The regulatory authorization of a medicinal product, device or process.

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

The type of product or service that is being authorized.

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

General textual supporting information.

The region (country, jurisdiction etc.) in which the marketing 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 given status became applicable.

The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.

Condition for which the medicinal use 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.

Other dates associated with the authorization. It is common for an authorization to have renewal dates, initial time limited phases and so on.

Another date associated with the authorization.

Type of this date, for example the data exclusitity period for a medicinal product.

Authorization in areas within a country.

The organization that holds the granted authorization.

Medicines Regulatory Agency.

The case or regulatory procedure for granting or amending a marketing authorization.

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.

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