{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-3",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-3.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/3",
  "kind": "paragraph",
  "number": "3",
  "heading": "Fees where application includes reclassification",
  "text": "(1) Unless paragraph 5 applies, where an application, other than a major application, includes a reclassification element, an amount of –\n(a) £8,264 if the application is an eCTD format application; or\n(b) £8,666, if the application is not an eCTD format application,\nis payable in addition to the amount payable under paragraph 2 in respect of that application.\n(2) For the purposes of this paragraph and paragraph 6, an application includes a reclassification element if—\n(a) the medicinal product in question is to be available in the United Kingdom only from a pharmacy, unless there is an analogous medicinal product available in the United Kingdom only from a pharmacy or on general sale; or\n(b) the medicinal product in question is to be available in the United Kingdom on general sale, unless there is an analogous medicinal product also so available.\n(3) For the purposes of this paragraph, an analogous medicinal product is a medicinal product which has a United Kingdom marketing authorization or a Community marketing authorization and which—\n(a) has the same active ingredient, route of administration and use;\n(b) has the same strength or a higher strength;\n(c) has the same dosage or daily dosage, or a higher dosage or daily dosage; and\n(d) is for sale or supply at the same quantity or a greater quantity,\nas the medicinal product in relation to which the application is made.",
  "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/3",
    "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."
}