EudraVigilance Database (EV)

IMA is a Webtrader in the European Medicines Agency´s (EMA) database, EudraVigilance, and reports all adverse reactions received from healthcare professionals and the public to that database.

Marketing Authorisation Holders (MAHs) are required to register Individual Case Safety Reports (ICSRs) of cases occurring in Iceland electronically into EudraVigilance (EV) and send the report to ID = EVHUMAN.

Once a MAH has completed a test phase with EMA a test phase is not required to be completed with the IMA.