{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-128",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-128.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/128",
  "kind": "regulation",
  "number": "128",
  "heading": "Accompanying material",
  "text": "(1) The applicant for the grant of a traditional herbal registration other than a THR(GB) under the unfettered access route must provide the material specified in Schedule 12 in relation to the product.\n(1A) The applicant for the grant of a THR(GB) under the unfettered access route must provide—\n(a) the application form submitted in connection with the granting of the THR(NI) which authorises the sale or supply of the product in Northern Ireland;\n(b) a copy of all material submitted in support of the application for the THR(NI) which authorises the sale or supply of the product in Northern Ireland; and\n(c) a copy of the THR(NI) which authorises the sale or supply of the medicinal product in Northern Ireland,\ntogether with any material specified in Schedule 12 which is not included in the material specified in sub-paragraphs (a) to (c) in relation to the product.\n(2) The applicant must also, if requested by the licensing authority to do so, provide the licensing authority with material or information that the licensing authority reasonably considers necessary for considering the application.\n(3) If the application relates to a product that is contained in the list referred to in Article 16f(1) of the 2001 Directive where the application is for a THR(NI) or THR(UK), or the list established under regulation 126A where the application is for a THR(GB)—\n(a) the applicant does not need to provide the material referred to in paragraphs 16 to 20 of Part 1 of Schedule 12; and\n(b) paragraph (2) of this regulation does not apply.\n(4) Material that is submitted under this regulation must be submitted in accordance with Annex I to the 2001 Directive, so far as applicable to traditional herbal medicinal products.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 128(1)(1A) substituted for reg. 128(1) (31.12.2020) by S.I. 2019/775, reg. 114(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 85)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 128(3) inserted (31.12.2020) by S.I. 2019/775, reg. 114(3) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 85)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/128",
    "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."
}