RSS Feed

Forthcoming changes to accessing and managing EudraVigilance

The EudraVigilance system will undergo several updates over the next few months to improve its security and user management processes.

These updates include:

Multi-factor authentication (MFA): The European Medicines Agency (EMA) has already implemented MFA for some of its systems and plans to enable it for access to EudraVigilance in March 2023, followed by EVDAS in Q2 2023.

Update of the EudraVigilance Terms and Conditions of Use: Users must accept these new terms and conditions before accessing it.

Level 2B download functionality for MAHs will be updated: The Level L2B download form will be updated to include a captcha control to prevent automated downloading of case narratives.

Changes to the EMA account management portal: The update will require the QPPV/RP users and their trusted deputies to review the list of users within their organization and their access role twice a year and confirm whether the user should still have access or not. The initial demonstration run will allow users to get familiar with the review process, and users will not lose access if the review is not completed within the set time frame. However, the official review process will revoke access automatically for unassessed users if the review is not completed within the one-month time frame and will be scheduled to be performed twice a year in March and September.

It’s important for organizations to note that they are responsible for removing user access if a user leaves their organization or changes their role within the organization where access to EudraVigilance data is no longer needed. This update is an additional control to the normal day-to-day user management that each organization should perform.