{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-7",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-7.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/4/paragraph/7",
  "kind": "paragraph",
  "number": "7",
  "heading": "Marketing authorisation: derivatives",
  "text": "Unless paragraph 8 applies, where a marketing authorisation is held in respect of a derivative of a new active substance, the fee payable under regulation 38(1) is—\n(a) £11,627 where the medicinal product to which the authorisation relates has a different route of administration from that of the new active substance; or\n(b) £7,847 in any other case.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sum in Sch. 4 para. 7(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(4)(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sum in Sch. 4 para. 7(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(4)(b)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/schedule/4/paragraph/7",
    "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."
}