The European Medicines Agency (EMA) has published a further Q and A document on the practical transitional measures for implementation of the new PV legislation.
The document provides information on areas such as the ADR reporting, PSURs, pharmacovigilance system master file, risk management plans and PASS in the period of transition from Volume 9a to the new legislation. A must-read for all Marketing Authorisation Holders!
The document can be found using the link below: