Regulatory update – EMA encourages companies to submit type I variations for 2019 by end of November 2019

October 29, 2019 – The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA and type IAIN variations for 2019 no later than Friday 29 November 2019. This will enable EMA to acknowledge the validity of the submissions before the Agency’s closure between 23 December 2019 and 6 January 2020 and within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008. Marketing authorisation holders … (leggi tutto)