{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-175",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-175.json",
  "legislation": "uksi/2019/775",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/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, after “the Implementing Regulation insert “and Schedule 12A”.\n(3) In paragraph (1)—\n(a) in sub-paragraph (a), at the beginning insert “in relation to a UKMA(NI), UKMA(UK), THR(NI) THR(UK) or Article 126a authorisation,”;\n(b) after sub-paragraph (a) insert—\n“(aa) in relation to a UKMA(GB) or THR(GB), fails to comply with any requirement or obligation contained in a provision of Schedule 12A listed in paragraph (2A); or”.\n(4) After paragraph (2) insert—\n“(2A) 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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .”.\n(5) In paragraph (4), after “Implementing Regulation” insert “, or of paragraph 26(8) or 29(1) of Schedule 12A,”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Word in reg. 175(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(a)(i)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 175(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(a)(ii)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 175(3)(a)(b) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(b)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in reg. 175(4) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(c)(i)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Words in reg. 175(4) renumbered (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(c)(ii)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Words in reg. 175(4) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(c)(iii)"
    },
    {
      "type": "F",
      "label": "F7",
      "text": "Reg. 175(5) inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 137(d)"
    },
    {
      "type": "M",
      "label": "M1",
      "text": "Regulation 210A was inserted by S.I. 2013/1855."
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 175 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2019/775/regulation/175",
    "retrieved_at": "2026-10-28T22:42:14.621781+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."
}