{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-6",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-4/paragraph-6.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/6",
  "kind": "paragraph",
  "number": "6",
  "heading": "Marketing authorisation: where Part 2 of the Act applies",
  "text": "In the case of an article or substance to which Part 2 of the Act applies by virtue of the Medicines (Surgical Materials) Order 1971 , the fee payable under regulation 38(1) in connection with the holding of a marketing authorisation or licence is £368.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sum in Sch. 4 para. 6 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 29(3)"
    },
    {
      "type": "M",
      "label": "M1",
      "text": "S.I. 1971/1267: Part 2 of the Act is applied by article 3 of the Order which has been amended by S.I. 1994/3119, 2004/1031 and 2006/2407."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/schedule/4/paragraph/6",
    "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."
}