{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-17B",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-17B.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/17B",
  "kind": "regulation",
  "number": "17B",
  "heading": "Manufacturing of POC medicinal products",
  "text": "A person may not manufacture or assemble a POC medicinal product unless—\n(a) it is specified in a manufacturer’s licence (POC); and\n(b) there is a POC master file relating to that product and it is manufactured or assembled in accordance with that master file.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Regs. 17A, 17B inserted (23.7.2025) by The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (S.I. 2025/87), regs. 1(2), 6"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/17B",
    "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."
}