Forum

Hello @Manufacturer and @Agency PAAB would like to proactively inform our clients that messages of “Made in Canada” and “Product of Canada” can be submitted as FYIs when specified conditions are met. To learn more about the details and a reminder on the FYI process, please visit the PAAB resource page “Product of Canada” and “Made in Canada”. If you have any clarifying questions or comments, we invite you to post them below. Thank you.

Welcome to your brand new NodeBB forum! This is what a topic and post looks like. As an administrator, you can edit the post's title and content. To customise your forum, go to the Administrator Control Panel. You can modify all aspects of your forum there, including installation of third-party plugins. Additional Resources NodeBB Documentation Community Support Forum Project repository

Hi @sonalip9 It’s an interesting question and at face value might seem rational to think an expiry is illogical. However, the regulatory landscape for pharmaceutical advertising direct-to-consumers is more complex than “name, price, quantity”. There are linkages to consider, the totality of marketing campaigns which change over time as well as continuously updated rulings from Health Canada on what is deemed to align with federal regulations. It may not be possible for companies to be aware of all review rulings and understand if they impact their DTCA campaigns. The expiry date encourages companies to stay proactive about regulatory compliance and reassessment to occur in the context of the current market and regulatory environment, not the market of 1, 2 or 3 years past. If the concern is the cost and effort associated with maintaining a file’s acceptance status, we encourage you to utilize the new Renewals Management Dashboard. It was designed to help streamline your renewal submissions and track upcoming renewals. When a renewal is submitted 6 weeks or more in advance of the prior eFile’s expiry, it may be eligible for the early renewal discount, which is 50% off the associated full fee. Rest assured, if you renew early your new acceptance period for the new file will not begin until the end of the prior file’s acceptance period. You can learn more about the Renewals Management Dashboard here.

Good Morning @Manufacturer and @Agency Hope everyone is staying warm and enjoying the ️. The PAAB Quarterly Tag and CEI Reports have been updated to contain data for Q4. See the Tag report here and the CEI report here. The Forum Quarterly Review for Q4 has also been posted. These wrap up 2024! Thank you for another great year of collaboration and compliance. We hope to continue working with you in 2025 Thank you PAAB

Is patient consent information required to be clearly, visually separated from HCP information on a PSP form? I have seen examples of forms that have been approved where the only "visual separation" is that the patient information is in a separate box labelled "patient consent" but there is no different in colour, for example, versus the HCP information, whereas on other approved forms, the patient box is in a different colour than the HCP information. Would that be sufficient? I've also seen a comment that the patient should not be able to see the indication information on the form. Why would this be? The patient has obviously been prescribed the product if they are being enrolled in the program, so why would this be an issue?

Hi @caitlinbyrne When an APS has more than one audience, all regulations for each audience apply. The tool would be reviewed to ensure it meets patient and HCP regulations. Generally the patient regulations are more stringent so we recommend strongly considering them when creating the tool.

Hello @erinmacisaac We’re in the process of building out the 3.0 training which is be similar in format to last year (case based) and directed at a “3.0 level”. If there are topics that you think would be beneficial for a “3.0 level”, please post them below or email them to info@paab.ca and we’ll try to work them into the learning. More details to come.

Hello @tbalzarini Thank you for bringing this to our attention. We will update shortly. In the meantime, the Health Canada “Guidance on Distinction Between Advertising and Other Activities for Health Products” resource should be consulted.

I understand for resizes that are eligible for FYI's the scaling must be directly proportional and cannot result in a change to the layout/flow/content or functionality. Can you comment on if the following would be approvable as I believe it adheres to the above requirements. A small postcard, 5"x 5" is scaled up to 10"x 10". The scaled up pages are then arranged vertically (10" x 20"), matching the order of the PDF submitted to PAAB. This is printed on a poster board. No content is moved around on the pages themselves. Can you also comment on if adding a QR code next to the scaled up postcard, that links to a PDF of the postcard, could be approved as an FYI or would require that a submission?