{
  "url": "https://openlegislation.uk/eu-directive-2006-86/annex-II/division-E/division-2",
  "json_url": "https://openlegislation.uk/eu-directive-2006-86/annex-II/division-E/division-2.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": "annex/II/division/E/division/2",
  "kind": "division",
  "number": "2",
  "heading": "The following information must be provided either on the label or in accompanying documentation:",
  "text": "(a) description (definition) and, if relevant, dimensions of the tissue or cell product;\n(b) morphology and functional data where relevant;\n(c) date of distribution of the tissue/cells;\n(d) biological determinations carried out on the donor and results;\n(e) storage recommendations;\n(f) instructions for opening the container, package, and any required manipulation/reconstitution;\n(g) expiry dates after opening/manipulation;\n(h) instructions for reporting serious adverse reactions and/or events as set out in Articles 5 to 6;\n(i) presence of potential harmful residues (e.g. antibiotics, ethylene oxide etc);\n(j) for imported tissues and cells, the country of procurement and the exporting country (if different from the procurement country).",
  "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)."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Inserted 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/annex/II/division/E/division/2",
    "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."
}