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Biomedical Research and Regulation Work Group | Maturity Level: 1 | Trial Use | Security 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
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
RegulatedAuthorization | ΣTU | DomainResource | The regulatory authorization of a type of medicinal item or service 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..1 | Reference(MedicinalProductDefinition | PackagedProductDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition) | The type of product or service that is being authorized |
type | Σ | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation |
description | Σ | 0..1 | markdown | General textual supporting information |
region | Σ | 0..* | CodeableConcept | The region (country, jurisdiction etc.) in which the marketing authorization has been granted |
status | Σ | 0..1 | CodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications |
statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable |
validityPeriod | Σ | 0..1 | Period | The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format |
indication[x] | Σ | 0..1 | Condition for which the medicinal use applies | |
indicationCodeableConcept | CodeableConcept | |||
indicationReference | Reference(ClinicalUseIssue) | |||
intendedUse | Σ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment |
basis | Σ | 0..* | CodeableConcept | The legal or regulatory framework against which this authorization is granted, or other reasons for it |
relatedDate | Σ | 0..* | BackboneElement | Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on |
date[x] | Σ | 1..1 | Another date associated with the authorization | |
datePeriod | Period | |||
dateDateTime | dateTime | |||
type | Σ | 1..1 | CodeableConcept | Type of this date, for example the data exclusitity period for a medicinal product |
jurisdictionalAuthorization | Σ | 0..* | Reference(RegulatedAuthorization) | Authorization in areas within a country |
holder | Σ | 0..1 | Reference(Organization) | Marketing Authorization Holder |
regulator | Σ | 0..1 | Reference(Organization) | Medicines Regulatory Agency |
case | Σ | 0..1 | BackboneElement | The case or regulatory procedure for granting or amending a marketing authorization |
identifier | Σ | 0..1 | Identifier | Identifier by which this case can be referenced |
type | Σ | 0..1 | CodeableConcept | The defining type of case |
status | Σ | 0..1 | CodeableConcept | The status associated with the case |
date[x] | Σ | 0..1 | Relevant date for this of case | |
datePeriod | Period | |||
dateDateTime | dateTime | |||
application | Σ | 0..* | see case | Applcations submitted to obtain a marketing authorization. Steps within the longer running case or procedure |
Documentation for this format |
UML Diagram (Legend)
XML Template
<RegulatedAuthorization xmlns="http://hl7.org/fhir"> <!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier Business identifier for the 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
{ "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/> . [ 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 ]; ]
Structure
Name | Flags | Card. | Type | Description & Constraints |
---|---|---|---|---|
RegulatedAuthorization | ΣTU | DomainResource | The regulatory authorization of a type of medicinal item or service 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..1 | Reference(MedicinalProductDefinition | PackagedProductDefinition | DeviceDefinition | ResearchStudy | ActivityDefinition | PlanDefinition | ObservationDefinition) | The type of product or service that is being authorized |
type | Σ | 0..1 | CodeableConcept | Overall type of this authorization, for example drug marketing approval, orphan drug designation |
description | Σ | 0..1 | markdown | General textual supporting information |
region | Σ | 0..* | CodeableConcept | The region (country, jurisdiction etc.) in which the marketing authorization has been granted |
status | Σ | 0..1 | CodeableConcept | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications |
statusDate | Σ | 0..1 | dateTime | The date at which the given status became applicable |
validityPeriod | Σ | 0..1 | Period | The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format |
indication[x] | Σ | 0..1 | Condition for which the medicinal use applies | |
indicationCodeableConcept | CodeableConcept | |||
indicationReference | Reference(ClinicalUseIssue) | |||
intendedUse | Σ | 0..1 | CodeableConcept | The intended use of the product, e.g. prevention, treatment |
basis | Σ | 0..* | CodeableConcept | The legal or regulatory framework against which this authorization is granted, or other reasons for it |
relatedDate | Σ | 0..* | BackboneElement | Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on |
date[x] | Σ | 1..1 | Another date associated with the authorization | |
datePeriod | Period | |||
dateDateTime | dateTime | |||
type | Σ | 1..1 | CodeableConcept | Type of this date, for example the data exclusitity period for a medicinal product |
jurisdictionalAuthorization | Σ | 0..* | Reference(RegulatedAuthorization) | Authorization in areas within a country |
holder | Σ | 0..1 | Reference(Organization) | Marketing Authorization Holder |
regulator | Σ | 0..1 | Reference(Organization) | Medicines Regulatory Agency |
case | Σ | 0..1 | BackboneElement | The case or regulatory procedure for granting or amending a marketing authorization |
identifier | Σ | 0..1 | Identifier | Identifier by which this case can be referenced |
type | Σ | 0..1 | CodeableConcept | The defining type of case |
status | Σ | 0..1 | CodeableConcept | The status associated with the case |
date[x] | Σ | 0..1 | Relevant date for this of case | |
datePeriod | Period | |||
dateDateTime | dateTime | |||
application | Σ | 0..* | see case | Applcations submitted to obtain a marketing authorization. Steps within the longer running case or procedure |
Documentation for this format |
XML Template
<RegulatedAuthorization xmlns="http://hl7.org/fhir"> <!-- from Resource: id, meta, implicitRules, and language --> <!-- from DomainResource: text, contained, extension, and modifierExtension --> <identifier><!-- 0..* Identifier Business identifier for the authorization, typically 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
{ "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/> . [ 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 ]; ]
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.
Name | Type | Description | Expression | In Common |
case | token | The case or procedure number | RegulatedAuthorization.case.identifier | |
case-type | token | The defining type of case | RegulatedAuthorization.case.type | |
holder | reference | Marketing Authorization Holder | RegulatedAuthorization.holder (Organization) | |
identifier | token | Business identifier for the authorization, typically assigned by the authorizing body | RegulatedAuthorization.identifier | |
region | token | The region (country, jurisdiction etc.) in which the marketing authorization has been granted | RegulatedAuthorization.region | |
status | token | The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications | RegulatedAuthorization.status | |
subject | reference | The type of product or service that is being authorized | RegulatedAuthorization.subject (MedicinalProductDefinition, DeviceDefinition, ObservationDefinition, PlanDefinition, PackagedProductDefinition, ResearchStudy, ActivityDefinition) |