{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-257C",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-257C.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/257C",
  "kind": "regulation",
  "number": "257C",
  "heading": "Packaging requirements: advanced therapy medicinal products",
  "text": "(1) The information specified in Part 4 of Schedule 24 must appear—\n(a) on the outer packaging of an advanced therapy medicinal product ... (other than an exempt advanced therapy medicinal product); and\n(b) on the immediate packaging of that product, unless paragraph (2) or (3) applies to the packaging.\n(2) This paragraph applies to the immediate packaging if the packaging is in the form of a blister pack and is placed in outer packaging which complies with the requirements of Part 4 of Schedule 24.\n(3) This paragraph applies to immediate packaging if the packaging is too small to display the information required by Part 4 of Schedule 24.\n(4) The information specified in Part 5 of Schedule 24 must appear on immediate packaging to which paragraph (2) or (3) applies.\n(5) Nothing in this regulation applies to an advanced therapy medicinal product that is a POC medicinal product, if the entirety of the product is to be administered immediately after manufacture.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 257C-257E inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 200 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 154); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 257C(1)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 114"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Reg. 257C(5) inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 30"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/257C",
    "retrieved_at": "2026-10-29T01:24:34.993203+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."
}