{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-119",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-119.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/119",
  "kind": "paragraph",
  "number": "119",
  "heading": null,
  "text": "In regulation 152 (amendment of regulation 192 (obligation to submit periodic safety reports: derogation from general requirements))—\n(a) in paragraph (3), for “for “EMA” to the end substitute “after “EMA” insert “and the licensing authority or, in the case of a holder of a UKMA(GB), to the licensing authority only,”;\n(b) for paragraph (4) substitute—\n“(4) In paragraph (9), after “paragraph (3)(a)” insert “from the holder of a UKMA(UK), UKMA(NI), THR(UK), THR(NI) or Article 126a authorisation”.”.",
  "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/119",
    "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."
}