{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-8/paragraph-16",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-8/paragraph-16.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/8/paragraph/16",
  "kind": "paragraph",
  "number": "16",
  "heading": null,
  "text": "(1) Subject to sub-paragraph (2), a mock-up, in accordance with Part 13 (packaging and leaflets) of—\n(a) the outer packaging of the medicinal product;\n(b) the immediate packaging of the medicinal product; and\n(c) the package leaflet for the medicinal product.\n(2) Sub-paragraph (1)(a) and (b) does not apply to an application for a marketing authorisation for a POC medicinal product which is (or is in a form which means a dose or part of it is) to be administered immediately after manufacture.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 8 para. 16 substituted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 37(3)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/8/paragraph/16",
    "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."
}