{
  "url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-4/chapter-III/division-1",
  "json_url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-4/chapter-III/division-1.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/4/chapter/III/division/1",
  "kind": "division",
  "number": "1",
  "heading": "Results of pre-clinical trials",
  "text": "Wherever possible, particulars shall be given of the results of:\n(a) tests demonstrating pharmacological actions;\n(b) tests demonstrating the pharmacodynamic mechanisms underlying the therapeutic effect;\n(c) tests demonstrating the main pharmacokinetic profile;\n(d) tests demonstrating target animal safety;\n(e) tests investigating resistance.\nShould unexpected results occur during the course of the tests, these should be detailed.\nAdditionally, the following particulars shall be provided in all pre-clinical studies:\n(a) a summary;\n(b) a detailed experimental protocol giving a description of the methods, apparatus and materials used, details such as species, age, weight, sex, number, breed or strain of animals, identification of animals, dose, route and schedule of administration;\n(c) a statistical analysis of the results, where relevant;\n(d) an objective discussion of the results obtained, leading to conclusions on the efficacy and safety of the veterinary medicinal product.\nTotal or partial omission of any of these data shall be justified.",
  "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/4/chapter/III/division/1",
    "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."
}