{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-117",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-117.json",
  "legislation": "uksi/2019/775",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/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 THR(GB) (other than an application under the unfettered access route) 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": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 117 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 88"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 117 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2019/775/regulation/117",
    "retrieved_at": "2026-10-28T22:42:14.621781+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."
}