{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-4",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/regulation-4.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/4",
  "kind": "regulation",
  "number": "4",
  "heading": "Fee for scientific advice: application for, or variation to, EU marketing authorization",
  "text": "Unless regulation 5 applies, the fee payable by a person with whom the licensing authority holds a meeting in order to provide scientific advice with a view to that person making an application for an EU marketing authorization or an application for the variation of an EU marketing authorization, is—\n(a) £2,378, if the advice provided at that meeting consists of advice in connection with—\n(i) quality development only; or\n(ii) safety development only;\n(b) £2,986, if the advice provided at that meeting consists only of advice in connection with clinical development;\n(c) £3,309, if the advice provided at that meeting consists only of advice in connection with quality and safety development;\n(d) £3,917, if the advice provided at that meeting consists of advice in connection with—\n(i) quality and clinical development; or\n(ii) safety and clinical development;\n(e) £4,849, if the advice provided at that meeting consists of advice in connection with quality, safety and clinical development.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/nisr/2012/134/regulation/4",
    "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."
}