The xEVMPD is a comprehensive drug dictionary linking all products, variants, and synonyms for active substances that became mandatory on 2 July 2012 for all MA holders.
All submissions to the xEVMPD are via the online portal. The initial medicinal information required includes details of the MA, therapeutic indications, API data, excipient data, SmPCs, posology, method of administration, and more. It is part of the ongoing MAH’s responsibility to ensure these details are updated through formal notifications.
The PV directive also requires the development and implantation of a compliant PV systems integrated into the GMP QMS and under the control and management of a QPPV (Qualified Person for Pharmacovigilance). Failure to comply with these mandatory safety requirements will result in product withdrawal and regulator action.