{
  "url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-F/division-1",
  "json_url": "https://openlegislation.uk/eu-directive-2006-86/annex-I/division-F/division-1.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/I/division/F/division/1",
  "kind": "division",
  "number": "1",
  "heading": null,
  "text": "An audit system must be in place for the activities for which accreditation/designation/authorisation/licensing is sought. Trained and competent persons must conduct the audit in an independent way, at least every two years, in order to verify compliance with the approved protocols and the regulatory requirements. Findings and corrective actions must be documented.",
  "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/2006/86/annex/I/division/F/division/1",
    "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."
}