As explained in Practice Note: Marketing Authorisations in the EU—regulatory procedures for approval of Medicinal Products, no medicinal product may be placed on the market without having first obtained an approval known as a marketing authorisation (MA). The MA sets out the medical conditions (known as indications), patient population and dosage for which the product is authorised as well as any conditions imposed on the marketing authorisation holder (MAH).

There are several different legal bases upon which an application for an MA can be made in the EU. This Practice Note explores the different types of marketing authorisation applications (MAAs) available in the EU and their legal bases as well as some practical considerations such as the content and form of an application for an MA, the Duration, validity, cessation and suspension of MAs.

For information about the licensing of medicinal products in the UK, see Practice Note: UK marketing authorisations for medicinal products.