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?
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