RegulatedAuthorization

draftResource32 elementsv5.0.0

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.

Metadata

hl7.org/fhir

Canonical URL: http://hl7.org/fhir/StructureDefinition/RegulatedAuthorization
ID: RegulatedAuthorization
Type
Base Definition
Derivation: specialization
Publisher: Health Level Seven International (Biomedical Research and Regulation)
Version: 5.0.0

Path	Card.	Type	Description
`RegulatedAuthorization`	`0..*`		Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
`id`	`0..1`	string	Logical id of this artifact
`meta`	`0..1`	Meta	Metadata about the resource
`implicitRules`	`0..1`	uri	A set of rules under which this content was created
`language`	`0..1`	code	Language of the resource contentrequired: all-languages
`text`	`0..1`	Narrative	Text summary of the resource, for human interpretation
`contained`	`0..*`	Resource	Contained, inline Resources
`extension`	`0..*`	Extension	Additional content defined by implementations
`modifierExtension`	`0..*`	Extension	Extensions that cannot be ignored
`identifier`	`0..*`	Identifier	Business identifier for the authorization, typically assigned by the authorizing body
`subject`	`0..*`	Reference	The product type, treatment, facility or activity that is being authorized
`type`	`0..1`	CodeableConcept	Overall type of this authorization, for example drug marketing approval, orphan drug designationexample: regulated-authorization-type
`description`	`0..1`	markdown	General textual supporting information
`region`	`0..*`	CodeableConcept	The territory in which the authorization has been grantedexample: jurisdiction
`status`	`0..1`	CodeableConcept	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applicationspreferred: publication-status
`statusDate`	`0..1`	dateTime	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
`indication`	`0..*`	CodeableReference	Condition for which the use of the regulated product applies
`intendedUse`	`0..1`	CodeableConcept	The intended use of the product, e.g. prevention, treatmentpreferred: product-intended-use
`basis`	`0..*`	CodeableConcept	The legal/regulatory framework or reasons under which this authorization is grantedexample: regulated-authorization-basis
`holder`	`0..1`	Reference	The organization that has been granted this authorization, by the regulator
`regulator`	`0..1`	Reference	The regulatory authority or authorizing body granting the authorization
`attachedDocument`	`0..*`	Reference	Additional information or supporting documentation about the authorization
`case`	`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)