{
  "url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-2/division-C/division-1/division-1.4",
  "json_url": "https://openlegislation.uk/eu-directive-2001-82/annex-I/title-I/part-2/division-C/division-1/division-1.4.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/C/division/1/division/1.4",
  "kind": "division",
  "number": "1.4",
  "heading": "Substances of biological origin",
  "text": "Where source materials such as microorganisms, tissues of either plant or animal origin, cells or fluids (including blood) of human or animal origin or biotechnological cell constructs are used in the manufacture of veterinary medicinal products, the origin and history of starting materials shall be described and documented.\nThe description of the starting material shall include the manufacturing strategy, purification/inactivation procedures with their validation and all in-process control procedures designed to ensure the quality, safety and batch to batch consistency of the finished product.\nWhen cell banks are used, the cell characteristics shall be shown to have remained unchanged at the passage level used for the production and beyond.\nSeed materials, cell banks and pools of serum and, whenever possible, the source materials from which they are derived shall be tested for extraneous agents.\nWhen starting materials of animal or human origin are used, the measures used to ensure freedom from potentially pathogenic agents shall be described.\nIf the presence of potentially pathogenic extraneous agents is inevitable, the material shall be used only when further processing ensures their elimination and/or inactivation, and this shall be validated.\nDocumentation shall be supplied to demonstrate that the seed materials, cell seeds, batches of serum and other material originating from animal species relevant for the transmission of TSE comply with the Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products , as well as with the corresponding monograph of the European Pharmacopoeia . Certificates of Suitability issued by the European Directorate for the Quality of Medicines and HealthCare, with reference to the relevant monograph of the European Pharmacopoeia , may be used to demonstrate compliance.",
  "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)."
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ C 24, 28.1.2004, p. 6 ."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2001/82/annex/I/title/I/part/2/division/C/division/1/division/1.4",
    "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."
}