{
  "url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-3/division-A/chapter-I",
  "json_url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-3/division-A/chapter-I.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",
  "kind": "division",
  "number": "CHAPTER I:",
  "heading": "PERFORMANCE OF TESTS",
  "text": "The safety documentation shall show:\n(a) the potential toxicity of the veterinary medicinal product and any dangerous or undesirable effects which may occur under the proposed conditions of use in animals; these should be evaluated in relation to the severity of the pathological condition concerned;\n(b) the potential harmful effects to man of residues of the veterinary medicinal product or substance in foodstuffs obtained from treated animals and what difficulties these residues may create in the industrial processing of foodstuffs;\n(c) the potential risks which may result from the exposure of human beings to the veterinary medicinal product, for example during its administration to the animal;\n(d) the potential risks for the environment resulting from the use of the veterinary medicinal product.\nAll results shall be reliable and valid generally. Whenever appropriate, mathematical and statistical procedures shall be used in designing the experimental methods and in evaluating the results. Additionally, information shall be provided regarding the therapeutic potential of the product and about the hazards connected with its use.\nIn some cases it may be necessary to test the metabolites of the parent compound where these represent the residues of concern.\nAn excipient used in the pharmaceutical field for the first time shall be treated like an active substance.",
  "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",
    "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."
}