New EudraVigilance system and go-live plan

11.10.2017.

Information for marketing authorisation holders and sponsors of clinical trials

The European Medicines Agency (EMA) informs that on 22 November 2017, EMA will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA).

The change-over from the current to the new version of EudraVigilance requires the transfer of more than 11 million Individual Case Safety Reports (ICSR) from the post-authorisation phase and clinical trials, as well as associated information. To allow the accurate transfer of such a large volume of data, some functionalities of the EudraVigilance system will be entirely or partially unavailable for a period of ten working days, from 8 to 21 November 2017.

We invite all marketing authorisation holders (MAHs) and sponsors of clinical trials to read the document “EudraVigilance go-live plan”. In accordance with the document the State Agency of Medicines of Latvia (SAM) has chosen the “Option 1” (Pages 19–27 and 42–45), stating that submitting ICRS to the State Agency of Medicines of Latvia will not be possible from 8 November 2017. Hereafter the marketing authorisation holders will no longer have to provide these reports to national competent authority, but directly to EudraVigilance.

For ICSRs that could not be submitted electronically during the cutover period (from 8 to 21 November 2017) the following principles apply:

MAHs need to submit electronically to EudraVigilance Post-authorisation Module (EVPM) information on all serious suspected adverse reactions that occurred in the EEA and in third countries. The submission of ICSRs requiring reporting from 8 to 21 November (according to 15 days reporting timelines) should take place within 2 EMA business days following the go-live of EudraVigilance (from 22 to 24 November 2017).
MAHs need to submit electronically to EVPM information on all non-serious suspected adverse reactions that were reportable to national Competent Authorities (NCAs) in the EEA. The submission of non-serious ICSRs requiring reporting between 8 to 21 November should take place within 2 EMA business days following the go-live of EudraVigilance (from 22 to 24 November 2017).
EudraVigilance will reroute all the reports also to the State Agency of Latvia.
The reporting follows the simplified reporting rules as set out in GVP Module VI (revision 2).
MAHs need to use EVWEB functionalities to obtain access (and to download) reports of suspected adverse reactions from NCAs in the EEA.

Additional information is available in the document “EudraVigilance stakeholder change management plan” in English. More information can also be found on the website of EMA.