{
  "url": "https://openlegislation.uk/eu-directive-2006-86",
  "json_url": "https://openlegislation.uk/eu-directive-2006-86.json",
  "id": "eudr/2006/86",
  "title": "Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (Text with EEA relevance)",
  "short_title": "Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells",
  "long_title": "Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (Text with EEA relevance)",
  "citation": "EU Directive 2006/86",
  "type": "eudr",
  "year": "2006",
  "number": "86",
  "version": "current",
  "date": "2006-10-24",
  "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-2006-86/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": "Scope",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": "Definitions",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "Requirements for the accreditation, designation, authorisation or licensing of tissue establishments",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Requirements for the accreditation, designation, authorisation, licensing of tissue and cell preparation processes",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Notification of serious adverse reactions",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Notification of serious adverse events",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/7",
      "kind": "article",
      "number": "7",
      "heading": "Annual reports",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Communication of information between competent authorities and to the Commission",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": "Traceability",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": "European coding system",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-10",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/10a",
      "kind": "article",
      "number": "10a",
      "heading": "Format of the Single European Code",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-10a",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/10b",
      "kind": "article",
      "number": "10b",
      "heading": "Requirements related to the application of the Single European Code",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-10b",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/10c",
      "kind": "article",
      "number": "10c",
      "heading": "Accessibility and maintenance of the European coding system",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-10c",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/10d",
      "kind": "article",
      "number": "10d",
      "heading": "Transitional period",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-10d",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/11",
      "kind": "article",
      "number": "11",
      "heading": "Transposition",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-11",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/12",
      "kind": "article",
      "number": "12",
      "heading": "Entry into force",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-12",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/13",
      "kind": "article",
      "number": "13",
      "heading": "Addressees",
      "url": "https://openlegislation.uk/eu-directive-2006-86/article-13",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/I",
      "kind": "annex",
      "number": "I",
      "heading": "Requirements for accreditation, designation, authorisation or licensing of tissue establishments as referred to in Article 3",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/I/division/A",
      "kind": "division",
      "number": "A",
      "heading": "ORGANISATION AND MANAGEMENT",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/A/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-A/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/A"
    },
    {
      "path": "annex/I/division/A/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-A/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/A"
    },
    {
      "path": "annex/I/division/A/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-A/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/A"
    },
    {
      "path": "annex/I/division/A/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-A/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/A"
    },
    {
      "path": "annex/I/division/A/division/5",
      "kind": "division",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-A/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/A"
    },
    {
      "path": "annex/I/division/A/division/6",
      "kind": "division",
      "number": "6",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-A/division-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/A"
    },
    {
      "path": "annex/I/division/A/division/7",
      "kind": "division",
      "number": "7",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-A/division-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/A"
    },
    {
      "path": "annex/I/division/A/division/8",
      "kind": "division",
      "number": "8",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-A/division-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/A"
    },
    {
      "path": "annex/I/division/A/division/9",
      "kind": "division",
      "number": "9",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-A/division-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/A"
    },
    {
      "path": "annex/I/division/B",
      "kind": "division",
      "number": "B",
      "heading": "PERSONNEL",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/B/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-B/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/B"
    },
    {
      "path": "annex/I/division/B/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-B/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/B"
    },
    {
      "path": "annex/I/division/B/division/3",
      "kind": "division",
      "number": "3",
      "heading": "Personnel must be provided with initial/basic training, updated training as required when procedures change or scientific knowledge develops and adequate opportunities for relevant professional development. The training programme must ensure and document that each individual:",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-B/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/B"
    },
    {
      "path": "annex/I/division/C",
      "kind": "division",
      "number": "C",
      "heading": "EQUIPMENT AND MATERIALS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/C/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-C/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/C"
    },
    {
      "path": "annex/I/division/C/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-C/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/C"
    },
    {
      "path": "annex/I/division/C/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-C/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/C"
    },
    {
      "path": "annex/I/division/C/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-C/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/C"
    },
    {
      "path": "annex/I/division/C/division/5",
      "kind": "division",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-C/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/C"
    },
    {
      "path": "annex/I/division/C/division/6",
      "kind": "division",
      "number": "6",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-C/division-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/C"
    },
    {
      "path": "annex/I/division/D",
      "kind": "division",
      "number": "D",
      "heading": "FACILITIES/PREMISES",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/D/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-D/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-D/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-D/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/4",
