The MAHs of the active substances included in the “List of active substances involved in the pilot on signal detection in EudraVigilance by marketing authorisation holders” have to monitor in EudraVigilance the safety profile of the concerned substances in the context of signal detection activities and inform accordingly the European Medicines Agency and National Competent Authorities of validated signals, from 22 February 2018 for a pilot period of one year, following a three-month grace period to familiarize themselves with the new EudraVigilance system, with new tools to support EudraVigilance monitoring and to finalise their own processes. In this regard, Viglya is now prepared to meet this new obligation, fully aligned with the European Medicines Agency requirements.


Posted on the EMA website on 22 February 2018