{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-66",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-66.json",
  "legislation": "ukdsi/2020/9780348213980",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020",
  "legislation_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020",
  "path": "schedule/2/paragraph/66",
  "kind": "paragraph",
  "number": "66",
  "heading": null,
  "text": "In regulation 89 (amendment of regulation 80 (urgent safety restrictions))—\n(a) for paragraph (3) substitute—\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(b) for paragraph (4) substitute—\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(c) after paragraph (4) insert—\n“(4A) In paragraph (c) after “fails” insert “in respect of a UKMA(NI)”.”;\n(d) in paragraph (5)—\n(i) for “For sub-paragraph (c) substitute” substitute “After paragraph (c) insert”;\n(ii) renumber the paragraph inserted as sub-paragraph (d);\n(iii) in the paragraph inserted, after “fails” insert “in respect of a UKMA(GB)”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/66",
    "retrieved_at": "2026-10-30T14:48:26.477695+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."
}