{
  "url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-198",
  "json_url": "https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-198.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/198",
  "kind": "regulation",
  "number": "198",
  "heading": "Amendment of regulation 257 (packaging requirements: general)",
  "text": "(1) Regulation 257 is amended as follows.\n(2) In paragraph (6), after “this regulation,” insert “ regulation 257C where the product is for sale or supply in Great Britain only,”.\n(3) After paragraph (7) insert—\n“(8) Nothing in this regulation applies to the outer or immediate packaging of an advanced therapy medicinal product for sale or supply in Great Britain only.”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 198(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. 152(a)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 198(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. 152(b)"
    },
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 198 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/198",
    "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."
}