{
  "url": "https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-3/division-3.2/division-3.2.1/division-3.2.1.4",
  "json_url": "https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-3/division-3.2/division-3.2.1/division-3.2.1.4.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/I/division/3/division/3.2/division/3.2.1/division/3.2.1.4",
  "kind": "division",
  "number": "3.2.1.4",
  "heading": "Control of active substance(s)",
  "text": "Detailed information on the specifications used for routine control of active substance(s), justification for the choice of these specifications, methods of analysis and their validation shall be provided.\nThe results of control carried out on individual batches manufactured during development shall be presented.",
  "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)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/I/division/3/division/3.2/division/3.2.1/division/3.2.1.4",
    "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."
}