S.L. 437.47 Art. 4AVeterinary medicinal products for research purposes.

(1)A veterinary medicinal product may be obtained from any country and administered to animals for research purposes in accordance with article 53(3) of the Veterinary Services Act.

(2) The veterinary medicinal products authorised according this regulation may be exempt from the provisions of regulations 5, 6, 7 and 8.

(3) The veterinary medicinal products shall only be used in authorised research facilities which are in conformity with the Animal Welfare Act and the Protection of Animals for Scientific Purposes Regulations.

(4) (a) In order to be allowed to carry out the activity mentioned in sub-regulation (1) a person, herein referred to as the "applicant for a veterinary medicinal product to be used for research purposes", shall submit an application with the Veterinary Services.

(b) If the application is positively completed a licence for Research Purposes shall be issued. The Veterinary Services shall make, modify, add or remove any terms and conditions pertaining to the licence that it may deem fit in light of scientific advancements or new information that may emerge on particular substances or ingredients contained in the veterinary medicinal products used for research purposes.

(c) The holder of the licence for a veterinary medicinal product to be used for research purposes shall utilise a product or administer it to a test animal only under the terms and conditions set out under the Animal Welfare

Act.

(d) The holder of the licence for a veterinary medicinal product to be used for research purposes who becomes aware of any serious adverse reactions on the animal or on the person administering it shall report the reaction to the Veterinary Services within fifteen (15) days from the day the serious adverse reaction was discovered.

(e) Food for human consumption can be taken from test animals only in accordance with regulation 86 and with the prior approval of the Veterinary Services. (f) The application submitted by the applicant shall be granted without prejudice to any licence or permit that the applicant may need to obtain from other departments and directorates in order to engage in the indicated research activity.

(g) The applicant for a veterinary medicinal product or holder of the licence is subject to official inspections by the Veterinary Services on the premises and the activities undertaken within the premises.

(h) The Veterinary Services shall set out the criteria for veterinary medicinal product which are obtained in accordance with sub-regulation (1) and make them public.