# 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, Division 3.1: Format and presentation

Extent: E+W+S+N.I.

The general outline of Module 3 is as follows:
Table of contents
Body of data
Active substance
General Information
Nomenclature
Structure
General Properties
Manufacture
Manufacturer(s)
Description of Manufacturing Process and Process Controls
Control of Materials
Controls of Critical Steps and Intermediates
Process Validation and/or Evaluation
Manufacturing Process Development
Characterisation
Elucidation of Structure and other Characteristics
Impurities
Control of Active Substance
Specification
Analytical Procedures
Validation of Analytical Procedures
Batch Analyses
Justification of Specification
Reference Standards or Materials
Container Closure System
Stability
Stability Summary and Conclusions
Post-approval Stability Protocol and Stability Commitment
Stability Data
Finished Medicinal Product
Description and Composition of the Medicinal Product
Pharmaceutical Development
Components of the Medicinal Product
Active Substance
Excipients
Medicinal Product
Formulation Development
Overages
Physicochemical and Biological Properties
Manufacturing Process Development
Container Closure System
Microbiological Attributes
Compatibility
Manufacture
Manufacturer(s)
Batch Formula
Description of Manufacturing Process and Process Controls
Controls of Critical Steps and Intermediates
Process Validation and/or Evaluation
Control of Excipients
Specifications
Analytical Procedures
Validation of Analytical Procedures
Justification of Specifications
Excipients of Human or Animal Origin
Novel Excipients
Control of Finished Medicinal Product
Specification(s)
Analytical Procedures
Validation of Analytical Procedures
Batch Analyses
Characterisation of Impurities
Justification of Specification(s)
Reference Standards or Materials
Container Closure System
Stability
Stability Summary and Conclusion
Post-approval Stability Protocol and Stability Commitment
Stability Data
Appendices
Facilities and Equipment (Biological Medicinal Products only)
Adventitious Agents Safety Evaluation
Excipients
European Community Additional Information
Process Validation Scheme for the Medicinal Product
Medical Device
Certificate(s) of Suitability
Medicinal products containing or using in the manufacturing process materials of animal and/or human origin (TSE procedure)
Literature References

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Source: https://www.legislation.gov.uk/eudr/2001/83/annex/I/part/I/division/3/division/3.1 (the official version)
Page: https://openlegislation.uk/eu-directive-2001-83/annex-I/part-I/division-3/division-3.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.