Division 1 General principles

The purpose of clinical trials is to demonstrate or substantiate the effect of the veterinary medicinal product after administration at the proposed dosage regimen via the proposed route of administration and to specify its indications and contra-indications according to species, age, breed and sex, its directions for use as well as any adverse reactions which it may have.

Experimental data shall be confirmed by data obtained under normal field conditions.

Unless justified, clinical trials shall be carried out with control animals (controlled clinical trials). The efficacy results obtained should be compared with those from the target animal species that have received a veterinary medicinal product authorised in the Community for the same indications for use in the same target animal species, or a placebo or no treatment. All the results obtained, whether positive or negative, shall be reported.

Established statistical principles shall be used in protocol design, analysis and evaluation of clinical trials, unless justified.

In the case of a veterinary medicinal product intended primarily for use as a performance enhancer, particular attention shall be given to:

1. (1)

   the yield of animal produce,

2. (2)

   the quality of animal produce (organoleptic, nutritional, hygienic and technological qualities),

3. (3)

   nutritional efficiency and growth of target animal species,

4. (4)

   general health status of the target animal species.