{
  "url": "https://openlegislation.uk/eu-directive-2005-61/annex-II/part-C",
  "json_url": "https://openlegislation.uk/eu-directive-2005-61/annex-II/part-C.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/C",
  "kind": "part",
  "number": "C",
  "heading": "Confirmation format for serious adverse reactions",
  "text": "Reporting establishment\nReport identification\nConfirmation date (year/month/day)\nDate of serious adverse reaction (year/month/day)\nConfirmation of serious adverse reaction (Yes/No)\nImputability level (NA, 0-3)\nChange of type of serious adverse reaction (Yes/No)\nIf Yes, specify\nClinical outcome (if known)\nComplete recovery\nMinor sequelae\nSerious sequelae\nDeath",
  "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/C",
    "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."
}