The European Medicines Agency has published an updated set of mandatory requirements for marketing authorisation holders to comply with Article 57(2), one of the key measures of the new pharmacovigilance legislation.


The Agency will continue to support marketing authorisation holders on the data submission process through online and face-to-face training and a dedicated helpdesk. An online data entry tool (EVWEB) hosted by the Agency to facilitate data submission by small and medium-sized enterprises was also released into production today.


Visit the EMA website for updated information.