{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2005/schedule-1/paragraph-60",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2005/schedule-1/paragraph-60.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/60",
  "kind": "paragraph",
  "number": "60",
  "heading": "Action taken on account of pharmacovigilance",
  "text": "(1) Where, as a result of the evaluation of veterinary pharmacovigilance data, the Secretary of State considers that a marketing authorisation should be—\n(a) suspended;\n(b) revoked; or\n(c) varied so as to—\n(i) restrict the indications;\n(ii) change the distribution category;\n(iii) amend the dose;\n(iv) add a contraindication; or\n(v) add a new precautionary measure,\nshe shall forthwith inform the Agency, all other member States (irrespective of whether the product is authorised in another member State) and the marketing authorisation holder and shall ask for the opinion of the Agency.\n(2) If urgent action is necessary for protecting human or animal health, the Secretary of State may suspend the marketing authorisation of a veterinary medicinal product, but she must inform the Agency, the Commission and the other member States within one working day.\n(3) If, following the opinion of the Agency, the Commission requests the Secretary of State to suspend, withdraw or vary the marketing authorisation, the Secretary of State shall comply with that request immediately on a temporary basis.\n(4) The Secretary of State shall take final measures in accordance with the Decision of the Commission in accordance with Article 78(3) of Directive 2001/82/EC.",
  "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/60",
    "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."
}