{
  "url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-55",
  "json_url": "https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-55.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/55",
  "kind": "paragraph",
  "number": "55",
  "heading": null,
  "text": "In regulation 74 (amendment of regulation 66 (application for renewal of authorisation)) for “66(2)” to the end substitute—\n“66, for paragraph (2) substitute—\n“(2) The applicant, where it is applying for renewal of—\n(a) a UKMA(NI)—\n(i) in accordance with Chapter 4 of Title III of the 2001 Directive, must be established in the European Union;\n(ii) on any other basis, must be established in the United Kingdom;\n(b) a UKMA(GB)—\n(i) under the unfettered access route, must be established in Northern Ireland;\n(ii) other than under the unfettered access route, must be established in the United Kingdom;\n(c) a UKMA(UK), must be established in the United Kingdom.”.”;",
  "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/55",
    "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."
}