{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-113",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-113.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/113",
  "kind": "paragraph",
  "number": "113",
  "heading": null,
  "text": "For regulation 145 (amendment of regulation 186 (reporting obligations on the licensing authority)) substitute—\n“145. In regulation 186—\n(a) in paragraph (1), for sub-paragraphs (d) and (e) substitute—\n“(d) submit reports of serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—\n(i) a UKMA(NI),\n(ii) a UKMA(UK),\n(iii) a THR(NI),\n(iv) a THR(UK), or\n(v) an Article 126a authorisation,\nto the EMA before the end of the period of 15 days beginning on the day following the day on which the report was received; and\n(e) submit reports of non-serious suspected adverse reactions in Northern Ireland that it has recorded under regulation 185 in relation to—\n(i) a UKMA(NI),\n(ii) a UKMA(UK),\n(iii) a THR(NI),\n(iv) a THR(UK), or\n(v) an Article 126a authorisation,\nto the EMA before the end of the period of 90 days beginning on the day following the day on which the report was received.”;\n(b) omit paragraph (4).”.",
  "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/113",
    "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."
}