The Veterinary Medicines (Amendment etc.) Regulations 2024

Amendment to paragraph 24

45.  In paragraph 24(2) (refusal of a marketing authorisation)—

(a) in paragraph (b) for “risk-benefit balance” substitute “benefit-risk balance”;

(b) for paragraph (c) substitute—

“(c) the applicant has not provided sufficient evidence of the efficacy of the product in relation to the target species;”;

(c) after paragraph (f) insert—

“(g) the veterinary medicinal product is a veterinary medicinal product which contains an antimicrobial which is presented for use in order to promote the growth of treated animals or to increase yields from treated animals;

(h) the risk for public health in case of development of antimicrobial resistance or antiparasitic resistance outweighs the benefits of the veterinary medicinal product to animal health;

(i) the risks to public or animal health or to the environment are not sufficiently addressed;

(j) the qualitative or quantitative composition of the veterinary medicinal product is not as stated in the application;

(k) the active substance within the veterinary medicinal product meets the criteria for being considered persistent, bio-accumulative and toxic and the veterinary medicinal product is intended to be used in food-producing animals (except where it is demonstrated that the active substance is essential to prevent or control a serious risk to animal health).”.