{
  "url": "https://openlegislation.uk/eu-directive-2006-86/annex-III/part-B",
  "json_url": "https://openlegislation.uk/eu-directive-2006-86/annex-III/part-B.json",
  "legislation": "eudr/2006/86",
  "legislation_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)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2006-86",
  "path": "annex/III/part/B",
  "kind": "division",
  "number": "PART B",
  "heading": "Conclusions of Serious Adverse Reactions Investigation",
  "text": "Tissue establishment\nEU tissue establishment code (if applicable)\nReport identification\nConfirmation date (year/month/day)\nDate of serious adverse reaction (year/month/day)\nUnique donation identification number\nConfirmation of serious adverse reaction (Yes/No)\nSingle European Code of tissues or cells involved in the confirmed serious adverse reaction (if applicable)\nChange of type of serious adverse reaction (Yes/No) If YES, specify\nClinical outcome (if known)\nComplete recovery\nMinor sequelae\nSerious sequelae\nDeath\nOutcome of the investigation and final conclusions\nRecommendations for preventive and corrective actions",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (Text with EEA relevance)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2006/86/annex/III/part/B",
    "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."
}