New Variation Regulation (EC) No 1234/2008  

17 December 09 print

The information on the new variation regulation (EC) No 1234/2008, related guidelines and new variation application form are available on the EC web-site:

http://ec.europa.eu/enterprise/sectors/pharmaceuticals/better-regulation-variations-regulations-developments_en.htm

The Regulation is applicable only for mutual recognition, decentralised and centralised procedures.