{
  "url": "https://openlegislation.uk/eu-directive-2006-86/article-9",
  "json_url": "https://openlegislation.uk/eu-directive-2006-86/article-9.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": "article/9",
  "kind": "article",
  "number": "9",
  "heading": "Traceability",
  "text": "1. Member States shall ensure that tissues and cells shall be traceable in particular through documentation and the use of the Single European Code from procurement to human application or disposal and vice versa. Tissues and cells used for advanced therapy medicinal products shall be traceable under this Directive at least until transferred to the ATMP manufacturer.\n2. Member States shall ensure that tissue establishments and organisations responsible for human application shall retain the data set out in Annex VI for at least 30 years, using an appropriate and readable storage medium.\n3. In case of tissues and cells retrieved from a deceased donor by procurement teams operating for two or more tissue establishments, Member States shall ensure an appropriate traceability system across the procurements.",
  "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/article/9",
    "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."
}