{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-28",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-28.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/28",
  "kind": "paragraph",
  "number": "28",
  "heading": "Records and supply of information",
  "text": "(1) A marketing authorisation holder must immediately inform the Secretary of State on receipt of any new information that might adversely affect the benefit-risk balance of the veterinary medicinal product.\n(2) The holder must immediately inform the Secretary of State of any prohibition or restriction imposed by the competent authorities of any country in which the veterinary medicinal product is authorised.\n(3) The Secretary of State may at any time require the marketing authorisation holder to provide data relating to the benefit-risk balance.\n(4) A marketing authorisation holder must retain all of the original documents from every clinical trial from which data was derived in support of the application for authorisation under this Schedule, and in support of any variation of the authorisation (whether granted or otherwise), for at least five years from the date on which the authorisation ceases.",
  "extent": "E+W+S",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Sch. 1 para. 28 substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 49(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sch. 1 para. 28(4) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 49(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Sch. 1 para. 28 heading inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 49(c)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/28",
    "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."
}