{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-31",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-31.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/31",
  "kind": "paragraph",
  "number": "31",
  "heading": "More than one set of charges purposed",
  "text": "(1) This paragraph applies where more than one set of proposed changes falling within regulation 22(1) is submitted by the same marketing authorization holder at the same time and where—\n(a) the sets of proposed changes consist of identical changes to the labelling or package leaflets of products with the same active ingredient or combination of ingredients, dosage form and clinical particulars; or\n(b) the sets of proposed changes consist of identical changes to different versions of the labelling or package leaflet of the same product.\n(2) Where this paragraph applies, the fee payable under regulation 22(1) is —\n(a) in connection with the first set of proposed changes considered by the licensing authority, the appropriate amount specified in paragraph 30; and\n(b) in connection with each of the other sets of proposed changes, 50 per cent of that amount.",
  "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/31",
    "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."
}