EN PL

EMA: Guideline on demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish

17.05.2011
Veterinary medicinal products intended for use in finfish will have to satisfy all the usual requirements for approval. This includes documentation of quality, demonstration of safety for the consumer, the user and the environment, and demonstration of efficacy and tolerance in the target species. This document provides special guidance in respect of the documentation required to confirm efficacy and tolerance for medicinal products for use in finfish.The procedures outlined should be considered for all submissions, but may not be applicable for all veterinary medicinal products for use in aquaculture.