{
  "url": "https://openlegislation.uk/eu-directive-2002-98/article-15",
  "json_url": "https://openlegislation.uk/eu-directive-2002-98/article-15.json",
  "legislation": "eudr/2002/98",
  "legislation_title": "Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC",
  "legislation_url": "https://openlegislation.uk/eu-directive-2002-98",
  "path": "article/15",
  "kind": "article",
  "number": "15",
  "heading": "Notification of serious adverse events and reactions",
  "text": "1. Member States shall ensure that:\nany serious adverse events (accidents and errors) related to the collection, testing, processing, storage and distribution of blood and blood components which may have an influence on their quality and safety, as well as any serious adverse reactions observed during or after transfusion which may be attributed to the quality and the safety of blood and blood components are notified to the competent authority,\nblood establishments have in place a procedure accurately, efficiently and verifiably to withdraw from distribution blood or blood components associated with the notification referred to above.\n2. These serious adverse events and reactions shall be notified in accordance with the procedure and notification format referred to in Article 29(i).",
  "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/2002/98/article/15",
    "retrieved_at": "2026-11-01T15:22:54.973908+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."
}