Veterinary medicinal products only receive marketing authorisation if the assessment of the data concerning their quality, safety and efficacy shows that the benefits linked to their use are greater than the risks incurred. The clinical trials conducted in the context of MA applications highlight a certain number of adverse effects which may occur when using medicinal products. However, these trials are conducted on a limited number of animals under standardised conditions of use. The large-scale use of a drug under real-life conditions once an MA is granted then makes it possible to precisely pinpoint the possible adverse effects of a product and to identify any potential risk factors (species, breed, age, pre-existing ailments, etc.).
Pharmacovigilance therefore aims to detect any emerging signs as quickly as possible, both unexpected adverse effects and known adverse effects with an unexpected frequency or severity. This post-MA monitoring sometimes results in adjusting risk management measures, which may include providing additional precautions for use on the package leaflet, or in certain cases withdrawal of the MA.
Here is a glimpse of the Agency's work on the topic.