diagram (Legend)
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..* Reference(ActivityDefinition|BiologicallyDerivedProduct| DeviceDefinition|Location|MedicinalProductDefinition|NutritionProduct| ObservationDefinition|Organization|PackagedProductDefinition|PlanDefinition| Practitioner|ResearchStudy|SubstanceDefinition) The product type, treatment, facility or activity that is being authorized --></subject> <type><!-- 0..1 CodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation --></type> <description value="[markdown ]"/><!-- 0..1 General textual supporting information --> <region><!-- 0..* CodeableConcept The territory in which the authorization has been granted --></region> <status><!-- 0..1 CodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications --></status> <statusDate value="[dateTime ]"/><!-- 0..1 The date at which the current status was assigned --> <validityPeriod><!-- 0..1 Period The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date --></validityPeriod> <indication><!-- 0..1 CodeableReference(ClinicalUseDefinition) Condition for which the use of the regulated product applies --></indication> <intendedUse><!-- 0..1 CodeableConcept The intended use of the product, e.g. prevention, treatment --></intendedUse> <basis><!-- 0..* CodeableConcept The legal/regulatory framework or reasons under which this authorization is granted --></basis> <holder><!-- 0..1 Reference(Organization) The organization that has been granted this authorization, by the regulator --></holder> <regulator><!-- 0..1 Reference(Organization) The regulatory authority or authorizing body granting the authorization --></regulator> <case> <!-- 0..1 The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) --> <identifier><!-- 0..1 Identifier Identifier by which this case can be referenced --></identifier> <type><!-- 0..1 CodeableConcept The defining type of case --></type> <status><!-- 0..1 CodeableConcept The status associated with the case --></status> <date[x]><!-- 0..1 Period|dateTime Relevant date for this case --></date[x]> <application><!-- 0..* Content as for RegulatedAuthorization.case Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure --></application> </case> </RegulatedAuthorization>
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|BiologicallyDerivedProduct|
DeviceDefinition|Location|MedicinalProductDefinition|NutritionProduct|
ObservationDefinition|Organization|PackagedProductDefinition|PlanDefinition|
Practitioner|ResearchStudy|SubstanceDefinition) }], // The product type, treatment, facility or activity that is being authorized
"type" : { CodeableConcept }, // Overall type of this authorization, for example drug marketing approval, orphan drug designation
"description" : "<markdown >", // General textual supporting information
"region" : [{ CodeableConcept }], // The territory in which the authorization has been granted
"status" : { CodeableConcept }, // The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
"statusDate" : "<dateTime >", // The date at which the current status was assigned
"validityPeriod" : { Period }, // The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
"indication" : { CodeableReference(ClinicalUseDefinition) }, // Condition for which the use of the regulated product applies
"intendedUse" : { CodeableConcept }, // The intended use of the product, e.g. prevention, treatment
"basis" : [{ CodeableConcept }], // The legal/regulatory framework or reasons under which this authorization is granted
"holder" : { Reference(Organization) }, // The organization that has been granted this authorization, by the regulator
"regulator" : { Reference(Organization) }, // The regulatory authority or authorizing body granting the authorization
"case" : { // The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
"identifier" : { Identifier }, // Identifier by which this case can be referenced
"type" : { CodeableConcept }, // The defining type of case
"status" : { CodeableConcept }, // The status associated with the case
// date[x]: Relevant date for this case. One of these 2:
"datePeriod" : { Period },
"dateDateTime" : "<dateTime >",
"application" : [{ Content as for RegulatedAuthorization.case }] // Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
}
}
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|BiologicallyDerivedProduct|DeviceDefinition|Location| MedicinalProductDefinition|NutritionProduct|ObservationDefinition|Organization| PackagedProductDefinition|PlanDefinition|Practitioner|ResearchStudy| SubstanceDefinition) ], ... ; # 0..* The product type, treatment, facility or activity that is being authorized fhir:RegulatedAuthorization.type[ CodeableConcept ]; # 0..1 Overall type of this authorization, for example drug marketing approval, orphan drug designation fhir:RegulatedAuthorization.description[ markdown ]; # 0..1 General textual supporting information fhir:RegulatedAuthorization.region[ CodeableConcept ], ... ; # 0..* The territory in which the authorization has been granted fhir:RegulatedAuthorization.status[ CodeableConcept ]; # 0..1 The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications fhir:RegulatedAuthorization.statusDate[ dateTime ]; # 0..1 The date at which the current status was assigned fhir:RegulatedAuthorization.validityPeriod[ Period ]; # 0..1 The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date fhir:RegulatedAuthorization.indication[ CodeableReference(ClinicalUseDefinition) ]; # 0..1 Condition for which the use of the regulated product applies fhir:RegulatedAuthorization.intendedUse[ CodeableConcept ]; # 0..1 The intended use of the product, e.g. prevention, treatment fhir:RegulatedAuthorization.basis[ CodeableConcept ], ... ; # 0..