Section 9: Veterinary pharmacovigilance

The purpose of veterinary pharmacovigilance is to monitor the effects of veterinary medicinal products, mainly their adverse effects on animals and humans, and the scientific evaluation of information collected for this purpose. It also aims to monitor the adverse effects on animals and humans resulting from the administration to an animal of a medicinal product for human use under the conditions provided for in a of 3° of article L….

Veterinary pharmacovigilance includes : 1° The reporting of adverse reactions to veterinary medicinal products and medicinal products for human use administered under the conditions provided for in a of 3° of article L. 5143-4; 2° Gathering available information on the inadequate efficacy of a veterinary medicinal product in relation to its intended efficacy, on its use outside the scope of the summary of product characteristics defined in article R. 5141-15,…

For veterinary medicinal products covered by a marketing authorisation or for homeopathic veterinary medicinal products covered by a registration, pharmacovigilance is carried out after the authorisation or registration has been issued.

For the purposes of this section, the following definitions shall apply 1° Adverse reaction: a noxious and unintended response occurring at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or for restoring, correcting or modifying physiological function; 2° Adverse reaction in humans: a noxious and unintended response in a human being following exposure to a veterinary medicinal product; 3° Serious adverse reaction: an adverse reaction…

The national veterinary pharmacovigilance system comprises : 1° The Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail ; 2° (Deleted) ; 3° The veterinary pharmacovigilance centres mentioned in Article R. 5141-101; 4° Pharmacists, veterinarians and members of other health professions, as well as companies operating veterinary medicinal products.