{
  "url": "https://openlegislation.uk/eu-directive-2002-98",
  "json_url": "https://openlegislation.uk/eu-directive-2002-98.json",
  "id": "eudr/2002/98",
  "title": "Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC",
  "short_title": "Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC",
  "long_title": "Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC",
  "citation": "EU Directive 2002/98",
  "type": "eudr",
  "year": "2002",
  "number": "98",
  "version": "current",
  "date": "2003-01-27",
  "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-2002-98/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": "Objectives",
      "url": "https://openlegislation.uk/eu-directive-2002-98/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-2002-98/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-2002-98/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-2002-98/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": "Designation, authorisation, accreditation or licensing of blood establishments",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Hospital blood banks",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/7",
      "kind": "article",
      "number": "7",
      "heading": "Provisions for existing establishments",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Inspection and control measures",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/II"
    },
    {
      "path": "chapter/III",
      "kind": "chapter",
      "number": "III",
      "heading": "PROVISIONS FOR BLOOD ESTABLISHMENTS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": "Responsible person",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": "Personnel",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/III"
    },
    {
      "path": "chapter/IV",
      "kind": "chapter",
      "number": "IV",
      "heading": "QUALITY MANAGEMENT",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/11",
      "kind": "article",
      "number": "11",
      "heading": "Quality system for blood establishments",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/12",
      "kind": "article",
      "number": "12",
      "heading": "Documentation",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-12",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "article/13",
      "kind": "article",
      "number": "13",
      "heading": "Record keeping",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-13",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IV"
    },
    {
      "path": "chapter/V",
      "kind": "chapter",
      "number": "V",
      "heading": "HAEMOVIGILANCE",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/14",
      "kind": "article",
      "number": "14",
      "heading": "Traceability",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-14",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "article/15",
      "kind": "article",
      "number": "15",
      "heading": "Notification of serious adverse events and reactions",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-15",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/V"
    },
    {
      "path": "chapter/VI",
      "kind": "chapter",
      "number": "VI",
      "heading": "PROVISIONS FOR THE QUALITY AND SAFETY OF BLOOD AND BLOOD COMPONENTS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/16",
      "kind": "article",
      "number": "16",
      "heading": "Provision of information to prospective donors",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-16",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/17",
      "kind": "article",
      "number": "17",
      "heading": "Information required from donors",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-17",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/18",
      "kind": "article",
      "number": "18",
      "heading": "Eligibility of donors",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-18",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/19",
      "kind": "article",
      "number": "19",
      "heading": "Examination of donors",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-19",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/20",
      "kind": "article",
      "number": "20",
      "heading": "Voluntary and unpaid blood donation",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-20",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/21",
      "kind": "article",
      "number": "21",
      "heading": "Testing of donations",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-21",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/22",
      "kind": "article",
      "number": "22",
      "heading": "Storage, transport and distribution conditions",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-22",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "article/23",
      "kind": "article",
      "number": "23",
      "heading": "Quality and safety requirements for blood and blood components",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-23",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VI"
    },
    {
      "path": "chapter/VII",
      "kind": "chapter",
      "number": "VII",
      "heading": "DATA PROTECTION",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/24",
      "kind": "article",
      "number": "24",
      "heading": "Data protection and confidentiality",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-24",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VII"
    },
    {
      "path": "chapter/VIII",
      "kind": "chapter",
      "number": "VIII",
      "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": "Information exchange",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-25",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/26",
      "kind": "article",
      "number": "26",
      "heading": "Reports",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-26",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "article/27",
      "kind": "article",
      "number": "27",
      "heading": "Penalties",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-27",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/VIII"
    },
    {
      "path": "chapter/IX",
      "kind": "chapter",
      "number": "IX",
      "heading": "COMMITTEES",
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      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/28",
      "kind": "article",
      "number": "28",
      "heading": "Committee procedure",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-28",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "article/29",
      "kind": "article",
      "number": "29",
      "heading": "Technical requirements and their adaptation to technical and scientific progress",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-29",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "article/30",
      "kind": "article",
      "number": "30",
      "heading": "Consultation of scientific committee(s)",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-30",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/IX"
    },
    {
      "path": "chapter/X",
      "kind": "chapter",
      "number": "X",
      "heading": "FINAL PROVISIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/31",
      "kind": "article",
      "number": "31",
      "heading": "Amendment of Directive 2001/83/EC",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-31",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "article/32",
      "kind": "article",
      "number": "32",
      "heading": "Transposition",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-32",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "article/33",
      "kind": "article",
      "number": "33",
      "heading": "Entry into force",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-33",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "article/34",
      "kind": "article",
      "number": "34",
      "heading": "Addressees",
      "url": "https://openlegislation.uk/eu-directive-2002-98/article-34",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "chapter/X"
    },
    {
      "path": "annex/I",
      "kind": "annex",
      "number": "I",
      "heading": "INFORMATION TO BE PROVIDED BY BLOOD ESTABLISHMENT TO THE COMPETENT AUTHORITY FOR THE PURPOSES OF DESIGNATION, AUTHORISATION, ACCREDITATION OR LICENSING IN ACCORDANCE WITH ARTICLE 5(2)",
      "url": null,
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      "status": null,
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    },
    {
      "path": "annex/I/part/A",
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      "number": "A:",
      "heading": "General information:",
      "url": "https://openlegislation.uk/eu-directive-2002-98/annex-I/part-A",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/part/B",
      "kind": "part",
      "number": "B:",
      "heading": "A description of the quality system, to include:",
      "url": "https://openlegislation.uk/eu-directive-2002-98/annex-I/part-B",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/II",
      "kind": "annex",
      "number": "II",
      "heading": "REPORT OF THE BLOOD ESTABLISHMENT'S PRECEDING YEAR'S ACTIVITY",
      "url": "https://openlegislation.uk/eu-directive-2002-98/annex-II",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/III",
      "kind": "annex",
      "number": "III",
      "heading": "LABELLING REQUIREMENTS",
      "url": "https://openlegislation.uk/eu-directive-2002-98/annex-III",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/IV",
      "kind": "annex",
      "number": "IV",
      "heading": "BASIC TESTING REQUIREMENTS FOR WHOLE BLOOD AND PLASMA DONATIONS",
      "url": "https://openlegislation.uk/eu-directive-2002-98/annex-IV",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    }
  ],
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  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2002/98",
    "retrieved_at": "2026-11-01T15:22:54.973908+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."
}