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673 - A company has a product approved in the US. They have a booth at a Canadian convention. Can the company distribute product specific materials in the 'international' section of the booth as long they are in line with FDA approved label? If so, do these materials need to be reviewed/approved by PAAB too?

FYI post-approval change/preclearance exemption/what requires review/PAAB scope

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Jennifer Carroll

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If this is an international conference, the material is not created by the Canadian subsidiary, and all other requirements outlined in response to question 520 are met, this piece would not require PAAB review.
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