{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-19",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-19.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/19",
  "kind": "regulation",
  "number": "19",
  "heading": "Fees for amendments to clinical trial authorisations",
  "text": "(1) A person who sends a valid notice of amendment under regulation 24 (amendments by the sponsor) of the Clinical Trial Regulations relating to amendment of the dossier accompanying a request for authorisation in accordance with paragraph 11 of Part 2 of Schedule 3 (request for authorisation) 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 44 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 27 to 29 and 31.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "Regulation 24 has been amended 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/19",
    "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."
}