{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-33A/paragraph-55",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-33A/paragraph-55.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/33A/paragraph/55",
  "kind": "paragraph",
  "number": "55",
  "heading": "Proposals to refer an application for a traditional herbal registration to the Committee for Herbal Medicinal Products and the procedure in Part 3 of Schedule 11 that were on-going at IP completion day",
  "text": "(1) This paragraph applies where—\n(a) the licensing authority has proposed to refer an application for a traditional herbal registration to be in force in Great Britain only to the Committee on Herbal Medicinal Products in accordance with Article 16c(4) of the 2001 Directive before IP completion day; but\n(b) that application has not been determined in accordance with Part 7 of these Regulations before IP completion day.\n(2) Where the licensing authority has received an opinion of the Committee for Herbal Medicinal Products before IP completion day in relation to the application, it must take that decision in to account and determine that application.\n(3) Where the licensing authority has not received an opinion of the Committee for Herbal Medicinal Products before IP completion day, notwithstanding the amendments made to Part 3 of Schedule 11 by the EU Exit Regulations, it may—\n(a) proceed to determine the application, taking into account any proceedings that took place before IP completion day under Part 3 of Schedule 11 (prior to its amendment by the EU Exit Regulations), or any opinion of the Committee on Herbal Medicinal Products in relation to the application that is given on or after IP completion day; or\n(b) it may refer the matter under regulation 130A in order to obtain the findings and advice of the appropriate committee before determining the application.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 33A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 7 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 193); 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/schedule/33A/paragraph/55",
    "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."
}