Definition

EU database and system for electronic submission and analysis of ICSRs; mandatory for MAHs in the EU.

Example

All serious valid ICSRs submitted to EudraVigilance with masking per Addendum II.

Regulatory source

EU Regulation 726/2004, GVP Module VI

Common mistakes

Late submission or unmasked data after July 2025.

Inspector question

How do you ensure timely and compliant EudraVigilance submission?

Related terms