{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-3/part-III/paragraph-3",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-1995/schedule-3/part-III/paragraph-3.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/III/paragraph/3",
  "kind": "paragraph",
  "number": "3",
  "heading": "Marketing authorizations",
  "text": "Subject to paragraph 4, where a marketing authorization is held in respect of a derivative of a new active substance, the fee payable under regulation 14(3) shall be—\n(a) where it is of the same dosage form as, but of a different strength of active ingredient or different combination of active ingredients from, that relating to the new active substance, £3,575;\n(b) where it is of a different dosage form from that relating to the new active substance, £5,950.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [
    {
      "type": "word substituted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "sum substituted",
      "affecting": "uksi/2004/666",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004"
    },
    {
      "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": "amended",
      "affecting": "uksi/1996/683",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1996"
    },
    {
      "type": "substituted",
      "affecting": "uksi/1996/683",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1996"
    },
    {
      "type": "revoked",
      "affecting": "uksi/1996/683",
      "affecting_title": "The Medicines (Products for Human Use—Fees) Amendment Regulations 1996"
    },
    {
      "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": "rev. in pt.",
      "affecting": "uksi/1998/574",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998"
    },
    {
      "type": "amended",
      "affecting": "uksi/1998/574",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees and Miscellaneous Amendments) Regulations 1998"
    },
    {
      "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": "inserted",
      "affecting": "uksi/2004/1157",
      "affecting_title": "The Medicines for Human Use (Clinical Trials Fees Amendments) Regulations 2004"
    },
    {
      "type": "sum substituted",
      "affecting": "uksi/2004/666",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004"
    },
    {
      "type": "sum substituted",
      "affecting": "uksi/2004/666",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004"
    },
    {
      "type": "sum substituted",
      "affecting": "uksi/2004/666",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004"
    },
    {
      "type": "sum substituted",
      "affecting": "uksi/2004/666",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004"
    },
    {
      "type": "sum substituted",
      "affecting": "uksi/2004/666",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004"
    },
    {
      "type": "sum substituted",
      "affecting": "uksi/2004/666",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004"
    },
    {
      "type": "sum substituted",
      "affecting": "uksi/2004/666",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2004"
    },
    {
      "type": "sum substituted",
      "affecting": "uksi/2004/666",
      "affecting_title": "The Medicines for Human Use and Medical Devices (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 inserted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "words inserted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/803",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007"
    },
    {
      "type": "words inserted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "words inserted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "inserted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "type": "word substituted",
      "affecting": "uksi/2007/610",
      "affecting_title": "The Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2007"
    },
    {
      "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/III/paragraph/3",
    "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."
}