S.L. 437.115 Art. 6Authorisation for research and development purposes.        Cap. 439. S.L. 439.20.

(1) Veterinary medicinal products, investigational veterinary medicinal products and active substances shall not be used for research and development purposes unless the Director grants such authorisation to the applicant.

(2) The applicants requesting authorisation to use veterinary medicinal products, investigational veterinary medicinal products and, or active substances for research and development purposes shall submit an application in the form provided by the Director before the activity takes place and shall pay the relevant fee.

(3) Veterinary medicinal products authorised in accordance with this regulation may be exempt from the requirements established by Articles 5, 88 and 99 of Regulation (EU) 2019/6.

(4) Active substances authorised in accordance with this regulation may be exempted from the requirements established by Article 95 of Regulation (EU) 2019/6.

(5) The authorisation granted in accordance with this regulation shall be valid for a period of three (3) years.

(6) An authorisation in accordance with this regulation shall be granted without prejudice to any authorisation, licence or permit that the applicant may need to obtain from another entity in order to engage in the research activity involving veterinary medicinal product, investigational veterinary medicinal products or active substances.

(7) The Director may establish, amend, add or remove any terms and conditions pertaining to the authorisation that he may deem fit in light of scientific advancements or new information that may arise, from time to time.

(8) If applicable, the holder of the authorisation in accordance with this regulation shall administer the product to the test animal after obtaining prior authorisation from the relevant entity and only in accordance with the terms and conditions set out in the Animal

Welfare Act and the Protection of Animals used for Scientific Purposes

Regulations.

(9) Unless a withdrawal period is determined, test animals administered veterinary medicinal products, investigational veterinary medicinal products and active substances authorised in accordance with this regulation shall be excluded permanently from the food chain.

(10) The holder of an authorisation in accordance with this regulation shall notify the Director within fifteen (15) days of becoming aware of any adverse reactions on the animal or on the person administering the products or substances in terms of this regulation:

Provided that the records provided for in this regulation shall be kept by the holder of an authorisation in accordance with this regulation for a period of five (5) years and shall be made available to the Director upon his request.

(11) The Director may carry out inspections on the premises and the activities being carried out on the premises by the holder of the authorisation.