{
  "url": "https://openlegislation.uk/eu-directive-2005-61/annex-II/part-B",
  "json_url": "https://openlegislation.uk/eu-directive-2005-61/annex-II/part-B.json",
  "legislation": "eudr/2005/61",
  "legislation_title": "Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2005-61",
  "path": "annex/II/part/B",
  "kind": "part",
  "number": "B",
  "heading": null,
  "text": "Serious adverse reactions — imputability levels\nImputability levels to assess serious adverse reactions.\nImputability level\nExplanation\nNA\nNot assessable\nWhen there is insufficient data for imputability assessment.\n0\nExcluded\nWhen there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to alternative causes.\nUnlikely\nWhen the evidence is clearly in favour of attributing the adverse reaction to causes other than the blood or blood components.\n1\nPossible\nWhen the evidence is indeterminate for attributing adverse reaction either to the blood or blood component or to alternative causes.\n2\nLikely, Probable\nWhen the evidence is clearly in favour of attributing the adverse reaction to the blood or blood component.\n3\nCertain\nWhen there is conclusive evidence beyond reasonable doubt for attributing the adverse reaction to the blood or blood component.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2005/61/annex/II/part/B",
    "retrieved_at": "2026-11-01T15:22:40.913360+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."
}