{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-264",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-264.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/264",
  "kind": "regulation",
  "number": "264",
  "heading": "Homoeopathic medicines",
  "text": "(1) The outer packaging and immediate packaging and, where a package leaflet is included, the package leaflet of a homoeopathic medicinal product must clearly include the words “homoeopathic medicinal product”.\n(2) The outer packaging and immediate packaging and, where a package leaflet is included, the package leaflet of a registrable homoeopathic medicinal product must also include the information specified in paragraph (1) and Part 1 of Schedule 28 and no other information (unless paragraph (5) or (6) applies).\n(3) Regulation (4) applies in a case where a package leaflet is not included with a registrable homoeopathic medicinal product.\n(4) Unless the context requires otherwise, any requirement of these Regulations that is expressed by reference to a package leaflet shall be taken to refer to—\n(a) the outer packaging or the immediate packaging of the product; or\n(b) in a case to which paragraph (5) or paragraph (6) applies, the outer packaging of the product.\n(5) Where the immediate packaging of a registrable homoeopathic medicinal product is in the form of a blister pack and is placed in outer packaging which complies with the requirements of this regulation and Part 1 of Schedule 28, the immediate packaging must include the information specified in this regulation and Part 2 of Schedule 28.\n(6) Where the immediate packaging of a registrable homoeopathic medicinal product is too small to display the information required by Part 1 of Schedule 28, the immediate packaging must include the information specified in this regulation and Part 3 of Schedule 28.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/264",
    "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."
}