* The legal/regulatory framework or reasons under which this authorization is granted fhir:RegulatedAuthorization.holder[ Reference(Organization) ]; # 0..1 The organization that has been granted this authorization, by the regulator fhir:RegulatedAuthorization.regulator[ Reference(Organization) ]; # 0..1 The regulatory authority or authorizing body granting the authorization fhir:RegulatedAuthorization.case[ # 0..1 The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) fhir: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 case. One of these 2 fhir:RegulatedAuthorization.case.datePeriod[ Period ] fhir:RegulatedAuthorization.case.dateDateTime[ dateTime ] fhir:RegulatedAuthorization.case.application[ See RegulatedAuthorization.case ], ... ; # 0..* Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure ]; ]
Structure
| Name | Flags | Card. | Type | Description & Constraints doco |
|---|---|---|---|---|
| .. RegulatedAuthorization | TU | DomainResource | Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product Elements defined in Ancestors: id, meta, implicitRules, language, text, contained, extension, modifierExtension | |
| ... identifier | Σ | 0..* | Identifier | Business identifier for the authorization, typically assigned by the authorizing body |
| ... subject | Σ | 0..* | Reference(MedicinalProductDefinition | BiologicallyDerivedProduct | NutritionProduct | PackagedProductDefinition | SubstanceDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition | Practitioner | Organization | Location) | The product type, treatment, facility or activity that is being authorized |
| ... type | Σ | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation RegulatedAuthorizationType (Example) |
| ... description | Σ | 0..1 | markdown | General textual supporting information |
| ... region | Σ | 0..* | CodeableConcept | The territory in which the authorization has been granted Jurisdiction (Example) |
| ... status | Σ | 0..1 | CodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications PublicationStatus (Preferred) |
| ... statusDate | Σ | 0..1 | dateTime | The date at which the current status was assigned |
| ... validityPeriod | Σ | 0..1 | Period | The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date |
| ... indication | Σ | 0..1 | CodeableReference(ClinicalUseDefinition) | Condition for which the use of the regulated product applies |
| ... intendedUse | Σ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment ProductIntendedUse (Preferred) |
| ... basis | Σ | 0..* | CodeableConcept | The legal/regulatory framework or reasons under which this authorization is granted RegulatedAuthorizationBasis (Example) |
| ... holder | Σ | 0..1 | Reference(Organization) | The organization that has been granted this authorization, by the regulator |
| ... regulator | Σ | 0..1 | Reference(Organization) | The regulatory authority or authorizing body granting the authorization |
| ... case | Σ | 0..1 | BackboneElement | The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) |
| .... identifier | Σ | 0..1 | Identifier | Identifier by which this case can be referenced |
| .... type | Σ | 0..1 | CodeableConcept | The defining type of case RegulatedAuthorizationCaseType (Example) |
| .... status | Σ | 0..1 | CodeableConcept | The status associated with the case PublicationStatus (Preferred) |
| .... date[x] | Σ | 0..1 | Relevant date for this case | |
| ..... datePeriod | Period | |||
| ..... dateDateTime | dateTime | |||
| .... application | Σ | 0..* | see case | Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure |
doco Documentation for this format | ||||
UML Diagram (Legend)
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..* Reference(ActivityDefinition|BiologicallyDerivedProduct| DeviceDefinition|Location|MedicinalProductDefinition|NutritionProduct| ObservationDefinition|Organization|PackagedProductDefinition|PlanDefinition| Practitioner|ResearchStudy|SubstanceDefinition) The product type, treatment, facility or activity that is being authorized --></subject> <type><!-- 0..1 CodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation --></type> <description value="[markdown ]"/><!-- 0..1 General textual supporting information --> <region><!-- 0..* CodeableConcept The territory in which the authorization has been granted --></region> <status><!-- 0..1 CodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications --></status> <statusDate value="[dateTime ]"/><!-- 0..1 The date at which the current status was assigned --> <validityPeriod><!-- 0..1 Period The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date --></validityPeriod> <indication><!-- 0..1 CodeableReference(ClinicalUseDefinition) Condition for which the use of the regulated product applies --></indication> <intendedUse><!-- 0..1 CodeableConcept The intended use of the product, e.g. prevention, treatment --></intendedUse> <basis><!-- 0..* CodeableConcept The legal/regulatory framework or reasons under which this authorization is granted --></basis> <holder><!-- 0..1 Reference(Organization) The organization that has been granted this authorization, by the regulator --></holder> <regulator><!-- 0..1 Reference(Organization) The regulatory authority or authorizing body granting the authorization --></regulator> <case> <!-- 0..1 The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) --> <identifier><!-- 0..1 Identifier Identifier by which this case can be referenced --></identifier> <type><!-- 0..1 CodeableConcept The defining type of case --></type> <status><!-- 0..1 CodeableConcept The status associated with the case --></status> <date[x]><!-- 0..1 Period|dateTime Relevant date for this case --></date[x]> <application><!-- 0..* Content as for RegulatedAuthorization.case Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure --></application> </case> </RegulatedAuthorization>
