{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-42",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-42.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": "regulation/42",
  "kind": "regulation",
  "number": "42",
  "heading": "Fee for a review upon oral representations or a person appointed hearing",
  "text": "(1) A fee of £11,974 is payable by a person who gives notice, under any of the provisions specified in paragraph (2), of their wish to—\n(a) make further representations to the licensing authority or appear before or be heard by a person appointed, or\n(b) propose that there should be a review upon oral representations.\n(2) The specified provisions are—\n(a) in the Human Medicines Regulations—\n(i) regulation 27(3)(b) (procedure where licensing authority propose to suspend, revoke or vary licence);\n(ii) regulation 45H(5)(b) (procedure where licensing authority proposes to suspend or vary a broker's registration to remove a broker from the register);\n(iii) regulation 45R(5)(b) (procedure where licensing authority proposes to suspend or vary an active substance registration or remove the holder of an active substance registration from the register);\n(iv) regulation 256J(4)(b) (procedure where the competent authority of a member State proposes to suspend, vary or remove a person's entry on the list);\n(v) paragraphs 11(1), 13(1)(a), 23(2) and 30(2) of Schedule 11 (advice and representations);\n(vi) paragraph 3(8) of Schedule 32 (transitional provisions and savings in relation to product licences of right);\n(b) in the Clinical Trials Regulations—\n(i) paragraph 3(1)(a) of Schedule 5 (procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trial authorisations and the suspension or termination of clinical trials);\n(ii) paragraph 4(1)(a) of Schedule 8 (procedural provisions relating proposals to grant, refuse to grant, vary, suspend or revoke manufacturing authorisations).\n(3) The licensing authority will refund to that person—\n(a) 60% of that fee if the person withdraws the notice two weeks before the commencement of the hearing before the person appointed or the review upon oral representations;\n(b) 100% of that fee if, in respect of the hearing before the person appointed or the review upon oral representations, the decision notified by the licensing authority is—\n(i) not to revoke, vary, suspend or terminate, as the case may be, the authorisation, licence or certificate of registration;\n(ii) not to suspend, vary or remove, as the case may be, a person's entry on the list of online sellers of medicines; or\n(iii) to grant or renew, as the case may be, the authorisation, licence or certificate of registration.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sum in reg. 42(1) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 24"
    },
    {
      "type": "M",
      "label": "M1",
      "text": "Regulation 45H was inserted by S.I. 2013/1855."
    },
    {
      "type": "M",
      "label": "M2",
      "text": "Regulation 45R was inserted by S.I. 2013/1855."
    },
    {
      "type": "M",
      "label": "M3",
      "text": "Regulation 256J was inserted by S.I.2013/1855."
    },
    {
      "type": "M",
      "label": "M4",
      "text": "Schedule 5 was substituted by regulation 4 of, and paragraph 5 of Schedule 3 to, S.I. 2005/2754."
    },
    {
      "type": "M",
      "label": "M5",
      "text": "Paragraph 4 of Schedule 8 was substituted by regulation 4 of, and paragraph 6 of Schedule 3 to, S.I. 2005/2754."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/regulation/42",
    "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."
}