{
  "url": "https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-3/division-3.1",
  "json_url": "https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-3/division-3.1.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/3/division/3.1",
  "kind": "division",
  "number": "3.1",
  "heading": "Format and presentation",
  "text": "The general outline of Module 3 is as follows:\nTable of contents\nBody of data\nActive substance\nGeneral Information\nNomenclature\nStructure\nGeneral Properties\nManufacture\nManufacturer(s)\nDescription of Manufacturing Process and Process Controls\nControl of Materials\nControls of Critical Steps and Intermediates\nProcess Validation and/or Evaluation\nManufacturing Process Development\nCharacterisation\nElucidation of Structure and other Characteristics\nImpurities\nControl of Active Substance\nSpecification\nAnalytical Procedures\nValidation of Analytical Procedures\nBatch Analyses\nJustification of Specification\nReference Standards or Materials\nContainer Closure System\nStability\nStability Summary and Conclusions\nPost-approval Stability Protocol and Stability Commitment\nStability Data\nFinished Medicinal Product\nDescription and Composition of the Medicinal Product\nPharmaceutical Development\nComponents of the Medicinal Product\nActive Substance\nExcipients\nMedicinal Product\nFormulation Development\nOverages\nPhysicochemical and Biological Properties\nManufacturing Process Development\nContainer Closure System\nMicrobiological Attributes\nCompatibility\nManufacture\nManufacturer(s)\nBatch Formula\nDescription of Manufacturing Process and Process Controls\nControls of Critical Steps and Intermediates\nProcess Validation and/or Evaluation\nControl of Excipients\nSpecifications\nAnalytical Procedures\nValidation of Analytical Procedures\nJustification of Specifications\nExcipients of Human or Animal Origin\nNovel Excipients\nControl of Finished Medicinal Product\nSpecification(s)\nAnalytical Procedures\nValidation of Analytical Procedures\nBatch Analyses\nCharacterisation of Impurities\nJustification of Specification(s)\nReference Standards or Materials\nContainer Closure System\nStability\nStability Summary and Conclusion\nPost-approval Stability Protocol and Stability Commitment\nStability Data\nAppendices\nFacilities and Equipment (Biological Medicinal Products only)\nAdventitious Agents Safety Evaluation\nExcipients\nEuropean Community Additional Information\nProcess Validation Scheme for the Medicinal Product\nMedical Device\nCertificate(s) of Suitability\nMedicinal products containing or using in the manufacturing process materials of animal and/or human origin (TSE procedure)\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/3/division/3.1",
    "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."
}