New pharmacovigilance rules in effect in EU

New pharmacovigilance legislation took effect in the EU on Monday, putting in place rules adopted by the European Parliament and members states in December 2010. Under the legislation, the existing EudraVigilance database will be the single point of receipt for all pharmacovigilance information from companies and national authorities. Companies are now required to submit risk management plans for MAAs submitted to EMA. The plans should include activities to identify, characterize, prevent or minimize risks relating to a medicinal product, as well as an assessment of the effectiveness of the activities and interventions. ...