Renewals

The requirement to apply for a renewal procedure ceased to apply under Regulation (EU) 2019/6).

Marketing authorisations(MAs) granted after 28/01/2022 according to the Regulation (EU) 2019/6 will have an unlimited period of validity with the exception of MAs granted under the legal basis “limited markets” and “exceptional circumstances”. However, MAs granted according to Directive 2001/82/EC were granted for a limited period of 5 years. Please be referred to the Q&A document on transitional arrangements for the entry into application of Regulation (EU) 2019/6, which can be found on the CMDv website.

The guidance below applies to procedures still in progress under Directive 2001/82, only.

Guidance under Directive 2001/82/EC

Best practice guide on handling renewals in the Mutual Recognition and Decentralised Procedure