Posted by Michael Wonder on 25 Oct 2016
EMA encourages companies to submit Type I variations for 2016 by end of November
25 October 2016 - EMA to check validity of submissions by end 2016.
The European Medicines Agency (EMA) is advising marketing authorisation holders to submit any Type IAIN and Type IA variations for 2016 by Wednesday 30 November. This will enable the Agency to acknowledge the validity of the submissions before the Agency's closure between 23 December 2016 and 2 January 2017 within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008External link icon.
Marketing authorisation holders are also advised to submit any Type IB variations or groupings of Type IB and Type IA variations for a start of procedure in 2016 by 13 December 2016. For submissions received on or after 14 December 2016, the procedure may not start until January 2017.
