How medicines are authorised in Europe

All medicines must be authorised before they can be sold in the EU. There are different routes for authorisation.

Centralised procedure

Companies can obtain a marketing authorisation valid throughout the EU. The application is submitted directly to the European Medicines Agency for assessment, which is carried out through the scientific expertise of the Member States. The centralised procedure is compulsory for particular categories of medicines and optional for others. Learn more about the centralised procedure. 

Decentralised procedure

Companies can apply for the simultaneous authorisation of a medicine in more than one EU Member State when it has not yet been authorised in any EU Member State, and it does not fall within the mandatory scope of the centralised procedure.

In this procedure, one country is requested to be the Reference Member State (RMS) while the other countries involved are known as the Concerned Member States (CMS).

Mutual recognition procedure

Companies that have a medicine authorised in one EU Member State can apply for this authorisation to be recognised in other EU countries. The Member States concerned agree to accept the validity of the original national marketing authorisation.

National procedure

Companies can apply for a marketing authorisation in one country where the product falls outside the scope of the centralised procedure. The application is submitted for assessment directly to the regulator in that country.