Division CHAPTER I: PERFORMANCE OF TESTSF1

The safety documentation shall show:

1. (a)

   the potential toxicity of the veterinary medicinal product and any dangerous or undesirable effects which may occur under the proposed conditions of use in animals; these should be evaluated in relation to the severity of the pathological condition concerned;

2. (b)

   the potential harmful effects to man of residues of the veterinary medicinal product or substance in foodstuffs obtained from treated animals and what difficulties these residues may create in the industrial processing of foodstuffs;

3. (c)

   the potential risks which may result from the exposure of human beings to the veterinary medicinal product, for example during its administration to the animal;

4. (d)

   the potential risks for the environment resulting from the use of the veterinary medicinal product.

All results shall be reliable and valid generally. Whenever appropriate, mathematical and statistical procedures shall be used in designing the experimental methods and in evaluating the results. Additionally, information shall be provided regarding the therapeutic potential of the product and about the hazards connected with its use.

In some cases it may be necessary to test the metabolites of the parent compound where these represent the residues of concern.

An excipient used in the pharmaceutical field for the first time shall be treated like an active substance.