Spring Intro 2023

TYPE IA/IA IN VARIATIONS

The Organisation for Professionals in Regulatory Affairs

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Type IA Variations: Procedure

 Type IA “Do and tell” ● MAH to implement the change (DO) ● MAH to notify Authorities (TELL)

– ‘Immediately’ (Type IAIN) – Within 12 months (Type IA) ● After 30 Days EMA/RMS will inform MAH about the outcome  Send as single notifications or grouped Type IAs as “annual report” ● Any time after the change but latest 12 months after first IA variation has been implemented  Increased flexibility allows manufacturing to make and implement changes and then notify the authorities  Consider implications on product if agency rejects IA variation after you have implemented the change.

The Organisation for Professionals in Regulatory Affairs

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