{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-259",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-259.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/259",
  "kind": "regulation",
  "number": "259",
  "heading": "Packaging requirements: information for blind and partially sighted patients",
  "text": "(1) The name of a medicinal product must also be expressed in Braille format on the outer packaging of the product (or, if there is no outer packaging, on the immediate packaging of the product).\n(2) The holder of a UK marketing authorisation, ..., Article 126a authorisation or traditional herbal registration for a medicinal product must ensure that the package leaflet is made available on request in formats suitable for blind and partially-sighted persons.\n(3) Nothing in this regulation applies to a registrable homoeopathic medicinal product.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Words in reg. 259(2) substituted (31.12.2020) by S.I. 2019/775, reg. 202 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 156)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. 259(2) 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), 116"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/259",
    "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."
}