{
  "url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-43",
  "json_url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-43.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/43",
  "kind": "regulation",
  "number": "43",
  "heading": "Amendment to paragraph 22",
  "text": "In paragraph 22 (grant of marketing authorisation)—\n(a) the existing text is renumbered as sub-paragraph (2);\n(b) above that text insert—\n“22. (1) The Secretary of State must, before granting a marketing authorisation—\n(a) verify that the data submitted complies with the requirements set out in these Regulations;\n(b) assess the application and data submitted in respect of the veterinary medicinal product; and\n(c) reach a conclusion in relation to the benefit-risk balance of granting a marketing authorisation in respect of the veterinary medicinal product.”.\n(c) below the existing text (renumbered as sub-paragraph (2)) insert—\n“(3) The Secretary of State must set out any terms and conditions in connection with placing the product on the market when granting a marketing authorisation.\n(4) Where the marketing authorisation relates to a veterinary medicinal product that contains an antimicrobial the Secretary of State may require the holder of the marketing authorisation to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive in relation to the development of antimicrobial resistance.”.",
  "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/43",
    "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."
}