{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-55",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-55.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/55",
  "kind": "paragraph",
  "number": "55",
  "heading": "More than one set of changes proposed",
  "text": "(1) In this paragraph, “clinical particulars” means the clinical particulars contained in the Summary of Product Characteristics for that product as specified in of Article 11 of the 2001 Directive.\n(2) This paragraph applies where more than one set of proposed changes falling within regulation 25(1) is submitted by the same marketing authorisation 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(3) Where this paragraph applies, the fee payable under regulation 25(1) is—\n(a) in connection with the first set of proposed changes considered by the licensing authority, the appropriate amount specified in paragraph 54; and\n(b) in connection with each of the other sets of proposed changes, 50% 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/2016/190/schedule/2/paragraph/55",
    "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."
}