Authorisation of medicinal products

Pharmaceutical companies can apply for a marketing authorisation for a medicinal product in four different ways:

The centralised procedure in which new and high-technology medicinal products are authorised in the entire EU simultaneously. The European Medicines Agency (EMEA) is responsible for this procedure. In turn, the individual Member States are responsible for the scientific evaluation of applications. The centralised procedure is compulsory for biotechnological medicinal products and orphan drugs.

The decentralised procedure (DCP) in which companies can apply for authorisation in more than one EU (EEA) country simultaneously and for which no EU (EEA) country has granted a national authorisation. The Reference Member State (RMS) is responsible for the procedure and for the scientific evaluation of the application.

The mutual recognition authorisation procedure (MRP) in which the marketing authorisation for a medicinal product, which has already been authorised in accordance with the national procedure in one EU (EEA) country (the Reference Member State), forms the basis for authorisation in another EU (EEA) country. The Reference Member State (RMS) is responsible for the procedure and the scientific evaluation of the application.

The national authorisation procedure in which the medicinal product is exclusively authorised in one Member State . At a later date, the authorisation may form the basis of an application via the mutual recognition procedure.

Contact the Licensing Division