ICH Q3D Implementation – Elemental Impurities

Do adjustments resulting from the implementation of ICH Q3D have to be submitted as an application to Swissmedic?

If the active substance is monographed in Ph.Eur./Ph.Helv., no change needs to be submitted. Module 3 can be updated as part of another variation, but only if the risk assessment has shown that Module 3 needs to be changed. For active substances that are not monographed in Ph.Eur., the change must be submitted as a variation subject to approval. The Risk Assessment ICH Q3D must be included.

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