{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19E",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19E.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": "regulation/19E",
  "kind": "regulation",
  "number": "19E",
  "heading": "Fee for assessment of periodic safety update reports",
  "text": "(1) This regulation applies where—\n(a) a periodic safety update report has been submitted to the licensing authority under regulation 191 or 192 of the Human Medicines Regulations; and\n(b) that periodic safety update report relates to a medicinal product which has a UK reference date within the meaning of regulation 193 of the Human Medicines Regulations.\n(2) Where this regulation applies, the fee payable by the holder of a marketing authorisation or traditional herbal registration to which the periodic safety update report relates is—\n(a) £1,066, in the case where no other periodic safety update reports relating to medicinal products with the same UK reference date are submitted; and\n(b) £534, in any other case.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 19A-19G inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 1 para. 2 (with Sch. 1 para. 11) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 188(c)(i)(aa)(bb)); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Sum in reg. 19E(2)(a) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 18(a)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Sum in reg. 19E(2)(b) substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 18(b)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/regulation/19E",
    "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."
}