{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-3/part-II/paragraph-1",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-3/part-II/paragraph-1.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/part/II/paragraph/1",
  "kind": "paragraph",
  "number": "1",
  "heading": null,
  "text": "(1) Subject to sub-paragraph (2), “turnover” means, for the purposes of calculating the periodic fee payable in connection with the holding of a marketing authorization for a relevant fee period, the gross value at manufacturer’s prices of all medicinal products to which the authorization relates which are sold or supplied in the United Kingdom by the holder of the authorization during the year which ends on the 31st December preceding the beginning of that fee period.\n(2) For the purposes of calculating the periodic fee payable in connection with the holding of marketing authorizations mentioned in Part IV of this Schedule for a relevant fee period, the quantity of products taken for the purposes of sub-paragraph (1) is the aggregate of all the products to which the authorizations relate.",
  "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",
      "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/2001/795",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 2001"
    },
    {
      "type": "amended",
      "affecting": "uksi/1998/574",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998"
    },
    {
      "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/part/II/paragraph/1",
    "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."
}