{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-61",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-61.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/61",
  "kind": "regulation",
  "number": "61",
  "heading": "Amendment of the Medicines for Human Use (Clinical Trials) Regulations 2004",
  "text": "(1) The Medicines for Human Use (Clinical Trials) Regulations 2004 are amended as follows.\n(2) In regulations—\n(a) 17(2)(b)(ii) (request for authorisation to conduct a clinical trial);\n(b) 24(10) (amendments by the sponsor);\n(c) 38(3)(b) (application for manufacturing authorisation); and\n(d) 44(8) (variation of manufacturing authorisation)\nfor “Medicines (Products for Human Use) (Fees) Regulations 2013” substitute “ Medicines (Products for Human Use) (Fees) Regulations 2016 ”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "M",
      "label": "M1",
      "text": "S.I. 2004/1031; relevant amendments are made by S.I. 2006/1928 and 2013/532."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/regulation/61",
    "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."
}