{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-45",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-45.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/45",
  "kind": "regulation",
  "number": "45",
  "heading": "Amendment of regulation 46 (requirement for authorisation)",
  "text": "(1) Regulation 46 is amended as follows.\n(2) In paragraph (2)—\n(a) in sub-paragraph (a), before “marketing authorisation”, insert “ UK ”;\n(b) after sub-paragraph (a) insert—\n“(aa) an EU marketing authorisation;”.\n(3) In paragraph (3), before “European Economic Area” insert “ United Kingdom or the ”.\n(4) In paragraph (6)—\n(a) after “in force for the product” insert “in the country in which the product is intended to be sold or supplied, or offered for sale or supply”;\n(b) in sub-paragraph (a), before “marketing authorisation”, insert “UK”; and\n(c) after sub-paragraph (a) insert—\n“(aa) an EU marketing authorisation;”.\n(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .\n(6) In paragraph (9), before “European Economic Area” insert “ United Kingdom or the ”.\n(7) In paragraph (11)(a), before “European Economic Area” insert “ United Kingdom or the ”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 45(2)(b) substituted for reg. 45(2)(b)(c) (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. 33(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Reg. 45(4)(a)-(c) 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. 33(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 45(5) omitted (31.12.2020 immediately before IP completion day) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 33(c)"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 45 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/45",
    "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."
}