{
  "url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-IV/division-2/part-2/division-b",
  "json_url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-IV/division-2/part-2/division-b.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/IV/division/2/part/2/division/b",
  "kind": "division",
  "number": "(b)",
  "heading": "Control of starting materials",
  "text": "The particulars and documents on the starting materials, i.e. all of the materials used including raw materials and intermediates up to the final dilution to be incorporated into the finished homeopathic veterinary medicinal product, accompanying the application shall be supplemented by additional data on the homeopathic stock.\nThe general quality requirements shall apply to all of the starting and raw materials as well as intermediate steps of the manufacturing process up to the final dilution to be incorporated into the finished homeopathic product. Where a toxic component is present, this should be controlled if possible in the final dilution. However, if this is not possible because of the high dilution, the toxic component shall normally be controlled at an earlier stage. Every step of the manufacturing process from the starting materials up to the final dilution to be incorporated into the finished product must be fully described.\nIn case dilutions are involved, these dilution steps shall be done in accordance with the homeopathic manufacturing methods laid down in the relevant monograph of the European Pharmacopoeia or, in absence thereof, in an official pharmacopoeia of a Member State.",
  "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/IV/division/2/part/2/division/b",
    "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."
}