      "kind": "division",
      "number": "4",
      "heading": "A less stringent environment than specified in point 3 may be acceptable where:",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-D/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/5",
      "kind": "division",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-D/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/6",
      "kind": "division",
      "number": "6",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-D/division-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/7",
      "kind": "division",
      "number": "7",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-D/division-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/8",
      "kind": "division",
      "number": "8",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-D/division-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/D/division/9",
      "kind": "division",
      "number": "9",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-D/division-9",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/D"
    },
    {
      "path": "annex/I/division/E",
      "kind": "division",
      "number": "E",
      "heading": "DOCUMENTATION AND RECORDS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/E/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-E/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/E"
    },
    {
      "path": "annex/I/division/E/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-E/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/E"
    },
    {
      "path": "annex/I/division/E/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-E/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/E"
    },
    {
      "path": "annex/I/division/E/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-E/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/E"
    },
    {
      "path": "annex/I/division/E/division/5",
      "kind": "division",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-E/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/E"
    },
    {
      "path": "annex/I/division/E/division/6",
      "kind": "division",
      "number": "6",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-E/division-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/E"
    },
    {
      "path": "annex/I/division/E/division/7",
      "kind": "division",
      "number": "7",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-E/division-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/E"
    },
    {
      "path": "annex/I/division/E/division/8",
      "kind": "division",
      "number": "8",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-E/division-8",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/E"
    },
    {
      "path": "annex/I/division/F",
      "kind": "division",
      "number": "F",
      "heading": "QUALITY REVIEW",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I"
    },
    {
      "path": "annex/I/division/F/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-F/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/F"
    },
    {
      "path": "annex/I/division/F/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-F/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/F"
    },
    {
      "path": "annex/I/division/F/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-F/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/F"
    },
    {
      "path": "annex/I/division/F/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-F/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/I/division/F"
    },
    {
      "path": "annex/II",
      "kind": "annex",
      "number": "II",
      "heading": "Requirements for the authorisation of tissue and cell preparation processes at the tissue establishments as referred to in Article 4",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-II",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/II/division/A",
      "kind": "division",
      "number": "A",
      "heading": "RECEPTION AT THE TISSUE ESTABLISHMENT",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-II/division-A",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II"
    },
    {
      "path": "annex/II/division/B",
      "kind": "division",
      "number": "B",
      "heading": "PROCESSING",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-II/division-B",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II"
    },
    {
      "path": "annex/II/division/C",
      "kind": "division",
      "number": "C",
      "heading": "STORAGE AND RELEASE OF PRODUCTS",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-II/division-C",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II"
    },
    {
      "path": "annex/II/division/D",
      "kind": "division",
      "number": "D",
      "heading": "DISTRIBUTION AND RECALL",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-II/division-D",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II"
    },
    {
      "path": "annex/II/division/E",
      "kind": "division",
      "number": "E",
      "heading": "FINAL LABELLING FOR DISTRIBUTION",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II"
    },
    {
      "path": "annex/II/division/E/division/1",
      "kind": "division",
      "number": "1",
      "heading": "The primary tissue/cell container must provide:",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-II/division-E/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/division/E"
    },
    {
      "path": "annex/II/division/E/division/2",
      "kind": "division",
      "number": "2",
      "heading": "The following information must be provided either on the label or in accompanying documentation:",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-II/division-E/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II/division/E"
    },
    {
      "path": "annex/II/division/F",
      "kind": "division",
      "number": "F",
      "heading": "EXTERNAL LABELLING OF THE SHIPPING CONTAINER",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-II/division-F",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/II"
    },
    {
      "path": "annex/III",
      "kind": "annex",
      "number": "III",
      "heading": "NOTIFICATION OF SERIOUS ADVERSE REACTIONS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/III/part/A",
      "kind": "division",
      "number": "PART A",
      "heading": "Rapid notification for suspected serious adverse reactions",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-III/part-A",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III"
    },
    {
      "path": "annex/III/part/B",
      "kind": "division",
      "number": "PART B",
      "heading": "Conclusions of Serious Adverse Reactions Investigation",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-III/part-B",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/III"
    },
    {
      "path": "annex/IV",
      "kind": "annex",
      "number": "IV",
      "heading": "NOTIFICATION OF SERIOUS ADVERSE EVENTS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/IV/part/A",
      "kind": "division",
      "number": "PART A",
      "heading": "Rapid notification for suspected serious adverse events",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-IV/part-A",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/IV"
    },
    {
      "path": "annex/IV/part/B",
      "kind": "division",
      "number": "PART B",
      "heading": "Conclusions of Serious Adverse Events investigation",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-IV/part-B",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/IV"
    },
    {
      "path": "annex/V",
      "kind": "annex",
      "number": "V",
