EMA: Submission of Type IA, Type IAin and Quality Type IB variations in December 2011

EMA will be closed between 23 December 2011 and 2 January 2012 (inclusive).

Marketing Authorisation Holders are therefore advised, where possible, not to submit Type IA and Type IAin variation applications to the EMA after 28 November 2011 because the 30-day timeframe for the Agency to acknowledge the validity of the submitted Type IA and Type IA in variation(s) (see article 14 of Commission Regulation (EC) No 1234/2008) would coincide with the official closure of the EMA. Marketing Authorisation Holders intending to apply for Quality Type IB variations in December 2011 are encouraged to liaise with the EMA prior to their submission.