{
  "url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-3/division-A/chapter-II",
  "json_url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-3/division-A/chapter-II.json",
  "legislation": "eudr/2001/82",
  "legislation_title": "Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products",
  "legislation_url": "https://openlegislation.uk/eu-directive-2001-82",
  "path": "annex/I/title/I/part/3/division/A/chapter/II",
  "kind": "division",
  "number": "CHAPTER II:",
  "heading": "PRESENTATION OF PARTICULARS AND DOCUMENTS",
  "text": "The dossier of safety tests shall include the following:\nan index of all studies included in the dossier,\na statement confirming that all data known by the applicant at the time of submission, whether favourable or unfavourable, are included,\na justification for the omission of any type of study,\nan explanation of the inclusion of an alternative type of study,\na discussion of the contribution that any study that pre-dates studies performed in line with good laboratory practice (GLP) according to Directive 2004/10/EC can make to the overall risk assessment.\nEach study report shall include:\na copy of the study plan (protocol),\na statement of compliance with good laboratory practice, where applicable,\na description of the methods, apparatus and materials used,\na description and justification of the test system,\na description of the results obtained, in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author,\na statistical analysis of the results where appropriate,\na discussion of the results, with comment on observed and no-observed-effect levels, and on any unusual findings,\na detailed description and a thorough discussion of the results of the study of the safety profile of the active substance, and its relevance for the evaluation of potential risks presented by residues to humans.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission Directive 2009/9/EC of 10 February 2009 amending Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to medicinal products for veterinary use (Text with EEA relevance)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/3/division/A/chapter/II",
    "retrieved_at": "2026-11-01T15:22:59.567754+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."
}