{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-80",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-80.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/80",
  "kind": "paragraph",
  "number": "80",
  "heading": null,
  "text": "In regulation 102 (amendment of regulation 110 (revocation, variation and suspension of certificate of registration))—\n(a) for paragraph (2) substitute—\n“(2) In paragraph (7) for “established in the European Union” substitute—\n“established in—\n(a) the United Kingdom; or\n(b) in relation to a COR(NI), either the United Kingdom or the European Union,\nin accordance with the requirements of these Regulations.”.”;\n(b) after paragraph (2) insert—\n“(2A) After paragraph (8A) insert—\n“(8B) Condition I is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.”.”.",
  "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/80",
    "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."
}