{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-89",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-89.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/89",
  "kind": "regulation",
  "number": "89",
  "heading": "Amendment of regulation 80 (urgent safety restrictions)",
  "text": "(1) Regulation 80 is amended as follows.\n(2) In the introductory words, insert “ UK ” before “marketing authorisation”.\n(3) For paragraph (a) substitute—\n“(a) fails—\n(i) in respect of a UKMA(GB) or UKMA(UK), to inform the licensing authority in accordance with paragraph 14(1) of Schedule 10A, or\n(ii) in respect of a UKMA(NI), UKMA(UK) or EU marketing authorisation, to inform the European Commission in accordance with Article 22(1) of Regulation (EC) No 1234/2008,\nthat the holder has taken urgent safety restrictions on the holder’s own initiative;”.\n(4) For paragraph (b) substitute—\n“(b) fails—\n(i) in respect of a UKMA(GB), to implement an urgent safety restriction imposed on the holder by the licensing authority in accordance with paragraph 14(3) of Schedule 10A, or\n(ii) in respect of a UKMA(NI) or UKMA(UK), to implement an urgent safety restriction imposed on the holder by the European Commission under Article 22(2) of Regulation (EC) No 1234/2008; or”.\n(4A) In paragraph (c) after “fails” insert “in respect of a UKMA(NI)”.\n(5) After paragraph (c) insert —\n“(d) fails in respect of a UKMA(GB) to submit an application for variation of the UK marketing authorisation to the licensing authority in accordance with paragraph 14(4) of Schedule 10A before the end of the period of fifteen days beginning with the day after—\n(i) the taking under paragraph 14(1) of Schedule 10A or, as the case may be,\n(ii) the imposition under paragraph 14(3) of that Schedule,\nof an urgent safety restriction.”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 89(3) 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. 66(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Reg. 89(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. 66(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 89(4A) 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. 66(c)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in reg. 89(5) 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. 66(d)(i)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Reg. 89(5): inserted para. (c) renumbered as para. (d) (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. 66(d)(ii)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Words in reg. 89(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. 66(d)(iii)"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 89 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/89",
    "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."
}