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:
The Regulation is applicable only for mutual recognition, decentralised and centralised procedures.
State Agency of Medicines - Nooruse 1, 50411 Tartu, Estonia | Tel: +372 7374140 | Fax: +372 7374142 | info@ravimiamet.ee | Location map