{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-201",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-201.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/201",
  "kind": "regulation",
  "number": "201",
  "heading": "Submission and evaluation of final study reports for required studies",
  "text": "(1) This regulation applies where a study to which regulation 199 applies has been completed.\n(2) Subject to paragraph (4), the holder for the product which is the subject of the study must submit electronically, before the end of the period of 12 months beginning on the day after the day on which data collection for the study ended, to—\n(a) the body specified in paragraph (3) and the licensing authority (where not otherwise required by paragraph (3)), where the authorisation for the product is a UKMA(NI) or UKMA(UK)(Category 2);\n(b) the licensing authority, where the authorisation for the product is a UKMA(GB) or UKMA(UK)(Category 1),\na final study report and an abstract of the study results.\n(3) The body specified in this paragraph is—\n(a) where the study was conducted in the United Kingdom only, the licensing authority; or\n(b) where the study was conducted in the EU or an EEA State, the Pharmacovigilance Risk Assessment Committee.\n(4) Paragraph (2) does not apply where a written waiver has been granted by the licensing authority ..., or by the Pharmacovigilance Risk Assessment Committee ....\n(5) The holder must without delay—\n(a) evaluate whether the results of a final study report submitted under paragraph (2) have an impact on the authorisation or registration of the medicinal product to which the report relates; and\n(b) if necessary, submit an application to vary the authorisation or registration for the product.\n(6) This regulation is subject to regulation 212 (transitional arrangements).",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 201(2)(a)(b) substituted for words in reg. 201(2) (31.12.2020) by S.I. 2019/775, reg. 161(2) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 129(a))"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 201(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), 92(a)(i)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 201(2)(b) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 92(a)(ii)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in reg. 201(3)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 92(b)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in reg. 201(4) omitted (31.12.2020) by S.I. 2019/775, reg. 161(4) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 129(c)); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/201",
    "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."
}