EudraVigilance Veterinary - Registration

The registration process is necessary to identify the partners of the European Medicines Agency in the European Economic Area (EEA) for the secure electronic transmission of Adverse Event Reports (AERs). Only registered partners are permitted to exchange safety or acknowledgement messages through the EudraVigilance Veterinary Gateway and Database Management System (DBMS). Pharmaceutical Companies and National Competent Authorities can register on this website for the purpose of the secure electronic transmission of AERs and to become part of the EudraVigilance Veterinary user community. It is recommended to download and read the Guidance for registration with EudraVigilance Veterinary document.

On 26 November 2019, the European Medicines Agency (EMA) integrated the services of EudraVigilance (veterinary) with EMA's Account Management portal and Organisations Management Service (OMS). All users, including organisations, need an active EMA account created through the EMA Account Management portal.

EudraVigilance Veterinary has two different environments:

The Test Environment is for the testing of electronic transmission of AERs. Please refer to the Guidance for registration with EV VET – XCOMP system below. Access to the registration form for EV VET XCOMP system is available here.

The Production Environment is for the regular electronic transmission of AERs.

Please refer to the following documents for more information about the EudraVigilance Veterinary process:

The required registration forms are here:

IT vendors and third-party service providers who offer software solutions and services related to electronic reporting can register as gateway organisations with the EudraVigilance Veterinary XCOMP environment for testing purposes.

Registration allows users to submit test files to the XCOMP environment via a gateway connection only; no access to the EVWEB application will be possible.

For detailed instructions on how to register with XCOMP as a vendor, see:
Vendor Registration in the Eudravigilance external compliance testing environment (XCOMP)