{
  "url": "https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-2/division-2.1",
  "json_url": "https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-2/division-2.1.json",
  "legislation": "eudr/2001/83",
  "legislation_title": "Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use",
  "legislation_url": "https://openlegislation.uk/eu-directive-2001-83",
  "path": "annex/I/part/IV/division/2/division/2.1",
  "kind": "division",
  "number": "2.1",
  "heading": "Gene therapy medicinal product",
  "text": "Gene therapy medicinal product means a biological medicinal product which has the following characteristics:\n(a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence;\n(b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.\nGene therapy medicinal products shall not include vaccines against infectious diseases.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Substituted by Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (Text with EEA relevance)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/IV/division/2/division/2.1",
    "retrieved_at": "2026-11-01T15:22:59.083752+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."
}