{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-57",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-57.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/57",
  "kind": "paragraph",
  "number": "57",
  "heading": null,
  "text": "In regulation 77 (amendment of regulation 68 (revocation, variation and suspension of UK marketing authorisation or parallel import licence))—\n(a) in paragraph (3), for sub-paragraph (b) substitute—\n“(b) for “established in the European Union” substitute—\n“established in—\n(a) the United Kingdom; or\n(b) in relation to a UKMA(NI), either the United Kingdom or the European Union,\nin accordance with the requirements of these Regulations.”.”;\n(b) for paragraph (5) substitute—\n“(5) In paragraph (9)(a) omit “other than the United Kingdom”.”;\n(c) in paragraph (8)—\n(i) in the inserted paragraph (11E), for “exit day” in both places it occurs substitute “IP completion day”;\n(ii) after the inserted paragraph (11F), insert—\n“(11G) Condition P 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/57",
    "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."
}