{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-20",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-20.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/20",
  "kind": "regulation",
  "number": "20",
  "heading": "Fees for modifications to clinical trial authorisations",
  "text": "(1) A person who sends a modification request under regulation 22 (modifications by the sponsor) of the Clinical Trials Regulations relating to amendment of the protocol or the dossier related to a request for authorisation in accordance with paragraphs 2 or 5(a) of Part A1 of Schedule 3 (request for approval) to those Regulations must pay the fees mentioned in paragraph (2).\n(2) The fees referred to in paragraph (1) are—\n(a) the fee prescribed in paragraph 49 of Schedule 2 in connection with that amendment; and\n(b) in respect of an inspection of a site made in connection with the application, the fee payable in accordance with regulations 30, 32, 33, 35 and 37.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 20(1) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 43(2)(b)(i)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 20(1) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 43(2)(b)(ii)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Word in reg. 20 heading substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 43(2)(a)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/regulation/20",
    "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."
}