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).”.