{
  "url": "https://openlegislation.uk/eu-directive-2004-23",
  "json_url": "https://openlegislation.uk/eu-directive-2004-23.json",
  "id": "eudr/2004/23",
  "title": "Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells",
  "short_title": "Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells",
  "long_title": "Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells",
  "citation": "EU Directive 2004/23",
  "type": "eudr",
  "year": "2004",
  "number": "23",
  "version": "current",
  "date": "2004-03-31",
  "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-directive-2004-23/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": "Objective",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": "Scope",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "Definitions",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Implementation",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/I"
    },
    {
      "path": "chapter/II",
      "kind": "chapter",
      "number": "II",
      "heading": "OBLIGATIONS ON MEMBER STATES' AUTHORITIES",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Supervision of human tissue and cell procurement",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Accreditation, designation, authorisation or licensing of tissue establishments and tissue and cell preparation processes",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/7",
      "kind": "article",
      "number": "7",
      "heading": "Inspections and control measures",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Traceability",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": "Import/export of human tissues and cells",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": "Register of tissue establishments and reporting obligations",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/11",
      "kind": "article",
      "number": "11",
      "heading": "Notification of serious adverse events and reactions",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "chapter/III",
      "kind": "chapter",
      "number": "III",
      "heading": "DONOR SELECTION AND EVALUATION",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/12",
      "kind": "article",
      "number": "12",
      "heading": "Principles governing tissue and cell donation",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-12",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/13",
      "kind": "article",
      "number": "13",
      "heading": "Consent",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-13",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/14",
      "kind": "article",
      "number": "14",
      "heading": "Data protection and confidentiality",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-14",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/15",
      "kind": "article",
      "number": "15",
      "heading": "Selection, evaluation and procurement",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-15",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "chapter/IV",
      "kind": "chapter",
      "number": "IV",
      "heading": "PROVISIONS ON THE QUALITY AND SAFETY OF TISSUES AND CELLS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/16",
      "kind": "article",
      "number": "16",
      "heading": "Quality management",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-16",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/17",
      "kind": "article",
      "number": "17",
      "heading": "Responsible person",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-17",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/18",
      "kind": "article",
      "number": "18",
      "heading": "Personnel",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-18",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/19",
      "kind": "article",
      "number": "19",
      "heading": "Tissue and cell reception",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-19",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/20",
      "kind": "article",
      "number": "20",
      "heading": "Tissue and cell processing",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-20",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/21",
      "kind": "article",
      "number": "21",
      "heading": "Tissue and cell storage conditions",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-21",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/22",
      "kind": "article",
      "number": "22",
      "heading": "Labelling, documentation and packaging",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-22",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/23",
      "kind": "article",
      "number": "23",
      "heading": "Distribution",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-23",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/24",
      "kind": "article",
      "number": "24",
      "heading": "Relations between tissue establishments and third parties",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-24",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "chapter/V",
      "kind": "chapter",
      "number": "V",
      "heading": "EXCHANGE OF INFORMATION, REPORTS AND PENALTIES",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/25",
      "kind": "article",
      "number": "25",
      "heading": "Coding of information",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-25",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/26",
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      "number": "26",
      "heading": "Reports",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-26",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/27",
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      "number": "27",
      "heading": "Penalties",
      "url": "https://openlegislation.uk/eu-directive-2004-23/article-27",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "chapter/VI",
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      "heading": "CONSULTATION OF COMMITTEES",
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      "status": null,
      "parent": null
    },
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      "path": "article/28",
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      "heading": "Technical requirements and their adaptation to scientific and technical progress",
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      "status": null,
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      "heading": "Committee",
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      "heading": "Consultation of one or more scientific committees",
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      "heading": "FINAL PROVISIONS",
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      "status": null,
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    },
    {
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      "heading": "Transposition",
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      "heading": "Entry into force",
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      "status": null,
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    },
    {
      "path": "article/33",
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      "heading": "Addressees",
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      "status": null,
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    {
      "path": "annex",
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      "heading": "INFORMATION TO BE PROVIDED ON THE DONATION OF CELLS AND/OR TISSUES",
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