S.L. 437.47 Art. 13BActive substances.

In the case of veterinary medicinal products containing active substances used in the composition of authorized veterinary medicinal products but not hitherto used in combination for therapeutic purposes, the results of safety and residue tests, if necessary, and new pre-clinical tests or new clinical trials relating to that combination shall be provided in accordance with regulation 12(3)( but it shall not be necessary to provide scientific j), references relating to each individual active substance.