3. Legal bodies responsible for regulatory procedures


1. Legal bodies responsible for regulatory procedures

In the EU, a medicine for human use may be authorised either by the European Commission through the centralised procedure or by national competent authorities through a mutual recognition, decentralised or national procedure:

Authorising body


Scientific Assessment

Territorial scope



European Medicines Agency (EMA) through its committees

EU +EEA States Liechtenstein, Norway, Iceland

National competent authorities

Mutual Recognition*, Decentralised*, National

National competent authorities
(in case of disagreement additional assessment by the EMA)

EU countries concerned

* These procedures are overseen by the Heads of Medicines Agencies (HMA) via the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDH)