{
  "url": "https://openlegislation.uk/eu-directive-2004-9/annex-I/part-B/division-13",
  "json_url": "https://openlegislation.uk/eu-directive-2004-9/annex-I/part-B/division-13.json",
  "legislation": "eudr/2004/9",
  "legislation_title": "Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2004-9",
  "path": "annex/I/part/B/division/13",
  "kind": "division",
  "number": null,
  "heading": "Biological test systems",
  "text": "Taking account of the relevant aspects referred to above relating to care, housing or containment of biological test systems, the inspector should check that:\ntest systems are as specified in study plans,\ntest systems are adequately and, if necessary and appropriate, uniquely identified throughout the study, and that records exist regarding receipt of the test systems and document fully the number of test systems received, used, replaced or discarded,\nhousing or containers of test systems are properly identified with all the necessary information,\nthere is an adequate separation of studies being conducted on the same animal species (or the same biological test systems) but with different substances,\nthere is an adequate separation of animal species (and other biological test systems) either in space or in time,\nthe biological test system environment is as specified in the study plan or in SOPs for aspects such as temperature, or light/dark cycles,\nthe recording of the receipt, handling, housing or containment, care and health evaluation is appropriate to the test systems,\nwritten records are kept of examination, quarantine, morbidity, mortality, behaviour, diagnosis and treatment of animal and plant test systems or other similar aspects as appropriate to each biological test system,\nthere are provisions for the appropriate disposal of test systems at the end of tests.",
  "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/2004/9/annex/I/part/B/division/13",
    "retrieved_at": "2026-11-01T15:22:51.196773+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."
}