REQUIREMENTS ON CLINICAL TRIALS FOR VETERINARY PHARMACEUTICAL PRODUCTS FOR FISH

Abstract

Veterinary pharmaceutical products intended for use in fish should comply with all usual requirements regarding approval for marketing, according to the Order of the President of the National Sanitary Veterinary Agency and for Food Safety No.187/2007, with subsequent amendments and additions. According to the legislation the technical file should containe documentation of quality, safety of animals, consumer, user and environment and demonstration of efficacy and tolerance in the target species. This paper provides the important information on requirements for demonstration on efficacy of pharmaceutical products indended for use in fish. The principal aim of the efficacy data is to prove the therapeutic value of pharmaceutical products and to establish an optimal dose and period of dose administration. In efficacity clinical trial is needed, also, to take into account, the various conditions such as climatic aspects, disease situation, water temperature and salinity, because these may influence the outcome and veracity of the studies.

Keywords

• clinical trials
• fish
• recquirements
• pharmaceutical products