Public access to suspected side effect reports of veterinary medicines

For the first time, EMA is making suspected side effect reports of veterinary medicines authorised in the European Union publicly accessible through the www.adrreports.eu website. The reports come directly from Eudravigilance Veterinary (EVVet), a database for processing pharmacovigilance reports which is used as one of several tools for regulators to monitor the benefit-risk balance of a veterinary medicine once it is authorised.

Information on suspected side effects for human medicines has been available via the same website since 2012. The launch of the extension of the website to include veterinary medicines safety information is part of the Agency's continuing efforts to ensure EU regulatory processes are transparent and open.

Suspected side effects are usually observed by veterinarians or pet owners. They are submitted electronically to EVVet - that collects reports of suspected serious adverse events in the EU as well as outside the EU - by national competent authorities or marketing authorisation holders.

The data published on www.adrreports.eu refers to approximately 250 centrally authorised veterinary medicines.

All information on the website relates to suspected side effects, i.e. medical events that have been observed following the use of a medicine, but which are not necessarily related to or caused by the medicine.

Making this information publicly available allows EMA’s stakeholders, including the general public, to access important data used by European regulatory authorities to review the safety of a veterinary medicine or active substance.

Upon accessing the website, web reports on adverse events can be searched by product name (for centrally authorised veterinary medicines) or by active substance. The data displayed pulls together the total number of individual serious spontaneous cases reported. Data can be filtered according to different categories such as species, breed, geographic origin and reaction group. It is also possible to view a detailed list of individual cases reported for each medicine or substance.

The website is currently available in English and will soon be available in all official EU languages.

*The text was updated on 12 February 2020 to correct the scope of data source.