{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-117",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-117.json",
  "legislation": "ukdsi/2019/9780111179185",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019",
  "path": "regulation/117",
  "kind": "regulation",
  "number": "117",
  "heading": "Insertion of regulation 130A (procedure where less than 15 years use of traditional herbal medicinal product)",
  "text": "After regulation 130 (consideration of application) insert—\n“Procedure where less than 15 years use of traditional herbal medicinal product\n130A. (1) Where an application for a traditional herbal registration has been made and the licensing authority considers that—\n(a) the traditional herbal medicinal product does not satisfy regulation 125(5)(b) (Condition D); but\n(b) otherwise satisfies the conditions in regulation 125,\nthe licensing authority may refer the matter to the appropriate committee for relevant advice, and the procedure in Part 3 of Schedule 11 applies (referral to the appropriate committee for traditional herbal registrations).\n(2) In this regulation—\n“appropriate committee” has the same meaning as in paragraph 2(4) of Schedule 11;\n“relevant advice” means advice as to whether—\n(a) the conditions in regulation 125, other than condition D, are met in relation to the application; and\n(b) the licensing authority should exercise its powers under regulation 143A to establish a herbal monograph.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2019/9780111179185/regulation/117",
    "retrieved_at": "2026-10-30T15:01:32.040145+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."
}