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9 - If we put a BRC regarding a patient program regarding our product in the product package, do we have to send the patient program for PAAB review?
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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You should check with Health Canada regarding "labeling" requirements when you add information to the product package or inside the package. Some companies choose to send these BRC's to Health Canada as labeling. If Health Canada accepts them, they are exempt from PAAB review. If not, it would usually be a promotional item subject to PAAB review. You can check with us. Remember federal labeling requirements apply to sample packaging.
