{
  "url": "https://openlegislation.uk/eu-regulation-2017-1569",
  "json_url": "https://openlegislation.uk/eu-regulation-2017-1569.json",
  "id": "eur/2017/1569",
  "title": "Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (Text with EEA relevance)",
  "short_title": "Regulation (EU) 2017/1569 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the…",
  "long_title": "Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (Text with EEA relevance)",
  "citation": "EU Regulation 2017/1569",
  "type": "eur",
  "year": "2017",
  "number": "1569",
  "version": "current",
  "date": "2017-05-23",
  "revised": false,
  "valid_from": null,
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "chapter/I",
      "kind": "chapter",
      "number": "I",
      "heading": "GENERAL PROVISIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": "Subject matter",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": "Definitions",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "chapter/II",
      "kind": "chapter",
      "number": "II",
      "heading": "GOOD MANUFACTURING PRACTICE",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "Conformity with good manufacturing practice",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Compliance with clinical trial authorisation",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Pharmaceutical quality system",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Personnel",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/7",
      "kind": "article",
      "number": "7",
      "heading": "Premises and equipment",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Documentation",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": "Production",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": "Quality control",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/11",
      "kind": "article",
      "number": "11",
      "heading": "Retention of samples used for quality control",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/12",
      "kind": "article",
      "number": "12",
      "heading": "Responsibilities of the qualified person",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-12",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/13",
      "kind": "article",
      "number": "13",
      "heading": "Outsourced operations",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-13",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/14",
      "kind": "article",
      "number": "14",
      "heading": "Complaints, product recall and emergency unblinding",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-14",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/15",
      "kind": "article",
      "number": "15",
      "heading": "Self-inspection by the manufacturer",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-15",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/16",
      "kind": "article",
      "number": "16",
      "heading": "Advanced therapy investigational medicinal products",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-16",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "chapter/III",
      "kind": "chapter",
      "number": "III",
      "heading": "INSPECTIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/17",
      "kind": "article",
      "number": "17",
      "heading": "Supervision by inspection",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-17",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/18",
      "kind": "article",
      "number": "18",
      "heading": "Cooperation and coordination of inspections",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-18",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/19",
      "kind": "article",
      "number": "19",
      "heading": "Recognition of inspection conclusions",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-19",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/20",
      "kind": "article",
      "number": "20",
      "heading": "Empowerments of the inspectors",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-20",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/21",
      "kind": "article",
      "number": "21",
      "heading": "Competence and obligations of the inspectors",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-21",
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      "status": null,
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    },
    {
      "path": "article/22",
      "kind": "article",
      "number": "22",
      "heading": "Quality system",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-22",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/23",
      "kind": "article",
      "number": "23",
      "heading": "Impartiality of inspectors",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-23",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/24",
      "kind": "article",
      "number": "24",
      "heading": "Access to premises",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-24",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/25",
      "kind": "article",
      "number": "25",
      "heading": "Suspension or revocation of manufacturing authorisation",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-25",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "chapter/IV",
      "kind": "chapter",
      "number": "IV",
      "heading": "FINAL PROVISIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/26",
      "kind": "article",
      "number": "26",
      "heading": "Transitional provision",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-26",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/27",
      "kind": "article",
      "number": "27",
      "heading": "Entry into force",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/article-27",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-regulation-2017-1569/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    }
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    "retrieved_at": "2026-11-01T14:44:34.669471+00:00"
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  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
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}