{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-74",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-74.json",
  "legislation": "uksi/2019/775",
  "legislation_title": "The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019",
  "legislation_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019",
  "path": "regulation/74",
  "kind": "regulation",
  "number": "74",
  "heading": "Amendment of regulation 66 (application for renewal of authorisation)",
  "text": "In regulation 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": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 74 substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 55"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 74 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2019/775/regulation/74",
    "retrieved_at": "2026-10-28T22:42:14.621781+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."
}