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494 - On a STI sample card the Brand name is included along with images of the product. Does this need to be PAAB approved or is it exempt (i.e. no claims are included, no indication statement just product name). Thanks
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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The card itself can be exempt (even though it contains the Brand name) if it contains only transactional information for the pharmacist e.g. insurer, carrier code, and other computer entry instructions related to billing. If there is additional information such as mention (or linkage to) disease/condition OR corporate messages review is required. Recall PAAB reviews corporate messages with product mention under s7.4.
