CRED Managing Variations Effectively

Useful web links

• HMA website >> Human Medicines >> CMDh >> Procedural Guidance >> Variations >> Article 5 Recommendations • CMDh Recommendation for classification of unforeseen variations according to Article 5 of Commission Regulation (EC) 1234/2008 • EMA/CMDh explanatory notes on variation application form • EMA website >> Regulatory >> Human Medicines >>Post-authorisation • Article 5 procedure

Introduction to Classification of CMC (Quality) / Clinical / PhV Variations 97