New variation Regulation, (EC) No 1234/2008
Wednesday, December 16, 2009
The new variation regulation (EC) No 1234/2008 applies from 1 January 2010 for medicinal products approved via the mutual recognition procedure (MRP), decentralized procedure (DCP) and the Centralised procedure. The new variation regulation replaces the former regulations: (EC) No 1084/2003 (MRP/DCP) and (EC) No 1085/2003 (centralised marketing authorisations).
For nationally approved medicinal products, the new variation regulation will apply from 1 January 2010 as well, but during at least January, the MPA accept to receive variation applications also according to the old rules (LVFS 2006:11). The MPA’s Code of Statutes LVFS 2006:11 will eventually be updated with reference to the new variation regulation (EC) No 1234/2008.
Work is currently on going to produce/revise guidelines, new variation application form etc., further information on these documents will be published at this webpage shortly.