Entering into force of Variation Regulation (EC) No 1234/2008 in Iceland

It is anticipated that the Regulation will be formally adopted in Iceland in the beginning of the year 2010

9.12.2009

On 4 December 2009 Commission Regulation (EC) No 1234/2008 was incorporated into the EEA Agreement (COMMISSION REGULATION (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products).

The Regulation will apply within the European Union Member States from 1 January 2010. New rules on applications for MA variations will be effective from the same date with concurrent new application forms for specified types of MAs, i.e. CP, DCP and MRP.

It is anticipated that the Regulation will be formally adopted in Iceland in the beginning of the year 2010, but due to Iceland´s participation in the Central, Decentralised and Mutual Recognition authorisation procedures, the handling of applications at the Icelandic Medicines Agency are foreseen to be in accordance with the said Regulation from 1 January 2010. The same Agency procedures would also apply to applications for variations to the terms of national marketing authorisations.