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.

Business identifier for the authorization, typically assigned by the authorizing body.

The product type, treatment, facility or activity that is being authorized.

Overall type of this authorization, for example drug marketing approval, orphan drug designation.

General textual supporting information.

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 date at which the current status was assigned.

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.

The intended use of the product, e.g. prevention, treatment.

The legal or regulatory framework against which this authorization is granted, or other reasons for it.

The organization that holds the granted 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.

Additional information or supporting documentation about the authorization.

The case or regulatory procedure for granting or amending a marketing 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 by which this case can be referenced.

The defining type of case.

The status associated with the case.

Relevant date for this of case.

Applications submitted to obtain a marketing authorization. Steps within the longer running case or procedure.