Veterinary pharmacovigilance

Veterinary pharmacovigilance is the monitoring of user experiences. This is done on the basis of, among other things, notifications of adverse events and suspected adverse events. The reported adverse event is assessed and the possible cause is determined. This provides a basis for determining possible actions to prevent adverse events, or respond to them more effectively, such as the inclusion of an extra warning in the package leaflet.

As a marketing authorisation holder, you are legally obliged to submit reports of adverse events to the medicine authorities. There are detailed instructions on what needs to be reported and how this should be done. You are also responsible for making Periodic Safety Update Reports (PSURs) which you must submit periodically or at the request of the authorisation authority.

Before a veterinary medicine can be authorised and become available for use on animals, the Veterinary Medicinal Products Unit assesses whether it works effectively and can be used safely. During this assessment possible adverse events emerge before the veterinary medicine is authorised. These adverse events are listed in the package leaflet of the veterinary medicine.

However, unknown adverse events may still arise after the veterinary medicine has been authorised. Once the veterinary medicine has been marketed, user experiences of the veterinary medicine are monitored. By collecting these reports, more and more knowledge about the veterinary medicine becomes available. Based on this information, possible actions are laid down to prevent adverse events or deal with them better. This is referred to as veterinary pharmacovigilance.