{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-175",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-175.json",
  "legislation": "ukdsi/2019/9780111179185",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019",
  "path": "regulation/175",
  "kind": "regulation",
  "number": "175",
  "heading": "Amendment of regulation 210A (offences in relation to pharmacovigilance obligations under the Implementing Regulation)",
  "text": "(1) Regulation 210A is amended as follows.\n(2) In the heading, for “the Implementing Regulation” substitute “Schedule 12A”.\n(3) In paragraph (1)—\n(a) in sub-paragraph (a) for “the Implementing Regulation” substitute “Schedule 12A”; and\n(b) in sub-paragraph (b)—\n(i) for “the Implementing Regulation” substitute “Schedule 12A”, and\n(ii) omit “or the EMA”.\n(4) For paragraph (2) substitute—\n“(2) The provisions of Schedule 12A mentioned in paragraph (1)(a) 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 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": "footnote",
      "label": "f1",
      "text": "Regulation 210A was inserted by S.I. 2013/1855."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2019/9780111179185/regulation/175",
    "retrieved_at": "2026-10-30T15:01:32.040145+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."
}