{
  "url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-3/division-B/chapter-II/division-1",
  "json_url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-3/division-B/chapter-II/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/3/division/B/chapter/II/division/1",
  "kind": "division",
  "number": "1",
  "heading": "Identification of the product",
  "text": "An identification of the veterinary medicinal product(s) used in the testing shall be provided, including:\ncomposition,\nthe physical and chemical (potency and purity) test results for the relevant batch(es),\nbatch identification,\nrelationship to the final product,\nspecific activity and radio-purity of labelled substances,\nposition of labelled atoms in the molecule.\nThe dossier of residue tests shall include:\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 GLP can make to the overall risk assessment,\na withdrawal period proposal.\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 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,\nan objective discussion of the results obtained, and proposals concerning the withdrawal periods necessary to ensure that no residues which might constitute a hazard for consumers are present in foodstuffs obtained from treated animals.",
  "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/B/chapter/II/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."
}