# The Veterinary Medicines (Amendment etc.) Regulations 2024, Regulation 45: Amendment to paragraph 24


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).”.

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Source: https://www.legislation.gov.uk/ukdsi/2024/9780348258523/regulation/45 (the official version)
Page: https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-45
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.