In the case of new veterinary medicinal products containing active substances used in the composition of authorised veterinary medicinal products but not hitherto used in combination for therapeutic purposes, the results of safety and residue tests and of pre-clinical and clinical trials relating to that combination shall be provided, but it shall not be necessary to provide the documentation relating to each individual active substance.

4. The competent authorities shall draw up an assessment report and comments on the dossier as regards the results of the pharmaceutical, safety and residue tests and the pre-clinical and clinical trials of the veterinary medicinal product concerned.

1. By way of derogation from point (j) of the first subparagraph of Article 12(3), and without prejudice to the law on the protection of industrial and commercial property, the applicant shall not be required to provide the results of the safety and residue tests or of the pre-clinical and clinical trials if he/she can demonstrate that the active substance(s) of the veterinary medicinal product are of well-established veterinary use for not less than ten years in the Community, with recognised efficacy and an acceptable level of safety in accordance with the conditions set out in Annex I. In that event the applicant shall provide approp ...[+++]riate scientific documentation.

Post-marketing surveillance studies : Pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorization, conducted with the aim of identifying and investigating a safety hazard relating to an authorized veterinary medicinal product.

15. Post-marketing surveillance studies: Pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorization, conducted with the aim of identifying and investigating a safety hazard relating to an authorized veterinary medicinal product.

3. In cases where the veterinary medicinal product does not fall under the definition of a generic medicinal product set out in paragraph 2(b) or where bio-equivalence cannot be demonstrated through bioavailability studies or in the case of changes to the active substance(s), therapeutic indications, strength, pharmaceutical form or route of administration vis-à-vis the reference medicinal product, the results of the appropriate safety and residue tests and pre-clinical tests or clinical trials shall be provided.