Guidance for Adverse Event Reporting  

Guidance for Marketing Authorisation Holders on Electronic Reporting of suspected adverse events to EudraVigilance

EudraVigilance Veterinary (EVVet) is the European data-processing network and database management system for the rapid and secure exchange of suspected adverse event reports relating to veterinary medicinal products. Electronic reporting of suspected adverse events to EVVet is mandatory for marketing authorisation holders (MAHs). Three different routes of sending reports to EVVet are available for use by MAHs:

1. Gateway (registration required)
• Preferred option for organisations exporting large volumes of data.
• MAHs work on a day-to-day basis with their local system for data input which is then securely distributed via the Gateway to EVVet.

2. EVWEB (registration required)
• Provides direct and secure access to EVVet over the internet.
• User is supplied with a username and password to open a web application that allows on-line data entry.

3. Simplified Electronic Reporting Form (no registration required)

• May be used by MAHs with limited experience in reporting adverse events.
• On-line form that allows user to create report using standard terminology.
• Completed form is sent as an email attachment to the competent authority which then uploads the attachment directly into EVVet.

Additional guidance on the transmission options and tutorials are available on the EudraVigilance website.