{
  "url": "https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-human-use-regulations-1989/schedule-3/paragraph-2",
  "json_url": "https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-human-use-regulations-1989/schedule-3/paragraph-2.json",
  "legislation": "uksi/1989/418",
  "legislation_title": "The Medicines (Fees Relating to Medicinal Products for Human Use) Regulations 1989",
  "legislation_url": "https://openlegislation.uk/medicines-fees-relating-to-medicinal-products-for-human-use-regulations-1989",
  "path": "schedule/3/paragraph/2",
  "kind": "paragraph",
  "number": "2",
  "heading": null,
  "text": "(1) Subject to sub-paragraph (2) below, where an application for a product licence or a clinical trial certificate is withdrawn before determination by the licensing authority, the following percentage of the fee otherwise payable under regulation 3(a) or 4 of these Regulations in connection with that application shall be refunded or, if it has not yet been paid, shall be waived:—\n(a) if the application has been received but no medical, scientific or pharmaceutical assessment thereof has begun, 90%;\n(b) except in a case to which paragraph (c) below applies, if medical, scientific or pharmaceutical assessment has begun but not been completed, 50%;\n(c) if a request for further information in connection with the application has been made by the licensing authority under section 44(1) of the Medicines Act 1968, 25%.\n(2) If an application for a product licence or clinical trial certificate is withdrawn either after medical, scientific and pharmaceutical assessment has been completed or following consideration of that application by a committee established under section 4 of the Medicines Act 1968 or by the Medicines Commission, no refund or waiver of the fee payable under regulation 3(a) or 4 of these Regulations in connection with that application shall be made under this paragraph.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "amended",
      "affecting": "uksi/1990/210",
      "affecting_title": "The Medicines (Fees Relating to Medicinal Products for Human Use) Amendment Regulations 1990"
    },
    {
      "type": "amended",
      "affecting": "uksi/1990/2326",
      "affecting_title": "The Medicines (Fees Relating to Medicinal Products for Human Use) Amendment (No. 2) Regulations 1990"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1989/418/schedule/3/paragraph/2",
    "retrieved_at": "2026-10-29T15:47:51.296593+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."
}