      "heading": "ANNUAL NOTIFICATION FORMAT",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-V",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/VI",
      "kind": "annex",
      "number": "VI",
      "heading": "Minimum data to be kept in accordance with Article 9(2)",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/VI/division/A",
      "kind": "division",
      "number": "A",
      "heading": "BY TISSUE ESTABLISHMENTS",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VI"
    },
    {
      "path": "annex/VI/division/A/division/1",
      "kind": "division",
      "number": "(1)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VI/division-A/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VI/division/A"
    },
    {
      "path": "annex/VI/division/A/division/2",
      "kind": "division",
      "number": "(2)",
      "heading": "Donation identification that will include at least:",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VI/division-A/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VI/division/A"
    },
    {
      "path": "annex/VI/division/A/division/3",
      "kind": "division",
      "number": "(3)",
      "heading": "Product identification that will include at least:",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VI/division-A/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VI/division/A"
    },
    {
      "path": "annex/VI/division/A/division/4",
      "kind": "division",
      "number": "(4)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VI/division-A/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VI/division/A"
    },
    {
      "path": "annex/VI/division/A/division/5",
      "kind": "division",
      "number": "(5)",
      "heading": "Human application identification that will include at least:",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VI/division-A/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VI/division/A"
    },
    {
      "path": "annex/VI/division/B",
      "kind": "division",
      "number": "B",
      "heading": "BY ORGANISATIONS RESPONSIBLE FOR HUMAN APPLICATION",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VI"
    },
    {
      "path": "annex/VI/division/B/division/1",
      "kind": "division",
      "number": "(1)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VI/division-B/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VI/division/B"
    },
    {
      "path": "annex/VI/division/B/division/2",
      "kind": "division",
      "number": "(2)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VI/division-B/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VI/division/B"
    },
    {
      "path": "annex/VI/division/B/division/3",
      "kind": "division",
      "number": "(3)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VI/division-B/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VI/division/B"
    },
    {
      "path": "annex/VI/division/B/division/4",
      "kind": "division",
      "number": "(4)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VI/division-B/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VI/division/B"
    },
    {
      "path": "annex/VI/division/B/division/5",
      "kind": "division",
      "number": "(5)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VI/division-B/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VI/division/B"
    },
    {
      "path": "annex/VI/division/B/division/6",
      "kind": "division",
      "number": "(6)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VI/division-B/division-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VI/division/B"
    },
    {
      "path": "annex/VI/division/B/division/7",
      "kind": "division",
      "number": "(7)",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VI/division-B/division-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VI/division/B"
    },
    {
      "path": "annex/VII",
      "kind": "annex",
      "number": "VII",
      "heading": "THE STRUCTURE OF THE SINGLE EUROPEAN CODE",
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VII",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/VIII",
      "kind": "annex",
      "number": "VIII",
      "heading": "Data to be recorded in the EU Tissue Establishment Compendium",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex/VIII/division/A",
      "kind": "division",
      "number": "A",
      "heading": "Tissue establishment information",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VIII"
    },
    {
      "path": "annex/VIII/division/A/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VIII/division-A/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VIII/division/A"
    },
    {
      "path": "annex/VIII/division/A/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VIII/division-A/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VIII/division/A"
    },
    {
      "path": "annex/VIII/division/A/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VIII/division-A/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VIII/division/A"
    },
    {
      "path": "annex/VIII/division/A/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VIII/division-A/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VIII/division/A"
    },
    {
      "path": "annex/VIII/division/A/division/5",
      "kind": "division",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VIII/division-A/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VIII/division/A"
    },
    {
      "path": "annex/VIII/division/B",
      "kind": "division",
      "number": "B",
      "heading": "Details on the authorisation, accreditation, designation, or license of the tissue establishment",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VIII"
    },
    {
      "path": "annex/VIII/division/B/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VIII/division-B/division-1",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VIII/division/B"
    },
    {
      "path": "annex/VIII/division/B/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VIII/division-B/division-2",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VIII/division/B"
    },
    {
      "path": "annex/VIII/division/B/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VIII/division-B/division-3",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VIII/division/B"
    },
    {
      "path": "annex/VIII/division/B/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VIII/division-B/division-4",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VIII/division/B"
    },
    {
      "path": "annex/VIII/division/B/division/5",
      "kind": "division",
      "number": "5",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VIII/division-B/division-5",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VIII/division/B"
    },
    {
      "path": "annex/VIII/division/B/division/6",
      "kind": "division",
      "number": "6",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VIII/division-B/division-6",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VIII/division/B"
    },
    {
      "path": "annex/VIII/division/B/division/7",
      "kind": "division",
      "number": "7",
      "heading": null,
      "url": "https://openlegislation.uk/eu-directive-2006-86/annex-VIII/division-B/division-7",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": "annex/VIII/division/B"
    }
  ],
  "outstanding_effects": [],
  "made_under": [],
  "changes_made_to": 29,
  "changes_made_to_url": "https://openlegislation.uk/eu-directive-2006-86/changes.json",
  "changes_made_by": 0,
  "changes_made_by_url": "https://openlegislation.uk/eu-directive-2006-86/changes/by-it.json",
  "instruments_made_under": 0,
  "instruments_made_under_url": "https://openlegislation.uk/eu-directive-2006-86/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2006/86",
    "retrieved_at": "2026-11-01T15:22:33.600657+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."
}