New variation Regulation, (EC) No 1234/2008
Friday, November 20, 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).
In principle, the same rules as for DCP/MRP products will apply even for nationally approved medicinal products and the MPA’s Code of Statutes LVFS 2006:11 will be updated with reference to the new variation regulation (EC) 1234/2008. Information on when the new regulation will apply for nationally approved medicinal products will be published at this webpage shortly.
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. The aim is to have all documents ready by the end of November.
See Related information for more information.