{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-44",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-44.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": "schedule/2/paragraph/44",
  "kind": "paragraph",
  "number": "44",
  "heading": "Clinical trial authorisations",
  "text": "(1) The fee payable under regulation 19(1) in connection with a notice of amendment relating to amendment to the dossier accompanying a request for authorisation to conduct a clinical trial is—\n(a) £265 if the amendments relate to one of the parts of the dossier specified in sub-paragraph (2) only;\n(b) £530 if the amendments relate to two parts of the dossier specified in sub-paragraph (2) only; or\n(c) £795 if the amendments relate to all three parts of the dossier specified in sub-paragraph (2) only.\n(2) The parts of the dossier specified in sub-paragraph (1) are—\n(a) the part containing the summaries of the chemical, pharmaceutical and biological data relating to the medicinal product tested or used in the trial;\n(b) the part containing the summaries of the non-clinical, pharmacological and toxicology data on that product; and\n(c) the part containing the summaries of the available data from previous clinical trials of, and human experience with, that product.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/nisr/2012/134/schedule/2/paragraph/44",
    "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."
}