{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-55",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-55.json",
  "legislation": "nisr/2012/134",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2012",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012",
  "path": "regulation/55",
  "kind": "regulation",
  "number": "55",
  "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 regulation—\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),\n(d) 44(8) (variation of manufacturing authorisation),\nfor “Medicines (Products for Human Use) (Fees) Regulations 2010” substitute “Medicines (Products for Human Use) (Fees) Regulations 2012”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "S.I. 2004/1031; relevant amendments are made by S.I. 2006/1928, 2010/551."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/nisr/2012/134/regulation/55",
    "retrieved_at": "2026-10-29T01:16:38.443269+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."
}