{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19C",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2016/regulation-19C.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/19C",
  "kind": "regulation",
  "number": "19C",
  "heading": "Fees for assessment of post-authorisation safety studies",
  "text": "(1) This regulation applies to post-authorisation safety studies initiated, managed or financed by the holder of a marketing authorisation in compliance with obligations imposed under regulation 59 or 61 of the Human Medicines Regulations.\n(2) The fee payable by the holder of a marketing authorisation upon submission of the draft protocol for a post-authorisation safety study in accordance with regulation 199(2) of the Human Medicines Regulations—\n(a) where the authorisation for the medicinal product concerned is a UKMA(GB) granted under the unfettered access route or a UKMA(GB) granted where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding draft protocol has been submitted in respect of the related European Union marketing authorisation or UKMA(NI) for the same product, is £1,308;\n(b) where sub-paragraph (a) does not apply and—\n(i) the study is to be conducted in the United Kingdom only; or\n(ii) the authorisation for the product which is the subject of the study authorises sale or supply in Great Britain only,\nis £9,949; and\n(c) in any other case, is £1,308.\n( 3) The fee payable by the holder of a marketing authorisation upon submission of the final study report for a post-authorisation safety study in accordance with regulation 201(2) of the Human Medicines Regulations—\n(a) where the authorisation for the medicinal product concerned is a UKMA(GB) granted under the unfettered access route or a UKMA(GB) granted where the medicinal product concerned has already been granted a European Union marketing authorisation under Regulation (EC) No 726/2004 (an automatic recognition application), and provided a corresponding final study report has been submitted in respect of the related European Union marketing authorisation or UKMA(NI) for the same product, is £1,308;\n(b) where sub-paragraph (a) does not apply and—\n(i) the study is to be conducted in the United Kingdom only; or\n(ii) the authorisation for the product which is the subject of the study authorises sale or supply in Great Britain only,\nis £9,949; and\n(c) in any other case, is £1,308.",
  "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. 19C(2)(a) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 15(a)(i)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Sum in reg. 19C substituted (1.4.2025) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2025 (S.I. 2025/317), regs. 1(2), 17"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Sum in reg. 19C(2)(c) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 15(a)(iii)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Sum in reg. 19C(3)(a) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 15(b)(i)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Sum in reg. 19C(3)(c) substituted (1.4.2023) by The Medicines (Products for Human Use) (Fees) (Amendment) Regulations 2023 (S.I. 2023/314), regs. 1(2), 15(b)(iii)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2016/190/regulation/19C",
    "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."
}