Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions

In summary, the simplified electronic reporting of suspected adverse reactions related to medicines by national Competent Authorities and marketing authorisation holders to EudraVigilance becomes mandatory six months after the functionalities of the EudraVigilance database have been established and have been announced by the Agency i.e. 22 November 2017.

Please, read the Announcement of the EMA Management Board