{
  "url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-45",
  "json_url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-45.json",
  "legislation": "ukdsi/2024/9780348258523",
  "legislation_title": "The Veterinary Medicines (Amendment etc.) Regulations 2024",
  "legislation_url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024",
  "path": "regulation/45",
  "kind": "regulation",
  "number": "45",
  "heading": "Amendment to paragraph 24",
  "text": "In paragraph 24(2) (refusal of a marketing authorisation)—\n(a) in paragraph (b) for “risk-benefit balance” substitute “benefit-risk balance”;\n(b) for paragraph (c) substitute—\n“(c) the applicant has not provided sufficient evidence of the efficacy of the product in relation to the target species;”;\n(c) after paragraph (f) insert—\n“(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;\n(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;\n(i) the risks to public or animal health or to the environment are not sufficiently addressed;\n(j) the qualitative or quantitative composition of the veterinary medicinal product is not as stated in the application;\n(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).”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2024/9780348258523/regulation/45",
    "retrieved_at": "2026-10-30T14:41:23.789053+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}