Pharmacovigilance for veterinary medicinal products
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.
ANSES publishes three reports on antimicrobial resistance and veterinary pharmacovigilance
ANSES publishes several reports on veterinary antimicrobial sales, animal antimicrobial resistance and veterinary pharmacovigilance.
2012 sales survey of antimicrobials
The French Agency for Veterinary Medicinal Products (ANSES-ANMV) has been monitoring veterinary antimicrobial sales since 1999. Along with bacterial resistance monitoring, the information gathered through this national monitoring scheme is indispensable for enabling antimicrobial resistance risks assessment. ANSES has been particularly active in this area for the last three years ...
Published on 21/10/2013 Read more
A surveillance scheme for the adverse effects of veterinary medicinal products has been in operation since 2002, and has provided an on-line declaration service since 2010. This drug monitoring plan makes it possible to detect adverse effects and to more effectively describe them in animals. Declaring adverse effects provides continuous monitoring of the risks and benefits of veterinary medicinal products after they have been placed on the market, and therefore promotes their safe use. Through your declarations, you help expand our knowledge of veterinary medicinal products, which in turn is of benefit to animals, their owners and all those involved in animal health.
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