A variation is a change to the dossier of an authorised product.
As from 1 January 2010, the Variation Regulation 1234/2008
applies to all veterinary medicines that have been authorised
via the centralised procedure or via a mutual recognition
procedure (MRP or DCP). This facilitates the implementation
of simple variations for authorisation dossiers for marketing
Please note: Since 1 January 2010, the regulation has also been
implemented for all nationally authorised veterinary medicines.
If you have any questions about the new Variations Regulation
1234/2008 please send an e-mail to: firstname.lastname@example.org.
The CMD(v) has revised the Best Practice Guides for type
IA, type IB and type II variations and has compiled the Best
Practice Guides for grouping and work-sharing procedures. These
publications can be found via: www.hma.eu/163.html.