{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-25",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-25.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": "regulation/25",
  "kind": "regulation",
  "number": "25",
  "heading": "Fees for assessment of a set of proposed changes to labels and leaflets",
  "text": "(1) Unless paragraph (2) applies, where—\n(a) a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a United Kingdom marketing authorisation (other than a parallel import licence) is submitted to the licensing authority in accordance with Article 61(3) of the 2001 Directive; or\n(b) a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a parallel import licence is submitted to the licensing authority,\nthe fee payable by the holder of that authorisation or licence is the fee prescribed in Part 5 of Schedule 2 in connection with that change.\n(2) Paragraph (1) does not apply where a change to the labelling or package leaflet of a medicinal product is proposed in connection with an application for the variation of the marketing authorisation for that product.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/regulation/25",
    "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."
}