Dear EudraVigilance Users,

Please allow us to inform you that essential EudraVigilance maintenance work on user and organisation management will be carried out on Tuesday 14th December 2021 from 07:00 to 17:30 CET. Should this need to be postponed, a new communication will be sent to inform the EudraVigilance users.

Electronic submission of ICSRs, AERs and XEVPRMs:

These maintenance activities will have negligible impact on the electronic submission of ICSRs and XEVPRMs via the EVWEB interface or the EV gateway: These message types can be submitted to EudraVigilance during this period; Message Delivery Notifications (MDN) will be returned as usual, but acknowledgement messages (ACKs) will only be returned after the completion of the maintenance work and the processing of the messages.

EVWEB reporting of ICSRs and AERs:

There is no impact on the availability of EVWEB for the reporting of ICSRs and ICSR forms from the EVDAS links to EVWEB will be available during this maintenance period. However, please note that you will need to access these applications directly rather than via the EV restricted area by using the URLs below:

EVWEB reporting of XEVPRMs and VEVPRMs:

The EVWEB functionality for electronic reporting of data on medicines (Article 57) to the XEVMPD and VEVMPD will be unavailable.

EudraVigilance restricted area:

The Human and Veterinary EudraVigilance restricted area will not be available during this period and a maintenance page will be displayed instead.

MAHs ICSR download requests:

Please note that it will not be possible to perform any ICSR download requests on that day from 07:00 to 17:30 CET. Please note that in the event this essential maintenance activity is taking longer than expected, the data being made available for L2A/B ICSR download might be delayed to the following day (please check the last processing date in the ICSR download tab of the EVWEB interface).

We thank you for your cooperation and understanding.