Generated Narrative: StructureDefinition ext-R4B-RegulatedAuthorization Name Flags Card. Type Description & Constraints Extension 0..* Extension(4.0.1) Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:type 0..1 Extension Overall type of this authorization, for example drug marketing approval, orphan drug designation #xD; url 1..1 uri "type" #xD; value[x] 0..1 CodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: R4B_regulated_authorization_type_for_R4 (0.0.1-snapshot-2) (example): Overall type of this authorization. #xD; extension:description 0..1 Extension General textual supporting information #xD; url 1..1 uri "description" #xD; value[x] 0..1 markdown General textual supporting information #xD; extension:region 0..* Extension The territory in which the authorization has been granted #xD; url 1..1 uri "region" #xD; value[x] 0..1 CodeableConcept The territory in which the authorization has been granted Binding: R4B_jurisdiction_for_R4 (0.0.1-snapshot-2) (example): Jurisdiction codes #xD; extension:status 0..1 Extension The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications #xD; url 1..1 uri "status" #xD; value[x] 0..1 CodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: PublicationStatus (preferred): The lifecycle status of an artifact. #xD; extension:statusDate 0..1 Extension The date at which the current status was assigned #xD; url 1..1 uri "statusDate" #xD; value[x] 0..1 dateTime The date at which the current status was assigned #xD; extension:validityPeriod 0..1 Extension 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 #xD; url 1..1 uri "validityPeriod" #xD; value[x] 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 #xD; extension:indication 0..1 Extension Condition for which the use of the regulated product applies #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:concept 0..1 Extension Reference to a concept (by class) #xD; url 1..1 uri "concept" #xD; value[x] 0..1 CodeableConcept Reference to a concept (by class) #xD; extension:reference 0..1 Extension Reference to a resource (by instance) #xD; url 1..1 uri "reference" #xD; value[x] 0..1 Reference() Reference to a resource (by instance) #xD; extension:_datatype 0..1 (Complex) Data type name for RegulatedAuthorization.indication from FHIR R4B URL: http://hl7.org/fhir/StructureDefinition/_datatype #xD; value[x] 1..1 string Value of extension Fixed Value: CodeableReference #xD; url 1..1 uri "indication" #xD; extension:intendedUse 0..1 Extension The intended use of the product, e.g. prevention, treatment #xD; url 1..1 uri "intendedUse" #xD; value[x] 0..1 CodeableConcept The intended use of the product, e.g. prevention, treatment Binding: R4B_product_intended_use_for_R4 (0.0.1-snapshot-2) (preferred): The overall intended use of a product. #xD; extension:basis 0..* Extension The legal/regulatory framework or reasons under which this authorization is granted #xD; url 1..1 uri "basis" #xD; value[x] 0..1 CodeableConcept The legal/regulatory framework or reasons under which this authorization is granted Binding: R4B_regulated_authorization_basis_for_R4 (0.0.1-snapshot-2) (example): A legal or regulatory framework against which an authorization is granted, or other reasons for it. #xD; extension:holder 0..1 Extension The organization that has been granted this authorization, by the regulator #xD; url 1..1 uri "holder" #xD; value[x] 0..1 Reference() The organization that has been granted this authorization, by the regulator #xD; extension:regulator 0..1 Extension The regulatory authority or authorizing body granting the authorization #xD; url 1..1 uri "regulator" #xD; value[x] 0..1 Reference() The regulatory authority or authorizing body granting the authorization #xD; <a href="StructureDefinition-ext-R4B-RegulatedAuthorization-definitions.html#Extension.extension:case" title="Slice case: The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page).">extension:case 0..1 Extension 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) #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:identifier 0..1 Extension Identifier by which this case can be referenced #xD; url 1..1 uri "identifier" #xD; value[x] 0..1 Identifier Identifier by which this case can be referenced #xD; extension:type 0..1 Extension The defining type of case #xD; url 1..1 uri "type" #xD; value[x] 0..1 CodeableConcept The defining type of case Binding: R4B_regulated_authorization_case_type_for_R4 (0.0.1-snapshot-2) (example): The type of a case involved in an application. #xD; extension:status 0..1 Extension The status associated with the case #xD; url 1..1 uri "status" #xD; value[x] 0..1 CodeableConcept The status associated with the case Binding: PublicationStatus (preferred): The lifecycle status of an artifact. #xD; extension:date[x] 0..1 Extension Relevant date for this case #xD; url 1..1 uri "date[x]" #xD; value[x] 0..1 Relevant date for this case #xD; valuePeriod Period #xD; valueDateTime dateTime #xD; <a href="StructureDefinition-ext-R4B-RegulatedAuthorization-definitions.html#Extension.extension:case.extension:application" title="Slice application: A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.">extension:application 0..* Extension Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Closed by value:url #xD; extension:_datatype 0..1 (Complex) Data type name for RegulatedAuthorization.case.application from FHIR R4B URL: http://hl7.org/fhir/StructureDefinition/_datatype #xD; value[x] 1..1 string Value of extension Fixed Value: RegulatedAuthorization.case #xD; url 1..1 uri "application" #xD; url 1..1 uri "case" #xD; url 1..1 uri "http://hl7.org/fhir/4.3/StructureDefinition/extension-RegulatedAuthorization" #xD; Documentation for this format
Cross-version Extension for R4B.RegulatedAuthorization for use in FHIR R4
This cross-version extension represents RegulatedAuthorization from http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization|4.3.0 for use in FHIR R4.
Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
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.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
Must have either extensions or value[x], not both
exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])
Overall type of this authorization, for example drug marketing approval, orphan drug designation
This cross-version extension represents RegulatedAuthorization.type from http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization|4.3.0 for use in FHIR R4.
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Source of the definition for the extension code - a logical name or a URL.
The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
This cross-version extension represents RegulatedAuthorization.description from http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization|4.3.0 for use in FHIR R4.
The territory in which the authorization has been granted
The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.
The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.
The date at which the current status was assigned
This cross-version extension represents RegulatedAuthorization.statusDate from http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization|4.3.0 for use in FHIR R4.
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
The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.
Condition for which the use of the regulated product applies
This cross-version extension represents RegulatedAuthorization.indication from http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization|4.3.0 for use in FHIR R4.
A reference to a concept - e.g. the information is identified by its general class to the degree of precision found in the terminology.
A reference to a resource the provides exact details about the information being referenced.
Data type name for RegulatedAuthorization.indication from FHIR R4B
Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list).
Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R4/extensibility.html) for a list).
The intended use of the product, e.g. prevention, treatment
The intended use of the product, e.g. prevention, treatment, diagnosis.
The legal/regulatory framework or reasons under which this authorization is granted
The legal or regulatory framework against which this authorization is granted, or other reasons for it.
A legal or regulatory framework against which an authorization is granted, or other reasons for it.
The organization that has been granted this authorization, by the regulator
The organization that has been granted this authorization, by some authoritative body (the 'regulator').
The regulatory authority or authorizing body granting the authorization
The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.
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)
The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. 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 by which this case can be referenced
This cross-version extension represents RegulatedAuthorization.case.identifier from http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization|4.3.0 for use in FHIR R4.
This cross-version extension represents RegulatedAuthorization.case.type from http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization|4.3.0 for use in FHIR R4.
The type of a case involved in an application.
This cross-version extension represents RegulatedAuthorization.case.status from http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization|4.3.0 for use in FHIR R4.
This cross-version extension represents RegulatedAuthorization.case.date[x] from http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization|4.3.0 for use in FHIR R4.
Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.
Data type name for RegulatedAuthorization.case.application from FHIR R4B