{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-46",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012/schedule-2/paragraph-46.json",
  "legislation": "nisr/2012/134",
  "legislation_title": "The Medicines (Products for Human Use) (Fees) Regulations 2012",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2012",
  "path": "schedule/2/paragraph/46",
  "kind": "paragraph",
  "number": "46",
  "heading": "Identical variations",
  "text": "(1) Unless paragraph 47 or 48 applies, where more than one application—\n(a) of a type referred to in sub-paragraph (2) is made at the same time by the same marketing authorization holder and all of the applications are for identical kinds of variations; or\n(b) by the same applicant is made at the same time for a traditional herbal registration, a manufacturer’s licence, or a wholesale dealer’s licence and where the applications are for identical variations,\nthe fee payable under regulation 18(1) is that specified in sub-paragraph (3).\n(2) The type of application referred to in sub-paragraph (1) is a—\n(a) Type IB Application;\n(b) Type II Application;\n(c) Minor Variation (Type IB) Group Application; or\n(d) Major Variation (Type II) Group Application.\n(3) The fee referred to in sub-paragraph (1)—\n(a) in connection with the first application considered by the licensing authority is the appropriate amount specified in this Part of this Schedule; and\n(b) in connection with each of the other applications is 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/nisr/2012/134/schedule/2/paragraph/46",
    "retrieved_at": "2026-10-29T01:16:38.443269+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."
}