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445 - Further to Question 177, does PAAB exemption also apply to Health Canada-approved patient materials distributed by an HCP in a risk management plan?
FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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Health Canada has requested that risk management tools (whether targeted to HCPs or provided to patients through HCPs) be reviewed by PAAB. We’ve secured confirmation from Health Canada that even in instances in which they reviewed and approved the content, their review is focused on scientific accuracy of the content. They have asked PAAB to review the pieces to ensure that they are not promotional. At the end of our review, PAAB sends the final piece to Health Canada for their records. Question 177 has been updated accordingly. Thanks for directing my eyes to this.
