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What is CMDh Classification of Variations about?

This document provides a summary of proposed changes to classification guidelines according to Article 5 of Commission Regulation (EC) No 1234/2008. It lists various changes classified as type IA, IB or II variations. For example, it indicates that a change in storage conditions of a reference standard would be a type IB variation, while deletion of a manufacturing process would be a type IA variation. It also notes that changes to testing frequency of excipients should be removed from the approved dossier

Author

Aissa

Language

EN