EMA: Regulatory information – Green light for reliance on Article 57 database for key pharmacovigilance information on medicines for human use in Europe

29.12.2015

As of 1 February 2016, for both centrally and nationally authorised medicines, companies will no longer be required to submit type IA variations in relation to the Qualified Person Responsible for Pharmacovigilance and Pharmacovigilance System Master File.