Division 3.1 Format and presentationF1

United Kingdom

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

Annotations

Textual amendments

F1: 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).