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|BiologicallyDerivedProduct|
DeviceDefinition|Location|MedicinalProductDefinition|NutritionProduct|
ObservationDefinition|Organization|PackagedProductDefinition|PlanDefinition|
Practitioner|ResearchStudy|SubstanceDefinition) }], // The product type, treatment, facility or activity that is being authorized
"type" : { CodeableConcept }, // Overall type of this authorization, for example drug marketing approval, orphan drug designation
"description" : "<markdown >", // General textual supporting information
"region" : [{ CodeableConcept }], // The territory in which the authorization has been granted
"status" : { CodeableConcept }, // The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
"statusDate" : "<dateTime >", // The date at which the current status was assigned
"validityPeriod" : { Period }, // The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
"indication" : { CodeableReference(ClinicalUseDefinition) }, // Condition for which the use of the regulated product applies
"intendedUse" : { CodeableConcept }, // The intended use of the product, e.g. prevention, treatment
"basis" : [{ CodeableConcept }], // The legal/regulatory framework or reasons under which this authorization is granted
"holder" : { Reference(Organization) }, // The organization that has been granted this authorization, by the regulator
"regulator" : { Reference(Organization) }, // The regulatory authority or authorizing body granting the authorization
"case" : { // The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
"identifier" : { Identifier }, // Identifier by which this case can be referenced
"type" : { CodeableConcept }, // The defining type of case
"status" : { CodeableConcept }, // The status associated with the case
// date[x]: Relevant date for this case. One of these 2:
"datePeriod" : { Period },
"dateDateTime" : "<dateTime >",
"application" : [{ Content as for RegulatedAuthorization.case }] // Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
}
}
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|BiologicallyDerivedProduct|DeviceDefinition|Location| MedicinalProductDefinition|NutritionProduct|ObservationDefinition|Organization| PackagedProductDefinition|PlanDefinition|Practitioner|ResearchStudy| SubstanceDefinition) ], ... ; # 0..* The product type, treatment, facility or activity that is being authorized fhir:RegulatedAuthorization.type[ CodeableConcept ]; # 0..1 Overall type of this authorization, for example drug marketing approval, orphan drug designation fhir:RegulatedAuthorization.description[ markdown ]; # 0..1 General textual supporting information fhir:RegulatedAuthorization.region[ CodeableConcept ], ... ; # 0..* The territory in which the authorization has been granted fhir:RegulatedAuthorization.status[ CodeableConcept ]; # 0..1 The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications fhir:RegulatedAuthorization.statusDate[ dateTime ]; # 0..1 The date at which the current status was assigned fhir:RegulatedAuthorization.validityPeriod[ Period ]; # 0..1 The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date fhir:RegulatedAuthorization.indication[ CodeableReference(ClinicalUseDefinition) ]; # 0..1 Condition for which the use of the regulated product applies fhir:RegulatedAuthorization.intendedUse[ CodeableConcept ]; # 0..1 The intended use of the product, e.g. prevention, treatment fhir:RegulatedAuthorization.basis[ CodeableConcept ], ... ; # 0..* The legal/regulatory framework or reasons under which this authorization is granted fhir:RegulatedAuthorization.holder[ Reference(Organization) ]; # 0..1 The organization that has been granted this authorization, by the regulator fhir:RegulatedAuthorization.regulator[ Reference(Organization) ]; # 0..1 The regulatory authority or authorizing body granting the authorization fhir:RegulatedAuthorization.case[ # 0..1 The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page) fhir: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 case. One of these 2 fhir:RegulatedAuthorization.case.datePeriod[ Period ] fhir:RegulatedAuthorization.case.dateDateTime[ dateTime ] fhir:RegulatedAuthorization.case.application[ See RegulatedAuthorization.case ], ... ; # 0..* Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure ]; ]
See the Profiles & Extensions and the alternate definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions & the dependency analysis
| Path | Definition | Type | Reference |
|---|---|---|---|
| RegulatedAuthorization.type | Example | RegulatedAuthorizationType | |
| RegulatedAuthorization.region | Example | Jurisdiction ValueSet | |
| RegulatedAuthorization.status | Preferred | PublicationStatus | |
| RegulatedAuthorization.intendedUse | Preferred | ProductIntendedUse | |
| RegulatedAuthorization.basis | Example | RegulatedAuthorizationBasis | |
| RegulatedAuthorization.case.type | Example | RegulatedAuthorizationCaseType | |
| RegulatedAuthorization.case.status | Preferred | PublicationStatus |
Search parameters for this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.