{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-44",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/schedule-2/paragraph-44.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/2/paragraph/44",
  "kind": "paragraph",
  "number": "44",
  "heading": "Variation of manufacturer's authorisations and licences",
  "text": "The fee payable under regulation 19(1) in connection with an application for variation of a manufacturing authorisation or a manufacturer's licence is £345 in respect of each variation applied for which constitutes a change to the authorisation or licence not requiring an inspection or medical, scientific or pharmaceutical assessment.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sum in Sch. 2 para. 44 substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 27(19)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/schedule/2/paragraph/44",
    "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."
}