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EMA: Updated EudraVigilance Registration Manual

EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA).

EudraVigilance supports safe and effective use of medicines by facilitating:

  • electronic exchange of individual case safety reports (ICSRs) between EMA, national competent authorities (NCAs), marketing authorisation holders (MAHs) and sponsors of clinical trials in the EEA;

  • early detection and evaluation of possible safety signals;

  • better product information for medicines authorised in the EEA.

This electronic reporting is obligatory for marketing authorisation holders and sponsors of clinical trials.

The EudraVigilance system includes:

  • a fully automated safety and message-processing mechanism using XML-based messaging;

  • a large pharmacovigilance database with query and tracking functions.

Yesterday EMA updated its EudraVigilance Registration Manual.

To set-up a new organisation in EudraVigilance Production or XCOMP (Test system), a series of steps need to be followed.

Click this LINK to know more about the Registration process with EudraVigilance Production system.


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