{
  "url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-3/division-A/chapter-I/division-3/division-3.6",
  "json_url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-3/division-A/chapter-I/division-3/division-3.6.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/I/division/3/division/3.6",
  "kind": "division",
  "number": "3.6",
  "heading": "Carcinogenicity",
  "text": "The decision on whether carcinogenicity testing is required shall take into account the results of genotoxicity tests, structure-activity relationships and the findings in systemic toxicity tests that may be relevant to neoplastic lesions in longer term studies.\nAny known species specificity of the mechanism of toxicity shall be considered, as well as any differences in metabolism between the test species, target animal species, and human beings.\nWhere carcinogenicity testing is necessary, generally a two-year rat study and an 18-month mouse study are required. With appropriate scientific justification, carcinogenicity studies may be carried out in one rodent species, preferably the rat.",
  "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/I/division/3/division/3.6",
    "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."
}