According to the PAAB guidance on Promotional Monographs, a product monograph whose only modification is the non-selective addition of tabs for each heading throughout the product monograph would not require PAAB review. Are we still required to refer to it on the cover as a Promotional or Clinical Monograph if we are only adding in tabs to assist with navigation? And would colouring the tabs with brand colours (one colour for Part I, one colour for Part II, one colour for part III) make it subject to review?
And if PAAB review is not required due to modifications being limited to the addition of tabs, should the Health Canada issued control number still be removed? The guidance suggests, if we are interpreting it correctly, that regardless of whether it requires PAAB review, only the Health Canada approved document should have the control number on it. Can you confirm?
One last question on this, I am also assuming, if only tabs are being added, that fair balance is not required on the back cover? Please confirm.
Jennifer Carroll last edited by
You are correct that the non-selective addition of tabs for each heading throughout the product monograph, would not require submission to PAAB. The addition of branding colours to those tabs, in the manner described in your question, would not cause the document to require PAAB review. Any further modification may require the submission.
We recommend naming the document a Promotional/Clinical Monograph as it would appear from your description that the control number should be removed.
Modification limited to the addition of non-selective tabs, would not prompt the inclusion of fair balance. Note that changing the cover (beyond the control number removal) such as adding branding colours, elements, logos, would prompt review.