{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-B17",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/regulation-B17.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "regulation/B17",
  "kind": "regulation",
  "number": "B17",
  "heading": "Regulations on good manufacturing practice",
  "text": "(1) The Secretary of State may by regulations in respect of Great Britain set out principles and guidelines of good manufacturing practice in respect of medicinal products and investigational medicinal products.\n(2) Regulations under paragraph (1) may in particular make provisions as to—\n(a) inspections;\n(b) compliance with good manufacturing practice and, where relevant, the UK marketing authorisation ...;\n(c) quality assurance systems;\n(d) personnel;\n(e) premises and equipment;\n(f) documentation;\n(g) production;\n(h) quality control;\n(i) the contracting out of work;\n(j) complaints and product recall;\n(k) self-inspection.\n(3) Subject to any provision made in regulations under paragraph (1), the principles and guidelines set out in the Good Manufacturing Practice Directive have effect in Great Britain on and after IP completion day as they had effect immediately before IP completion day, but subject to the modifications specified in Schedule 2A.\n(4) The Secretary of State may by regulations in respect of Great Britain amend or revoke Schedule 2A.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Pt. 3 Ch. 1A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 13 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 8); 2020 c. 1, Sch. 5 para. 1(1)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Words in reg. B17(2)(b) 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), 8"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/regulation/B17",
    "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."
}