CRED Managing Variations Effectively

Chapter C – Submission requirements

All variation types CTD Module 1 cover letter, application form, reference to prior assessment product information and/or RMP (non)clinical expert statement and CV clinical trials statement: new studies CTD module 2 (non)clinical overview (non)clinical summaries: new studies CTD module 4/5 studies/reports/literature

Extension of indication (additional requirements) orphan aspects (similarity) paediatric aspects User Testing (of package leaflet) Environmental Risk Assessment Risk Management Plan

Introduction to Classification of CMC (Quality) / Clinical / PhV Variations

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