{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-2/paragraph-14",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-2/paragraph-14.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/14",
  "kind": "paragraph",
  "number": "14",
  "heading": "Authorisation to manufacture specific veterinary medicinal products",
  "text": "(1) The Secretary of State may authorise a person to—\n(a) manufacture—\n(i) autogenous vaccines; or\n(ii) an unauthorised veterinary medicinal product for administration under the cascade;\n(b) collect, store and supply blood in connection with the treatment of non-food animals;\n(c) collect, store and supply blood constituents obtained by the physical separation of donor blood into different fractions within a closed bag system, for the treatment of non-food animals; or\n(d) collect, process and store stem cells for use as an autologous treatment in non-food animals,\nand may authorise sites for the purpose of carrying out those activities by that person.\n(2) A single authorisation under sub-paragraph (1) may confer permission to carry out the activities mentioned in both paragraph (b) and (c) of that sub-paragraph.\n(3) In this paragraph, a “closed bag system” means a system in which the blood pack assembly is manufactured under clean conditions, sealed to the external environment and sterilised.",
  "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/14",
    "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."
}