Division 2 PharmacologyF1

Pharmacological studies are of fundamental importance in clarifying the mechanisms by which the veterinary medicinal product produces its therapeutic effects and therefore pharmacological studies conducted in experimental and target species of animal shall be included in Part 4.

However, pharmacological studies may also assist in the understanding of toxicological phenomena. Moreover, where a veterinary medicinal product produces pharmacological effects in the absence of a toxic response, or at doses lower than those required to elicit toxicity, these pharmacological effects shall be taken into account during the evaluation of the safety of the veterinary medicinal product.

Therefore the safety documentation shall always be preceded by details of pharmacological investigations undertaken in laboratory animals and all relevant information observed during clinical studies in the target animal.