Public Access to Side Effect Reports of Veterinary Drugs in the EU

17 February 2020

GMP News

For the first time, EMA is making suspected side effect reports of veterinary medicines authorised in the European Union publicly accessible through the 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.

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 refers to approximately 250 centrally authorised veterinary medicines.

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.




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