{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-7A/paragraph-21",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-7A/paragraph-21.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/7A/paragraph/21",
  "kind": "paragraph",
  "number": "21",
  "heading": null,
  "text": "A description of the arrangements for maintaining—\n(a) production records, including records of manufacture and assembly;\n(b) records of analytical and other tests used in the course of manufacture or assembly for ensuring compliance of materials use in manufacture, or of active substances, with the specification for such materials or active substances;\n(c) records of importation;\n(d) records of storage and distribution.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 7A inserted (20.8.2013) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(1), 33"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/7A/paragraph/21",
    "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."
}