Division 3.4.2 Study of developmental toxicityF1

In the case of pharmacologically active substances or veterinary medicinal products intended for use in food-producing animals, tests on developmental toxicity shall be performed. These tests shall be designed to detect any adverse effects on the pregnant female and development of the embryo and foetus consequent to exposure of the female from implantation through gestation to the day before predicted birth. Such adverse effects include enhanced toxicity relative to that observed in non-pregnant females, embryo-foetal death, altered foetal growth, and structural changes to the foetus. A developmental toxicity test in the rat is required. Depending on the results, a study in a second species may have to be performed, in accordance with established guidance.

In the case of pharmacologically active substances or veterinary medicinal products not intended for use in food producing animals, a study of developmental toxicity shall be performed in at least one species, which may be the target species, if the product is intended for use in female animals which may be used for breeding. However, where the use of the veterinary medicinal product would result in significant exposure to users, standard developmental toxicity studies shall be performed.