{
  "url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-II/part-4/chapter-II/division-C/division-1",
  "json_url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-II/part-4/chapter-II/division-C/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/II/part/4/chapter/II/division/C/division/1",
  "kind": "division",
  "number": "1",
  "heading": null,
  "text": "Unless justified, results from laboratory trials shall be supplemented with data from field trials, using batches representative of the manufacturing process described in the marketing authorisation application. Both safety and efficacy may be investigated in the same field study.",
  "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/II/part/4/chapter/II/division/C/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."
}