Procedural update on submission of Type I variations to EMA in March, April and May 2019

February 26, 2019 – EMA is encouraging marketing authorisation holders (MAHs) intending to submit Brexit-related Type IA and Type IB variations in March 2019 to file these variations as early as possible during the month. This will enable EMA to process the submissions before 29 March so that MAHs can receive confirmation of compliance with the regulatory and legal requirements before this date. Type I variations are minor changes to the marketing authorisation … (leggi tutto)