{
  "url": "https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-3/division-3.3/division-3.3.2/division-3.3.2.5",
  "json_url": "https://openlegislation.uk/eu-directive-2001-83/annex-I/part-IV/division-3/division-3.3/division-3.3.2/division-3.3.2.5.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/3/division/3.3/division/3.3.2/division/3.3.2.5",
  "kind": "division",
  "number": "3.3.2.5",
  "heading": "Developmental studies",
  "text": "The description of the development program shall address the choice of materials and processes. In particular, the integrity of the cell population as in the final formulation shall be discussed.",
  "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/3/division/3.3/division/3.3.2/division/3.3.2.5",
    "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."
}