{
  "url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-2/division-F/division-2",
  "json_url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-2/division-F/division-2.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/F/division/2",
  "kind": "division",
  "number": "2",
  "heading": "Finished product",
  "text": "A description shall be given of the investigations by which the shelf life, the recommended storage conditions and the specifications at the end of the shelf life proposed by the applicant have been determined.\nThe type of stability studies conducted, protocols used, the analytical procedures used and their validation together with the detailed results shall be presented.\nWhere a finished product requires reconstitution or dilution prior to administration, details of the proposed shelf life and specification for the reconstituted/diluted product are required, supported by relevant stability data.\nIn the case of multi-dose containers, where relevant, stability data shall be presented to justify a shelf life for the product after it has been broached for the first time and an in-use specification shall be defined.\nWhere a finished product is liable to give rise to degradation products, the applicant shall declare these and indicate the identification methods and test procedures.\nThe conclusions shall contain the results of analyses, justifying the proposed shelf life and if appropriate, the in-use shelf life, under the recommended storage conditions and the specifications of the finished product at the end of the shelf life, and in-use shelf life if appropriate, of the finished product under these recommended storage conditions.\nThe maximum acceptable level of individual and total degradation products at the end of shelf life shall be indicated.\nA study of the interaction between product and container shall be submitted wherever the risk of such interaction is regarded as possible, especially where injectable preparations are concerned.\nThe stability commitment with a summary of the protocol shall be provided.",
  "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/F/division/2",
    "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."
}