Regulatory update – EMA encourages companies to submit type I variations for 2018 by end of November 2018

October 26, 2018 – The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IAIN and type IA variations for 2018 no later than Friday 30 November 2018. This will enable EMA to acknowledge the validity of the submissions before the Agency’s closure between 21 December 2018 and 2 January 2019 and within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008. Marketing authorisation … (leggi tutto)