FAQ n.136739

With reference to GM1 21.A.90C 'Also, when the ICA are completed after the product (or change to the product) was approved, this is considered to be a stand-alone change to the ICA.' Is this to be understood that non-ALS ICA provided at EIS (and even after EIS) should be handled as standalone?

Answer

Indeed, this is correct.

Last updated
04/07/2022

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