Europe – EudraVigilance User Manual

Marketing Authorisation Holders - EudraVigilance access via the EudraVigilance Data Analysis System

This manual provides guidance for Marketing Authorisation Holders (MAHs) on the use of the EudraVigilance Data Analysis System (EVDAS) to retrieve information for level 1 access as established in the EMA policy on access to EudraVigilance data for medicinal products for human use (Referred in this manual as ‘the EudraVigilance access policy’) for stakeholder Group III1. These EVDAS reports permit MAHs to perform signal management activities and therefore comply with the pharmacovigilance obligations established in the Commission Implementing Regulation (EU) No 520/2012 and GVP Module IX on signal management…