EudraVigilance

EudraVigilance is a common-European database containing information about adverse reactions experienced by people, animals and seen in clinical trials. The system has been operating since December 2001, but has been updated and expanded since January 2022.

You can find more information about EudraVigilance via the link in the box to the right.

All adverse reaction reports between drug regulatory authorities and pharmaceutical companies in the EU are submitted electronically via EudraVigilance using the common information standard E2B.

We began transferring adverse reaction reports electronically to the EudraVigilance system in the summer of 2002, and we were thus among the first institutions to become fully E2B compatible.

Companies can find information about electronic transfer of adverse reaction data to EudraVigilance in the menu to the left.