Guidance for Adverse Event Reporting
Guidance for companies on reporting of suspected adverse events to the EU pharmacovigilance database, known as EudraVigilance EudraVigilance Veterinary (EVVet) is the European data-processing network and database management system for the rapid and secure exchange of reports of suspected adverse events relating to veterinary medicines. This is mandatory for marketing authorisation holders (MAHs) in accordance with EU legislation. There are 3 different routes for sending reports to EVVet:
1. Gateway (registration with the EMA is required)
• Preferred option for MAHs 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 with the EMA 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 a report using standard terminology.
• The completed form is sent as an email attachment to the HPRA or other EU competent authority which then uploads the attachment directly into EVVet.
Additional guidance on the transmission options and tutorials are available on the EudraVigilance website.