{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-2/paragraph-20",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-2/paragraph-20.json",
  "legislation": "uksi/2013/2033",
  "legislation_title": "The Veterinary Medicines Regulations 2013",
  "legislation_url": "https://openlegislation.uk/veterinary-medicines-regulations-2013",
  "path": "schedule/2/paragraph/20",
  "kind": "paragraph",
  "number": "20",
  "heading": "Authorisation in relation to products for administration under the cascade",
  "text": "(1) Subject to sub-paragraph (2), no person may manufacture a product for administration under the cascade that is the pharmaceutical equivalent of an authorised veterinary medicinal product.\n(2) The Secretary of State may authorise the manufacture of a product notwithstanding sub-paragraph (1) where there is difficulty in relation to the supply of the authorised veterinary medicinal product.\n(3) The holder of an authorisation under paragraph 14(1)(a)(ii) may not supply a product manufactured in accordance with that sub-paragraph other than to a veterinary surgeon who has prescribed the product under the cascade.\n(4) The holder of an authorisation under paragraph 14(1)(a)(ii) must—\n(a) provide a list of products manufactured in accordance with that sub-paragraph to the Secretary of State annually or at the request of the Secretary of State;\n(b) provide sales data for products supplied under sub-paragraph (3) at the request of the Secretary of State.\n(5) For the purposes of this paragraph, a product is the pharmaceutical equivalent of an authorised veterinary medicinal product if—\n(a) it has the same qualitative and quantitative composition in active substances; and\n(b) it has the same pharmaceutical form.",
  "extent": "E+W+S",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 2 Pt. 2 (paras. 14-25 entitled \"Authorisation of autogenous vaccines, blood-banks, stem cell centres and products manufactured under the cascade\") substituted for Sch. 2 Pt. 2 (paras. 14-19 entitled \"Authorisation of manufacturers of autogenous vaccines\"), Pt. 3 (paras. 20-24 entitled \"Authorisation of blood banks\"), Pt. 4 (paras. 25-29 entitled \"Authorisation of manufacturers of products for administration under the cascade\") and Pt. 5 (paras. 30-35 entitled \"Authorisation of equine stem cell centres\") (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 92"
    },
    {
      "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/2/paragraph/20",
    "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."
}