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181 - I know that an on-label reprint distributed in a promotional context (ie by a sales representative) needs to conform with the PAAB Code, but does it need to undergo PAAB review?
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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Dissemination of full, unedited articles from medical or scientific journals whose peer-review was steered by the publisher's editorial board are exempt from PAAB preclearance (PAAB code s1.5). As you've already identified in your question, the advertising regulations would still apply due to the promotional distribution context (i.e. drug reps). Don't hesitate to request a written opinion from PAAB to obtain an independent assessment of whether distribution of the reprint in this manner is aligned with the advertising regulations. Visit www.paab.ca for the fee schedule. Note that materials written or edited by an employee or agent of the pharmaceutical manufacture should be precleared by PAAB.
