{
  "url": "https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-5/division-5.1",
  "json_url": "https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-5/division-5.1.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/I/division/5/division/5.1",
  "kind": "division",
  "number": "5.1",
  "heading": "Format and Presentation",
  "text": "The general outline of Module 5 is as follows:\nTable of contents for clinical study reports\nTabular listing of all clinical studies\nClinical study reports\nReports of Bio-pharmaceutical Studies\nBio-availability Study Reports\nComparative Bio-availability and Bio-equivalence Study Reports\nIn vitro — In vivo Correlation Study Report\nReports of Bio-analytical and Analytical Methods\nReports of Studies Pertinent to Pharmaco-kinetics Using Human Bio-materials\nPlasma Protein Binding Study Reports\nReports of Hepatic Metabolism and Interaction Studies\nReports of Studies Using Other Human Bio-materials\nReports of Human Pharmaco-kinetic Studies\nHealthy subjects Pharmaco-kinetics and Initial Tolerability Study Reports\nPatient Pharmaco-kinetics and Initial Tolerability Study Reports\nIntrinsic Factor Pharmaco-kinetics Study Reports\nExtrinsic Factor Pharmaco-kinetics Study Reports\nPopulation Pharmaco-kinetics Study Reports\nReports of Human Pharmaco-dynamic Studies\nHealthy Subject Pharmaco-dynamic and Pharmaco-kinetics/Pharmaco-dynamic Study Reports\nPatient Pharmaco-dynamic and Pharmaco-kinetics/Pharmaco-dynamic Studies Study Reports\nReports of Efficacy and Safety Studies\nStudy Reports of Controlled Clinical Studies Pertinent to the Claimed Indication\nStudy Reports of Uncontrolled Clinical Studies\nReports of Analyses of Data from More than One Study including any formal integrated analyses, meta-analyses and bridging analyses\nOther Study Reports\nReports of Post-marketing Experience\nLiterature references",
  "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/5/division/5.1",
    "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."
}