{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-7",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-7.json",
  "legislation": "uksi/2013/2033",
  "legislation_title": "The Veterinary Medicines Regulations 2013",
  "legislation_url": "https://openlegislation.uk/veterinary-medicines-regulations-2013",
  "path": "schedule/1/paragraph/7",
  "kind": "paragraph",
  "number": "7",
  "heading": "Bibliographic application",
  "text": "(1) An applicant for a marketing authorisation need not provide the results of safety tests, residue tests, pre-clinical trials or clinical trials if the applicant demonstrates that the active substances of the veterinary medicinal product have been in well-established veterinary use for at least 10 years, that their efficacy is documented and that they provide an acceptable level of safety.\n(1A) Sub-paragraph (1) does not apply to applications for—\n(a) biological (including immunological) veterinary medicinal products;\n(b) novel therapies.\n(2) The applicant may use any publicly available document.\n(3) If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies, together with further clinical trials, a third party may not use those studies or trials in an application for a pharmacologically equivalent product for a period of three years from the grant of the authorisation for the additional species.",
  "extent": "E+W+S",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Sch. 1 para. 7(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 31(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sch. 1 para. 7(1A) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 31(b)"
    },
    {
      "type": "E",
      "label": "E1",
      "text": "This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/7",
    "retrieved_at": "2026-10-29T00:44:44.019972+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."
}