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Questions mises à jour jusqu’au: 4 octobre 2021

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796

Further to response to question 726, the FDA in the US has issued Guidance on Medical Communications That Are Consistent With the FDA-Required Labeling - Questions and Answers. This approach outlines that information about long-term safety/efficacy of products approved/cleared for chronic use may be considered "consistent with" the FDA-required labelling, if features of the use of the product (indication, population, dosage and administration etc) in the long term study are consistent with the authorized details in labelling. Given this science-based approach, it is not clear to me why PAAB's interpretation would be that this information is not consistent with the TMA in the context of a chronically used product. Can you elaborate on the rationale?

The current approach taken by PAAB is based on consultation with Health Canada based on the duration of time which they have assessed the product for safety within the Canadian population. It is not uncommon for the approach to advertising to be different within other jurisdictions such as the US. Having said that, you are likely aware that we’ve been actively engaging in global benchmarking activities in order to narrow the gap, were possible between Canada and other jurisdictions. We came across the FDA’s CFL guidance through those global benchmarking activities. We are currently looking into ways that this approach (or parts of it initially) can be incorporated into the Canadian regulatory landscape. We’ll soon be preparing a proposal for key stakeholders, which will include Health Canada. Keep in mind that PAAB review practices are not determined unilaterally by PAAB in a bubble.

795

Our corporate logo has recently changed. We would like to swap out our old logo with new one on digital assets that are PAAB approved. Do we need to notify PAAB as an FYI? Does this invalidate the approval somehow? Thank you.

It does not invalidate the pieces. The transition of the corporate logo can be performed without the need for an FYI. Note that this refers to the logo alone. Should taglines be added as part of the logo, this may invalidate some pieces and would require a new review.

794

For communications of "contextual use of a product name", that doesn't require preclearance, does it have to fall under the 5 criteria identified in section 1.5D of the code or does it simply not have to have a therapeutic claim or a promotional claim. ie. Does the statement "Call XXXXX for samples of product Y" require preclearance. ( as above no indication, no promotional claims, no therapeutic message attached) Thank you.

The above mentioned copy would not require PAAB review. Exemptions apply to the criteria outlined in section 1.5.

793

Hi there. I submitted a question a few weeks ago regarding whether PAAB needed to review market authorization announcements that do not include any statement of the indication, however my question was not answered, so I am asking it again: Under the PAAB code, it is clear that under section 1.5(D) that a formulary announcement (i.e., now on provincial formulary") does not require PAAB review if it is not linked to a therapeutic message in any way and does not include a coverage criteria or code. However, it is not clear whether to same principle applies to a market authorization/NOC announcement. Does a message (in an email from a rep to a physician) containing only the message "Health Canada has authorized for sale" required PAAB review, if it is not linked to a therapeutic message? Can such a message include a basic link to the full, unedited Product Monograph (as approved by Health Canada) without PAAB review?

Please see PAAB document Pre-NOC Corporate/Editorial Communications for guidance.

792

We are currently waiting for approval for a new indication. Is there any way to disseminate unbranded disease information concerning this new indication before approval (ex: head office emails, medical emails, banner ads, etc.)?

Please see PAAB document Pre-NOC Corporate/Editorial Communications for guidance.

791

Hi there, I hope you are doing well! I'm wondering if an association/organization such as SOGC writes a letter endorsing a tool if that will suffice as an acceptable reference to support statements made in the piece. For background, our product has two indications but we do not have a study that supports both equally and therefore PAAB has said we cannot discuss both in the context of a patient profile. If the SOGC provides a letter stating that the use of this product for one patient (because of the benefit of both indications) is standard clinical practice would that help in approving the APS?

This appears to be a review case specific question. We suggest reaching out to the reviewer to determine what level of evidence/support would be required to support the copy in questions as it depends on the indication wording and how the patient case is being presented. In general, an association/organization letter will not supersede the Health Canada TMA or evidence requirements.

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