{
  "url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-63",
  "json_url": "https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-63.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/63",
  "kind": "paragraph",
  "number": "63",
  "heading": "Placing a homeopathic remedy on the market in accordance with a registration",
  "text": "(1) By way of derogation from the provisions of these Regulations requiring a marketing authorisation for a veterinary medicinal product, a homeopathic remedy may be placed on the market in accordance with a registration by the Secretary of State instead of in accordance with a marketing authorisation if it complies with this paragraph.\n(2) It must not be an immunological or, subject to sub-paragraph (2A), a biological product.\n(2A) Sub-paragraph (2) does not apply in relation to a homeopathic remedy which is derived from plants.\n(3) The route of administration must be either topical or oral and must be as described in the European Pharmacopoeia....\n(4) There must be a sufficient degree of dilution to guarantee the safety of the product, and in any event it must not contain more than one part in 10,000 of the mother tincture.\n(5) All other provisions relating to marketing authorisations apply in the same way to registrations of a homeopathic remedy.",
  "extent": "E+W+S",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in Sch. 1 para. 63(2) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 75(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sch. 1 para. 63(2A) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 75(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in Sch. 1 para. 63(3) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 75(c)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in Sch. 1 para. 63(3) omitted (E.W.S.) (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(31) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "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/63",
    "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."
}