{
  "url": "https://openlegislation.uk/eu-directive-2006-17/annex-IV/division-2/division-2.4",
  "json_url": "https://openlegislation.uk/eu-directive-2006-17/annex-IV/division-2/division-2.4.json",
  "legislation": "eudr/2006/17",
  "legislation_title": "Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2006-17",
  "path": "annex/IV/division/2/division/2.4",
  "kind": "division",
  "number": "2.4",
  "heading": "The data that must be registered at the tissue establishment (except for donors of reproductive cells intended for partner donation) include:",
  "text": "(a) consent/authorisation; including the purpose(s) for which the tissues and cells may be used (i.e. therapeutic or research, or both therapeutic use and research) and any specific instructions for disposal if the tissue or cells are not used for the purpose for which consent was obtained;\n(b) all required records relating to the procurement and the taking of the donor history, as described in the donor documentation section;\n(c) results of physical examination, of laboratory tests and of other tests (such as the autopsy report, if used in accordance with point 1.2.2.);\n(d) for allogeneic donors, a properly documented review of the complete donor evaluation against the selection criteria by an authorised and trained person;\n(e) in the case of cell cultures intended for autologous use, documentation of the possibility of medicinal allergies (such as to antibiotics) of the recipient.",
  "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/2006/17/annex/IV/division/2/division/2.4",
    "retrieved_at": "2026-11-01T15:22:38.416524+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."
}