{
  "url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-2/division-E",
  "json_url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-2/division-E.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/2/division/E",
  "kind": "division",
  "number": "E",
  "heading": "TESTS ON THE FINISHED PRODUCT",
  "text": "For the control of the finished product, a batch of a finished product comprises all the units of a pharmaceutical form which are made from the same initial quantity of material and have undergone the same series of manufacturing and/or sterilisation operations or, in the case of a continuous production process, all the units manufactured in a given period of time.\nThe application for marketing authorisation shall list those tests, which are carried out routinely on each batch of finished product. The frequency of the tests which are not carried out routinely shall be stated. Release limits shall be indicated.\nThe dossier shall include particulars relating to control tests on the finished product at release. They shall be submitted in accordance with the following requirements.\nThe provisions of the relevant monographs and general chapters of the European Pharmacopoeia , or failing that, of a Member State, shall be applicable to all products defined therein.\nIf test procedures and limits other than those mentioned in the relevant monographs and general chapters of the European Pharmacopoeia , or failing this, in the pharmacopoeia of a Member State are used, this shall be justified by providing proof that the finished product would, if tested in accordance with those monographs, meet the quality requirements of that pharmacopoeia for the pharmaceutical form concerned.",
  "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/2/division/E",
    "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."
}