{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-210A",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-210A.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/210A",
  "kind": "regulation",
  "number": "210A",
  "heading": "Offences in relation to pharmacovigilance obligations under the Implementing Regulation and Schedule 12A",
  "text": "(1) A holder is guilty of an offence if the holder—\n(a) in relation to a UKMA(NI), UKMA(UK)(Category 2), THR(NI) THR(UK) or Article 126a authorisation, fails to comply with any requirement or obligation contained in a provision of the Implementing Regulation listed in paragraph (2); or\n(aa) in relation to a UKMA(GB) , UKMA(UK)(Category 2) or THR(GB), fails to comply with any requirement or obligation contained in a provision of Schedule 12A listed in paragraph (2A); or\n(b) provides information which is false or misleading in a material particular to the licensing authority or the EMA pursuant to an obligation in the Implementing Regulation.\n(2) The provisions mentioned in paragraph (1)(a) are—\n(a) Chapter I (pharmacovigilance system master file);\n(b) Sections 1 and 2 of Chapter II (minimum requirements for the quality systems for the performance of pharmacovigilance activities);\n(c) Chapter III (minimum requirements for the monitoring of data in the Eudravigilance database);\n(d) Chapter V (transmission of reports of suspected adverse reactions);\n(e) Article 32 of Chapter VI (updates of risk management plans);\n(f) Chapter VII (periodic safety update reports); and\n(g) Chapter VIII (post-authorisation safety studies).\n(2A) The provisions of Schedule 12A mentioned in paragraph (1)(aa) are—\n(a) Part 1 (pharmacovigilance system master file);\n(b) Parts 2 and 3 (minimum requirements for the quality systems in the performance of pharmacovigilance activities);\n(c) Part 6 (transmission of reports of suspected adverse reactions);\n(d) paragraph 24 (update of risk management plans);\n(e) Part 8 (periodic safety update reports); and\n(f) Part 9 (post-authorisation safety studies).\n(3) Subject to paragraph (4), a person guilty of an offence under this regulation is liable—\n(a) on summary conviction to a fine not exceeding the statutory maximum; or\n(b) on conviction on indictment to a fine.\n(4) A person guilty of an offence under this regulation which relates to a breach of Article 34(5) or 36(3) of the Implementing Regulation , or of paragraph 26(8) or 29(1) of Schedule 12A, is liable—\n(a) on summary conviction to a fine not exceeding the statutory maximum; or\n(b) on conviction on indictment to a fine, to imprisonment for a term not exceeding two years or to both.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 210A inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 25"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 210A(1)(a) inserted (31.12.2020) by S.I. 2019/775, reg. 175(3)(a) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(b))"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 210A(1)(a) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 99(a)(i)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Reg. 210A(1)(aa) inserted (31.12.2020) by S.I. 2019/775, reg. 175(3)(b) (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(b))"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in reg. 210A(1)(aa) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 99(a)(ii)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Reg. 210A(2A) inserted (31.12.2020) by S.I. 2019/775, reg. 175(4) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(c))"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Word in reg. 210A(2A) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 99(b)"
    },
    {
      "type": "F",
      "label": "F8",
      "text": "Words in reg. 210A(4) inserted (31.12.2020) by S.I. 2019/775, reg. 175(5) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(d))"
    },
    {
      "type": "F",
      "label": "F9",
      "text": "Words in reg. 210A heading inserted (31.12.2020) by S.I. 2019/775, reg. 175(2) (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(a))"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/210A",
    "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."
}