{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-203",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-203.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/203",
  "kind": "regulation",
  "number": "203",
  "heading": "Amendment of regulation 260 (package leaflets)",
  "text": "(1) Regulation 260 is amended as follows.\n(2) After paragraph (1) insert—\n“(1A) If the medicinal product is an advanced therapy medicinal product for sale or supply in Great Britain only (other than an exempt advanced therapy medicinal product), the package leaflet must contain the information specified in Part 3 of Schedule 27 in the order specified in that Part.”.\n(3) In paragraph (2), after “Part 2 of that Schedule)” insert “ , or where the product is an advanced therapy medicinal product for sale or supply in Great Britain only, the information specified in Part 3 of that Schedule, ”.\n(4) In paragraph (3), for “marketing authorisation...” substitute “ UK marketing authorisation , EU marketing authorisation, ”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 203(2) inserted (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. 157(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 203(3) inserted (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. 157(b)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Words in reg. 203(4) 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. 157(c)(i)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Words in reg. 203(4) inserted (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. 157(c)(ii)"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 203 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/203",
    "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."
}