{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-24",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-24.json",
  "legislation": "nisr/2012/134",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2012",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012",
  "path": "schedule/2/paragraph/24",
  "kind": "paragraph",
  "number": "24",
  "heading": "Marketing authorizations",
  "text": "(1) Unless paragraphs 25, 26, 28 or 29 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 the fee specified in the corresponding entry in column 2 of that table.\nFees for marketing authorization applications\nColumn 1\nKind of application\nColumn 2\nFee payable\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£32,135\n(b)\nwhich is a mutual recognition procedure incoming application\n£67,468\n(c)\nwhich is a European reference product application\n£67,468\n(d)\nwhich is a decentralised procedure application where the United Kingdom is a concerned Member State\n£96,797\n(e)\nwhich is a decentralised procedure application where the United Kingdom is a reference Member State\n£139,235\n(f)\nin any other case\n£100,252\n2. Complex application\n(a)\nwhich is a mutual recognition procedure incoming application\n£18,732\n(b)\nwhich is a European reference product application\n£18,732\n(c)\nwhich is a decentralised procedure application where the United Kingdom is a concerned Member State\n£26,762\n(d)\nwhich is a decentralised procedure application where the United Kingdom is a reference Member State\n£40,780\n(e)\nin any other case\n£27,716\n3. Standard application\n(a)\nwhich is a mutual recognition procedure incoming application\n£6,864\n(b)\nwhich is a European reference product application\n£6,864\n(c)\nwhich is a decentralised procedure application where the United Kingdom is a concerned Member State\n£9,812\n(d)\nwhich is a decentralised procedure application where the United Kingdom is a reference Member State\n£17,920\n(e)\nin any other case\n£10,162\n4. Simple application\n(a)\nwhich is a decentralised procedure application where the United Kingdom is a concerned Member State\n£2,771\n(b)\nwhich is a decentralised procedure application where the United Kingdom is a reference Member State\n£9,275\n(c)\nin any other case\n£2,771\n5. Parallel import licence applications\n(a)\nin respect of a simple parallel import licence\n£1,937\n(b)\nin respect of a standard parallel import licence\n£7,201\n(c)\nin respect of a complex parallel import licence\n£19,650\n6. Change of ownership application\n£478\n(2) Each reference in paragraphs 25, 27 and 28 to an amount payable under paragraph 24 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/nisr/2012/134/schedule/2/paragraph/24",
    "retrieved_at": "2026-10-29T01:16:38.443269+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."
}