{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-198",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-198.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/198",
  "kind": "regulation",
  "number": "198",
  "heading": "Post-authorisation safety studies: general provisions",
  "text": "(1) A relevant post-authorisation safety study—\n(a) may not be conducted where the act of conducting the study promotes the use of a medicinal product; and\n(b) may not provide for payments to health care professionals for participating in the study except in compensation for time and expenses incurred.\n(2) The licensing authority may require the holder for the product which is the subject of a relevant post-authorisation safety study to submit the protocol and progress reports for the study to\n(a) the competent authorities of the EEA States in which the study is conducted and the licensing authority, where the product is subject to a UKMA(UK)(Category 2), UKMA(UK)(NI), traditional herbal registration or Article 126a authorisation for sale or supply in Northern Ireland;\n(b) the licensing authority, where the product is subject to a UKMA(UK)(Category 1), a UKMA(GB) or traditional herbal registration for sale or supply in Great Britain only.\n(3) The holder for the product which is the subject of a relevant post-authorisation safety study must—\n(a) comply with a requirement imposed by the licensing authority under paragraph (2) (if any);\n(b) while the study is being conducted—\n(i) monitor the data generated, and\n(ii) consider its implications for the risk-benefit balance of the product which is the subject of the study;\n(c) communicate to\n(i) the relevant competent authorities and the licensing authority, where paragraph (2)(a) applies;\n(ii) the licensing authority where paragraph (2)(b) applies,\nany new information that arises at any point during the study which might influence the evaluation of the risk-benefit balance for that product as soon as is reasonably practicable after it becomes known to the holder; and\n(d) send the final report on the study to\n(i) the competent authorities of the EEA States in which the study was conducted and the licensing authority, where paragraph (2)(a) applies;\n(ii) the licensing authority, where paragraph (2)(b) applies,\nbefore the end of the period of 12 months beginning on the day after the day on which data collection for the study ended.\n(4) This regulation is subject to regulation 212 (transitional arrangements).",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 198(2) renumbered as reg. 198(2)(a) (31.12.2020) by S.I. 2019/775, reg. 158(2)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(a))"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 198(2)(a) inserted (31.12.2020) by S.I. 2019/775, reg. 158(2)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(a))"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 198(2)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 89(a)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Reg. 198(2)(b) inserted (31.12.2020) by S.I. 2019/775, reg. 158(2)(c) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(a))"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in reg. 198(2)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 89(b)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Reg. 198(3)(c)(i)(ii) substituted for words in reg. 198(3)(c) (31.12.2020) by S.I. 2019/775, reg. 158(3)(a)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(i))"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Words in reg. 198(3)(c) become full-out words (31.12.2020) by S.I. 2019/775, reg. 158(3)(a)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(i))"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Words in reg. 198(3)(d) renumbered as reg. 198(3)(d)(i) (31.12.2020) by S.I. 2019/775, reg. 158(3)(b)(i) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(ii))"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Words in reg. 198(3)(d)(i) inserted (31.12.2020) by S.I. 2019/775, reg. 158(3)(b)(ii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(ii))"
    },
    {
      "type": "F",
      "label": "F10",
      "text": "Reg. 198(3)(d)(ii) inserted (31.12.2020) by S.I. 2019/775, reg. 158(3)(b)(iii) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(ii))"
    },
    {
      "type": "F",
      "label": "F11",
      "text": "Words in reg. 198(3)(d) become full-out words (31.12.2020) by S.I. 2019/775, reg. 158(3)(b)(iv) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(ii))"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/198",
    "retrieved_at": "2026-10-29T01:24:34.993203+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."
}