{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2005/schedule-1/paragraph-38",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2005/schedule-1/paragraph-38.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/38",
  "kind": "paragraph",
  "number": "38",
  "heading": "Suspension, etc., of a marketing authorisation",
  "text": "(1) The Secretary of State may suspend, vary or revoke a marketing authorisation at any time if she is satisfied that —\n(a) this is necessary for the protection of animal or public health or the environment;\n(b) the terms of the marketing authorisation have not been complied with;\n(c) the veterinary medicinal product has insufficient therapeutic effect.\n(2) She must suspend, vary or revoke a marketing authorisation if she is satisfied that—\n(a) the risk-benefit balance is unfavourable;\n(b) the withdrawal period does not ensure that residues in foodstuffs obtained from the treated animal comply with Council Regulation (EEC) No. 2377/90;\n(c) information given in the application documents is incorrect;\n(d) any control tests required have not been carried out;\n(e) changes have been made to the manufacturing process without the authority of the Secretary of State;\n(f) any information required to be supplied to the Secretary of State has not been communicated to her.\n(3) She may also suspend, vary or revoke a marketing authorisation if she is satisfied that a marketing authorisation holder has failed to make an application for a variation to take account of scientific and technical progress in manufacturing and control methods to enable a veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.\n(4) When she suspends, varies or revokes a marketing authorisation, the Secretary of State may additionally prohibit the supply of a veterinary medicinal product, and if necessary require the marketing authorisation holder to recall the product; and failure to comply with a requirement or prohibition under this sub-paragraph is an offence.\n(5) She shall publicise a revocation in such manner as she sees fit.",
  "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/38",
    "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."
}