Agence française de sécurité sanitaire des aliments (Afssa)/Agence nationale du médicament vétérinaire (ANMV), La Haute Marche, BP 90203, 35302 Fougères, France
- Key words: drug approval, environnemental exposure, legislation drug, risk assessment, toxic actions, veterinary drugs
- Page(s) : 315-9
- Published in: 2006
Evaluation of the environmental risk of veterinary drugs is based on Directive 2001/82/EC, as modified by Directive 2004/28/EC. These directives distinguish two stages in ecotoxicological risk assessment: first, exposure assessment, then effect evaluation. Two VICH (International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products) guidelines, which are not currently binding, make it possible to apply these directives and conduct a harmonized evaluation in member countries. Depending on the benefit/risk analysis, the veterinary drug is or is not approved for marketing, possibly under conditions for use intended to limit its ecotoxicological risk.