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.

RegulatedAuthorization
identifier
Business identifier for the authorization, typically assigned by the authorizing body
subject
The product type, treatment, facility or activity that is being authorized
type
Overall type of this authorization, for example drug marketing approval, orphan drug designation
description
General textual supporting information
region
The territory in which the authorization has been granted
status
The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
statusDate
The date at which the current status was assigned
validityPeriod
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
Condition for which the use of the regulated product applies
intendedUse
The intended use of the product, e.g. prevention, treatment
basis
The legal/regulatory framework or reasons under which this authorization is granted
holder
The organization that has been granted this authorization, by the regulator
regulator
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 by which this case can be referenced
type
The defining type of case
status
The status associated with the case
date[x]
Relevant date for this case
application
Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure