Spring Intro 2023

Examples for Type IA variations

 Change in the name of active substance (Type IA IN )  Deletion of manufacturing sites  Minor change in the manufacturing process of active substance (not for biologicals/immunologicals though)  Tightening of in-process limits  Change in immediate packaging of finished product (solid form only)

The Organisation for Professionals in Regulatory Affairs

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TYPE IB VARIATIONS

The Organisation for Professionals in Regulatory Affairs

16