{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-169",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-169.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/169",
  "kind": "regulation",
  "number": "169",
  "heading": "Mixing of general sale medicinal products",
  "text": "(A1) This regulation does not apply to an MM medicinal product or a POC medicinal product.\n(1) The prohibitions in regulation 46 (requirement for authorisation) do not apply to a medicinal product (“the product”) in respect of which the following conditions are met.\n(2) Condition A is that the product is manufactured by the mixing of authorised medicinal products with other authorised medicinal products, or with substances that are not medicinal products.\n(3) Condition B is that any authorised medicinal product that is so mixed is subject to general sale.\n(4) Condition C is that the product is manufactured by a person (“H”) who is the holder of a manufacturer's licence that—\n(a) relates specifically to the manufacture of medicinal products in accordance with this regulation; and\n(b) was granted or renewed not more than five years before the date on which the product is sold or supplied in accordance with paragraphs (5) and (6),\nand that the product is manufactured in accordance with the terms of that licence.\n(5) Condition D is that the product is sold or supplied by H to a person (“P”) for administration to P or to a member of P's household.\n(6) Condition E is that P is present and asks H to use H's judgment as to the treatment required.\n(7) Condition F is that no advertisement relating to the product is published by any person.\n(8) Condition G is that written records of the manufacture of the product and of the sale or supply of the product are maintained and are made available to the licensing authority or to the enforcement authority on request.\n(9) In this regulation, “authorised medicinal product” means a medicinal product that is the subject of—\n(a) a UK marketing authorisation ...;\n(b) a certificate of registration; or\n(c) a traditional herbal registration.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 169(A1) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 21"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 169(9)(a) substituted (31.12.2020) by S.I. 2019/775, reg. 136 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 104): 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 169(9)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 71"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/169",
    "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."
}