{
  "url": "https://openlegislation.uk/eu-directive-2005-61/annex-II/part-D",
  "json_url": "https://openlegislation.uk/eu-directive-2005-61/annex-II/part-D.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/D",
  "kind": "part",
  "number": "D",
  "heading": "Annual notification format for serious adverse reactions",
  "text": "Reporting establishment\nReporting period\nThis Table refers to[ ] Whole blood [ ] Red blood cells [ ] Platelets [ ] Plasma [ ] Other (use separate table for each component)\nNumber of units issued (total number of units issued with a given number of blood components)\nNumber of recipients transfused (total number of recipients transfused with a given number of blood components) (if available)\nNumber of units transfused (the total number of blood components (units) transfused over the reporting period) (if available)\nTotal number reported\nNumber of serious adverse reactions with imputability level 0 to 3 after confirmation (see Annex IIA)\nNumber of deaths\nnot assessable\nLevel0\nLevel1\nLevel2\nLevel3\nImmunological Haemolysis\nDue to ABO incompatibility\nTotal\nDeaths\nDue to other allo-antibody\nTotal\nDeaths\nNon-immunological haemolysis\nTotal\nDeaths\nTransfusion-transmitted bacterial infection\nTotal\nDeaths\nAnaphylaxis/hypersensitivity\nTotal\nDeaths\nTransfusion related acute lung injury\nTotal\nDeaths\nTransfusion-transmitted viral Infection\nHBV\nTotal\nDeaths\nHCV\nTotal\nDeaths\nHIV-1/2\nTotal\nDeaths\nOther (specify)\nTotal\nDeaths\nTransfusion-transmitted parasitical infection\nMalaria\nTotal\nDeaths\nOther (specify)\nTotal\nDeaths\nPost-transfusion purpura\nTotal\nDeaths\nGraft versus host disease\nTotal\nDeaths\nOther serious reactions (specify)\nTotal\nDeaths",
  "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/D",
    "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."
}