Division 3 ToxicologyF1

The documentation on toxicology shall follow the guidance published by the Agency on the general approach to testing and guidance on particular studies. This guidance includes:

1. 1..

   basic tests required for all new veterinary medicinal products for use in food-producing animals in order to assess the safety of any residues present in food for human consumption;

2. 2..

   additional tests that may be required depending on specific toxicological concerns such as those associated with the structure, class, and mode of action of the active substance(s);

3. 3..

   special tests which might assist in the interpretation of data obtained in the basic or additional tests.

The studies shall be conducted with the active substance(s), not with the formulated product. Where studies of the formulated product are required, this is specified in the text below.