EudraVigilance

Eudravigilance is a pan-European data-processing network and database management system for the exchange, processing and evaluation of adverse drug reactions (side effects) that may result following the use of one or several medicinal products. Particularly it is designed for the electronic transmission of Individual Case Safety Reports (ICSRs) related to medicinal products authorised in the European Community plus Iceland, Liechtenstein and Norway. The reporting of adverse drug reactions is defined in both local and EU legislation. The ongoing supervision of the safety of medicines is described as pharmacovigilance. For more information on this visit our how we monitor the safety of medicines page .

Eudravigilance acts as a central access point for pharmacovigilance data collected from within and outside Europe which allows Competent Authorities in each member state to share data on adverse drug reactions. Eudravigilance also provides the necessary evaluation tools to support the supervision of medicinal products through its Data Analysis System (EV-DAS).

For more information on Eudravigilance and EV-DAS please visit:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000679.jsp

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