{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-35",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-35.json",
  "legislation": "uksi/2016/190",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2016",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016",
  "path": "schedule/2/paragraph/35",
  "kind": "paragraph",
  "number": "35",
  "heading": "Traditional herbal registrations",
  "text": "(1) Subject to sub-paragraphs (3) to (6), the fee payable under regulation 12(1)(a) in connection with an application for a traditional herbal registration of a kind described in column 1 of the following table is the fee specified in the corresponding entry in column 2 of that table.\nFee for application for traditional herbal registration\nColumn 1\nColumn 2\nKind of application\nFee payable\n1. Complex registration application\n(a)\nin respect of a medicinal product containing a single active ingredient\n£5,899\n(b)\nin any other case\n£8,848\n2. Standard registration application\n(a)\nin respect of a medicinal product containing 3 or fewer active ingredients\n£2,950\n(b)\nin any other case\n£4,424\n3. Reduced registration application category II\n(a)\nin respect of a medicinal product containing 3 or fewer active ingredients\n£983\n(b)\nin any other case\n£1,476\n4. Reduced registration application category I\n(a)\nin respect of a medicinal product containing 3 or fewer active ingredients\n£657\n(b)\nin any other case\n£983\n5. Change of ownership application\n£592\n(2) Each reference in sub-paragraphs (3) to (6) to an amount payable under sub-paragraph (1) in respect of an application refers to the amount payable under that sub-paragraph in respect of an application of the kind in question.\n(3) Where an application relates to a medicinal product which contains one or more vitamins or minerals which are vitamins or minerals from a new source, a fee of—\n(a) £1,311, if European Pharmacopoeia certificates of suitability covering all the vitamins or minerals which are a vitamin or mineral from a new source have been submitted with the application; or\n(b) £2,622, in any other case,\nis payable in addition to the amount payable under sub-paragraph (1) in respect of that application.\n(4) Where an application relates to a medicinal product which contains one or more new excipients, an amount of £8,748 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.\n(5) Where an application relates to a medicinal product which contains one or more TSE risk excipients from a new source, an amount of £777 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.\n(6) Where an application relates to a medicinal product which is a sterile medicinal product, an amount of £2,622 is payable in addition to the amount payable under sub-paragraph (1) in respect of that application.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sum in Sch. 2 para. 35(1) Table Entry 1(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(a)(i)(aa)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sum in Sch. 2 para. 35(1) Table Entry 1(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(a)(i)(bb)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Sum in Sch. 2 para. 35(1) Table Entry 2(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(a)(ii)(aa)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Sum in Sch. 2 para. 35(1) Table Entry 2(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(a)(ii)(bb)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Sum in Sch. 2 para. 35(1) Table Entry 3(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(a)(iii)(aa)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Sum in Sch. 2 para. 35(1) Table Entry 3(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(a)(iii)(bb)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Sum in Sch. 2 para. 35(1) Table Entry 4(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(a)(iv)(aa)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Sum in Sch. 2 para. 35(1) Table Entry 4(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(a)(iv)(bb)"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Sum in Sch. 2 para. 35(1) Table Entry 5 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(a)(v)"
    },
    {
      "type": "F",
      "label": "F10",
      "text": "Sum in Sch. 2 para. 35(3)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(b)(i)"
    },
    {
      "type": "F",
      "label": "F11",
      "text": "Sum in Sch. 2 para. 35(3)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(b)(ii)"
    },
    {
      "type": "F",
      "label": "F12",
      "text": "Sum in Sch. 2 para. 35(4) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(c)"
    },
    {
      "type": "F",
      "label": "F13",
      "text": "Sum in Sch. 2 para. 35(5) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(d)"
    },
    {
      "type": "F",
      "label": "F14",
      "text": "Sum in Sch. 2 para. 35(6) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(12)(e)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/35",
    "retrieved_at": "2026-10-28T23:27:13.215121+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."
}