{
  "url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-II/part-1/division-C",
  "json_url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-II/part-1/division-C.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/1/division/C",
  "kind": "division",
  "number": "C",
  "heading": "DETAILED AND CRITICAL SUMMARIES",
  "text": "Each detailed and critical summary referred to in the second subparagraph of Article 12(3) shall be prepared in the light of the state of scientific knowledge at the time of submission of the application. It shall contain an evaluation of the various tests and trials, which constitute the marketing authorisation dossier and shall address all points relevant to the assessment of the quality, safety and efficacy of the immunological veterinary medicinal product. It shall give the detailed results of the tests and trials submitted and precise bibliographic references.\nAll important data shall be summarised in an appendix to the detailed and critical summaries, whenever possible in tabular or graphic form. The detailed and critical summaries shall contain precise cross references to the information contained in the main documentation.\nThe detailed and critical summaries shall be signed and dated, and information about the author's educational background, training and occupational experience shall be attached. The professional relationship of the author with the applicant shall be declared.",
  "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/1/division/C",
    "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."
}