3. Legal bodies responsible for regulatory procedures: Legal bodies responsible for regulatory procedures

3. Legal bodies responsible for regulatory procedures

View

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	Procedure	Scientific Assessment	Territorial scope
Commission	Centralised	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)

Help