RegulatedAuthorization

Trial Use 2 Specialized — Medication Definition

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.

Endpoints

devhttps://api.sandbox.ovok.com/fhir/R5/RegulatedAuthorization

Interaction	Method	Path
Read	GET	/fhir/R5/RegulatedAuthorization/[id]
Vread	GET	/fhir/R5/RegulatedAuthorization/[id]/_history/[vid]
Update	PUT	/fhir/R5/RegulatedAuthorization/[id]
Patch	PATCH	/fhir/R5/RegulatedAuthorization/[id]
Delete	DELETE	/fhir/R5/RegulatedAuthorization/[id]
Create	POST	/fhir/R5/RegulatedAuthorization
Search	GET	/fhir/R5/RegulatedAuthorization?...
History	GET	/fhir/R5/RegulatedAuthorization/[id]/_history
Type-history	GET	/fhir/R5/RegulatedAuthorization/_history

Top-level elements

Element	Type(s)	Cardinality	Description
identifier	Identifier	0..*	Business identifier for the authorization, typically assigned by the authorizing body
subject	Reference	0..*	The product type, treatment, facility or activity that is being authorized
type	CodeableConcept	0..1	Overall type of this authorization, for example drug marketing approval, orphan drug designation
description	markdown	0..1	General textual supporting information
region	CodeableConcept	0..*	The territory in which the authorization has been granted
status	CodeableConcept	0..1	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
statusDate	dateTime	0..1	The date at which the current status was assigned
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
indication	CodeableReference	0..*	Condition for which the use of the regulated product applies
intendedUse	CodeableConcept	0..1	The intended use of the product, e.g. prevention, treatment
basis	CodeableConcept	0..*	The legal/regulatory framework or reasons under which this authorization is granted
holder	Reference	0..1	The organization that has been granted this authorization, by the regulator
regulator	Reference	0..1	The regulatory authority or authorizing body granting the authorization
attachedDocument	Reference	0..*	Additional information or supporting documentation about the authorization
case	BackboneElement	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)

Resource-specific search parameters

Parameter	Type	Description
case	token	The case or procedure number
case-type	token	The defining type of case
holder	reference	The organization that holds the granted authorization
identifier	token	Business identifier for the authorization, typically assigned by the authorizing body
region	token	The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted
status	token	The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
subject	reference	The type of regulated product, treatment, facility or activity that is being authorized

Reference

• Official FHIR R5 spec: RegulatedAuthorization
• Maturity: Trial Use 2 (FMM 2).