177 - We have a new product under review by Health Canada. A part of the approval is the preparation of the Risk Management Plan, which includes a slide deck for HCPs outlining the safety issues with the medication. Should this slide deck be PAAB approved? if yes, how do we go about this, given that PM is not yet approved?
-
Updated October 19, 2015. Risk management tools should be submitted for PAAB review even when they have been approved by Health Canada. Health Canada has requested that risk management tools (whether targeted to HCPs or provided to patients through HCPs) be reviewed by PAAB. In those instances in which Health Canada has reviewed and approved the pieces, their review focuses on scientific accuracy of the content. Health Canada has therefore 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.
