{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-4/paragraph-9",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-4/paragraph-9.json",
  "legislation": "uksi/2013/2033",
  "legislation_title": "The Veterinary Medicines Regulations 2013",
  "legislation_url": "https://openlegislation.uk/veterinary-medicines-regulations-2013",
  "path": "schedule/4/paragraph/9",
  "kind": "paragraph",
  "number": "9",
  "heading": "Administration under an animal test certificate",
  "text": "(1) A medicinal product may be administered in accordance with an animal test certificate granted for clinical trials by the Secretary of State.\n(2) An application for an animal test certificate may be refused if this is necessary for the protection of animal or public health or the environment, and the animal test certificate may be varied, suspended or revoked in the same way as a marketing authorisation.\n(3) The holder of an animal test certificate may not supply a product for administration that is not within the terms of the animal test certificate.\n(4) The holder of an animal test certificate test who becomes aware of any adverse event following the administration of a product under an animal test certificate must report the reaction to the Secretary of State within 30 days of learning of it.",
  "extent": "E+W+S",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Sch. 4 para. 9(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 124(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in Sch. 4 para. 9(4) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 124(b)(i)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Sch. 4 para. 9(4) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 124(b)(ii)"
    },
    {
      "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/4/paragraph/9",
    "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."
}