{
  "url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-57",
  "json_url": "https://openlegislation.uk/draft-veterinary-medicines-amendment-etc-regulations-2024/regulation-57.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/57",
  "kind": "regulation",
  "number": "57",
  "heading": "Amendment to paragraph 38",
  "text": "In paragraph 38 (suspension of marketing authorisation: grounds)—\n(a) for sub-paragraph (1) substitute—\n“(1) If the Secretary of State is satisfied at any time that the benefit-risk balance of a veterinary medicinal product is not positive or is insufficient to ensure food safety, the Secretary of State may—\n(a) suspend the marketing authorisation;\n(b) require the holder of the marketing authorisation to submit an application for its variation;\n(c) revoke the marketing authorisation.”;\n(b) for sub-paragraph (3) substitute—\n“(3) The Secretary of State may take the steps set out in sub-paragraph (1)(a), (b) and (c) on being satisfied at any time that—\n(a) information given in the application documents is incorrect;\n(b) any control tests required have not been carried out;\n(c) changes have been made to the manufacturing process without the authority of the Secretary of State;\n(d) any information required to be supplied to the Secretary of State has not been so supplied;\n(e) the holder of the marketing authorisation has failed to comply with the requirements of these Regulations;\n(f) the pharmacovigilance system in relation to a veterinary medicinal product is inadequate;\n(g) in the case of a generic authorisation, the reference product is updated to show a reduction in antimicrobial resistance;\n(h) the qualified person (pharmacovigilance) has failed to comply with the requirements of these Regulations”;\n(c) in the heading, after “suspension” insert “, revocation, etc”.",
  "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/57",
    "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."
}