{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-3/paragraph-6",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-3/paragraph-6.json",
  "legislation": "uksi/1995/1116",
  "legislation_title": "The Medicines (Products for Human Use — Fees) Regulations 1995",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995",
  "path": "schedule/3/paragraph/6",
  "kind": "paragraph",
  "number": "6",
  "heading": "Marketing authorizations",
  "text": "Where a reduced rate fee or a maintenance fee may be payable in respect of any relevant fee period and an authorization holder does not submit evidence of turnover in relation to the relevant calendar year to the satisfaction of the licensing authority, the periodic fee payable by him shall, where applicable, be the standard fee for each description of medicinal product in respect of which a marketing authorization is held by the authorization holder.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "am",
      "affecting": "uksi/2003/2321",
      "affecting_title": "The Medicines for Human Use (Fees and Miscellaneous Amendments) Regulations 2003"
    },
    {
      "type": "words inserted",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000"
    },
    {
      "type": "substituted",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000"
    },
    {
      "type": "sums substituted",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000"
    },
    {
      "type": "sums substituted",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000"
    },
    {
      "type": "sums substituted",
      "affecting": "uksi/2000/592",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2000"
    },
    {
      "type": "am",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001"
    },
    {
      "type": "am",
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      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001"
    },
    {
      "type": "am",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001"
    },
    {
      "type": "am",
      "affecting": "uksi/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001"
    },
    {
      "type": "am",
      "affecting": "uksi/2006/2125",
      "affecting_title": "The Medicines for Human Use (Fees Amendments) Regulations 2006"
    },
    {
      "type": "amended",
      "affecting": "uksi/1999/566",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1999"
    },
    {
      "type": "am",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003"
    },
    {
      "type": "am",
      "affecting": "uksi/2003/625",
      "affecting_title": "The Medicines for Human Use and Medical Devices(Fees Amendments) Regulations 2003"
    },
    {
      "type": "words inserted",
      "affecting": "uksi/2004/1157",
      "affecting_title": "The Medicines for Human Use (Clinical Trials Fees Amendments) Regulations 2004"
    },
    {
      "type": "rev in pt",
      "affecting": "uksi/2005/2979",
      "affecting_title": "The Medicines for Human Use (Fees Amendments)(No. 2) Regulations 2005"
    },
    {
      "type": "subst",
      "affecting": "uksi/2005/2979",
      "affecting_title": "The Medicines for Human Use (Fees Amendments)(No. 2) Regulations 2005"
    },
    {
      "type": "added",
      "affecting": "uksi/2005/2979",
      "affecting_title": "The Medicines for Human Use (Fees Amendments)(No. 2) Regulations 2005"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "am",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002"
    },
    {
      "type": "am",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002"
    },
    {
      "type": "am",
      "affecting": "uksi/2002/542",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2002"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1995/1116/schedule/3/paragraph/6",
    "retrieved_at": "2026-10-29T13:10:38.932521+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."
}