{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-125",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-125.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/125",
  "kind": "regulation",
  "number": "125",
  "heading": "Traditional herbal medicinal products",
  "text": "(1) This Part applies to a herbal medicinal product (a “traditional herbal medicinal product”) if the following conditions are met.\n(2) Condition A is met if by virtue of its composition and indications the product is appropriate for use without the need for a medical practitioner to—\n(a) diagnose the condition to be treated by the product;\n(b) prescribe the product; or\n(c) monitor the product's use.\n(3) Condition B is met if the product is intended to be administered at a particular strength and in accordance with a particular posology.\n(4) Condition C is met if the product is intended to be administered externally, orally or by inhalation.\n(5) Condition D is met if—\n(a) the product has been in medicinal use for a continuous period of at least 30 years, and\n(b) in relation to—\n(i) a THR(NI) or THR(UK), the product has been in medicinal use in the European Union for a continuous period of at least 15 years;\n(ii) a THR(GB), the product has been in medicinal use in the United Kingdom or a country included in the list published under regulation 125A(1) for a continuous period of at least 15 years.\n(6) It is immaterial for the purposes of condition D whether or not during a period mentioned in that condition—\n(a) the sale or supply of the product has been based on a specific authorisation; or\n(b) the number or quantity of the ingredients (or any of them) has been reduced.\n(7) Condition E is met if there is sufficient information about the use of the product as mentioned in condition D (referred to in this Part as its “traditional use”), so that (in particular)—\n(a) it has been established that the traditional use of the product is not harmful; and\n(b) the pharmacological effects or efficacy of the product are plausible on the basis of long-standing use and experience.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 125(5)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 110 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 82); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/125",
    "retrieved_at": "2026-10-29T01:24:34.993203+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."
}