{
  "url": "https://openlegislation.uk/eu-directive-2003-85/annex-XIV/division-1",
  "json_url": "https://openlegislation.uk/eu-directive-2003-85/annex-XIV/division-1.json",
  "legislation": "eudr/2003/85",
  "legislation_title": "Council Directive 2003/85/EC of 29 September 2003 on Community measures for the control of foot-and-mouth disease repealing Directive 85/511/EEC and Decisions 89/531/EEC and 91/665/EEC and amending Directive 92/46/EEC (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2003-85",
  "path": "annex/XIV/division/1",
  "kind": "division",
  "number": "1",
  "heading": "Conditions for the supply and storage of the concentrated inactivated antigen supplied to the Community antigen and vaccine bank:",
  "text": "(a) each antigen consists of a single homogeneous batch;\n(b) each batch is split in order to permit it to be stored at two separate geographical sites under the responsibility of the designated premises of the Community antigen and vaccine bank;\n(c) the antigen meets at least the requirements of the European Pharmacopoeia and the relevant provisions of the OIE Manual;\n(d) the principles of Good Manufacturing Practise are maintained throughout the production process and this shall include the storage and finishing of the vaccine reconstituted from the antigens in store;\n(e) if not otherwise specified in the texts referred to in point (c), the antigen is purified to remove non-structural proteins of the foot-and-mouth disease virus. The purification shall at least ensure that the residual content of non-structural proteins in vaccines reconstituted from such antigen does not induce detectable levels of antibody against non-structural proteins in animals which had received one initial and one subsequent booster vaccination.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2003/85/annex/XIV/division/1",
    "retrieved_at": "2026-11-01T15:22:52.569704+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."
}