In the Official Journal of the European Union, the "Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products" was published. It supersedes the Commission Regulation (EC) No 1084/2003 on the mutual recognition agreement and the decentralised procedure as well as the Commission Regulation (EC) No. 1085/2003 concerning authorisations under the Centralised System.
Furthermore, it also applies to purely national marketing authorisations. However, here the variations directive published in October provides for a continued application of the national variations systems to marketing authorisations granted before 1 January 1998 (see our GMP News of 5 November 2008).
Under this link you can find the new regulation.
On the behalf of the European Compliance Academy (ECA)