{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-40",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-40.json",
  "legislation": "uksi/2016/190",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2016",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016",
  "path": "schedule/2/paragraph/40",
  "kind": "paragraph",
  "number": "40",
  "heading": "Reclassification of marketing authorisations",
  "text": "(1) Where an application is a reclassification variation application to which this paragraph applies, the fee payable under regulation 19(1) in connection with the application for variation of a marketing authorisation is £1,593.\n(2) This paragraph applies to a reclassification variation application which would have the effect that a medicinal product to which the marketing authorisation relates—\n(a) is to be available only from a pharmacy (where previously it was available only on prescription), if an analogous medicinal product is available only from a pharmacy or on general sale; or\n(b) is to be available on general sale (where previously it was available only on prescription or only from a pharmacy), if an analogous medicinal product is available on general sale.\n(3) For the purposes of this paragraph, an analogous medicinal product is a medicinal product which has a United Kingdom marketing authorisation or a European Union marketing authorisation 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 variation application is made.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sum in Sch. 2 para. 40(1) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(15)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/40",
    "retrieved_at": "2026-10-28T23:27:13.215121+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."
}