{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-2",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-2.json",
  "legislation": "uksi/2008/552",
  "legislation_title": "The Medicines (Products for Human Use-Fees) Regulations 2008",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008",
  "path": "schedule/1/paragraph/2",
  "kind": "paragraph",
  "number": "2",
  "heading": "Marketing authorizations",
  "text": "(1) Unless paragraphs 3, 4, 6 or 7 apply, the fee payable under regulation 12(1)(a) in connection with an application for a marketing authorization of a kind described in column 1 of the following table is—\n(a) if the application is an eCTD format application, the fee specified in the corresponding entry in column 2 of that table; or\n(b) if the application is not an eCTD format application, the fee specified in the corresponding entry in column 3 of that table.\nFees for marketing authorization applications\nColumn 1\nKind of application\nColumn 2\nFee payable if application is in eCTD format\nColumn 3\nFee payable if application is not in eCTD format\n1. Major application\n(a)\nin respect of an application relating to an orphan medicinal product to which point 6 of Part 2 of Annex 1 to the 2001 Directive applies\n£30,101\n£31,576\n(b)\nwhich is a mutual recognition procedure incoming application\n£63,198\n£66,295\n(c)\nwhich is a European reference product application\n£63,198\n£66,295\n(d)\nwhich is a decentralised procedure application where the United Kingdom is a concerned member State\n£90,671\n£95,114\n(e)\nwhich is a decentralised procedure application where the United Kingdom is a reference Member State\n£138,145\n£144,914\n(f)\nin any other case\n£93,907\n£98,491\n2. Complex application\n(a)\nwhich is a mutual recognition procedure incoming application\n£17,546\n£18,406\n(b)\nwhich is a European reference product application\n£17,546\n£18,406\n(c)\nwhich is a decentralised procedure application where the United Kingdom is a concerned member State\n£25,068\n£26,296\n(d)\nwhich is a decentralised procedure application where the United Kingdom is a reference Member State\n£40,461\n£42,444\n(e)\nin any other case\n£25,962\n£27,228\n3. Standard application\n(a)\nwhich is a mutual recognition procedure incoming application\n£6,430\n£6,745\n(b)\nwhich is a European reference product application\n£6,430\n£6,745\n(c)\nwhich is a decentralised procedure application where the United Kingdom is a concerned member State\n£9,191\n£9,642\n(d)\nwhich is a decentralised procedure application where the United Kingdom is a reference Member State\n£17,779\n£18,650\n(e)\nin any other case\n£9,519\n£9,984\n4. Simple application\n(a)\nwhich is a decentralised procedure application where the United Kingdom is a concerned member State\n£2,596\n£2,722\n(b)\nin any other case\n£2,596\n£2,722\n5. Application for a parallel import licence\nNot applicable\n£1,815\n6. Change of ownership application\nNot applicable\n£448\n(2) Each reference in paragraphs 3, 5 and 6 to an amount payable under paragraph 2 in respect of an application refers to the amount payable under that paragraph in respect of an application of the kind in question.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2008/552/schedule/1/paragraph/2",
    "retrieved_at": "2026-10-29T03:35:25.906399+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."
}