{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2005/schedule-1/paragraph-24",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2005/schedule-1/paragraph-24.json",
  "legislation": "uksi/2005/2745",
  "legislation_title": "The Veterinary Medicines Regulations 2005",
  "legislation_url": "https://openlegislation.uk/veterinary-medicines-regulations-2005",
  "path": "schedule/1/paragraph/24",
  "kind": "paragraph",
  "number": "24",
  "heading": "Refusal of a marketing authorisation",
  "text": "(1) The Secretary of State shall refuse to grant a marketing authorisation if the application does not comply with these Regulations.\n(2) In addition, she shall refuse to grant it if—\n(a) the data submitted with the application are inadequate;\n(b) the risk-benefit balance of the veterinary medicinal product is unfavourable so that the risks outweigh the benefits;\n(c) the product has insufficient therapeutic effect;\n(d) the withdrawal period proposed by the applicant is not long enough to ensure that Council Regulation (EEC) No. 2377/90 is complied with, or is insufficiently substantiated;\n(e) the veterinary medicinal product is for a prohibited use;\n(f) the way that the product will be used will have an unnecessarily undesirable effect on the environment.\n(3) The Secretary of State may refuse a marketing authorisation—\n(a) if there is Community legislation pending that is incompatible with the requested authorisation; or\n(b) if she requests additional data and those data are not provided within such time limit as she may stipulate.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2005/2745/schedule/1/paragraph/24",
    "retrieved_at": "2026-10-29T04:49:34.048072+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."
}