{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-30",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-30.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/30",
  "kind": "paragraph",
  "number": "30",
  "heading": "Single set of changes",
  "text": "(1) Unless paragraph 31 applies, the fee payable under regulation 22(1) in connection with a set of proposed changes to the labelling or the package leaflet of a medicinal product is —\n(a) £524, in respect of a product which is the subject of a United Kingdom marketing authorization other than a parallel import licence; and\n(b) £332, in respect of a product which is the subject of a parallel import licence.\n(2) But if the proposed changes in respect of a product to which the fee in sub-paragraph (a) applies are submitted in accordance with the BROMI labels and leaflets self – certification procedure the fee payable under regulation 22(1) is £188.\n(3) For the purpose of this paragraph changes are submitted in accordance with the BROMI self -certification procedure if they are of a type described in the BROMI labels and leaflets self-certification guidance and comply with the conditions set out in relation to those changes in that guidance.",
  "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/30",
    "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."
}