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PAAB Notice
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.

  • Announcements regarding our community

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    Jennifer CarrollJ
    AI MODEL - Phase I Testing Opt-In Deadline! @Manufacturer the Pharmaceutical Advertising Advisory Board (PAAB) is taking a significant step forward in innovation by launching the first phase of testing of our ground-breaking AI model on live files starting May 1st. On April 1st, in preparation for launch, we sent an eblast to industry announcing the deadline for full opt-in was now set for May 1st. Manufacturers who opt-in after the May 1st deadline will likely need to wait until a sufficient number of additional opt-ins are accumulated. This grouping of late opt-ins is intended to support cost-effectiveness. This initiative marks a major milestone in enhancing the efficiency, consistency, and effectiveness of advertising review processes for our industry. Ensuring that preclearance keeps pace with the speed and quantity of specialization afforded through AI adoption across the industry. If you have not yet reached out to PAAB and want to be among the first to experience the benefits of this exciting new project, please contact info@paab.ca today. @Agency we'll be reaching out shortly for your collaboration on the AI driven augmentation of the submission process. Cheers PAAAB

  • A place to talk about whatever you want

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    Jennifer CarrollJ
    Hey @Supriya This appears to be a specific question about a specific piece. The piece should be submitted for assessment. The forum is for general questions. As an example, a general question here might be “Is the inclusion of an indication statement required in materials directed exclusively to healthcare professionals, where no therapeutic or pharmacologic claims are presented”. The answer to this question would be, that the indication is not required when there are no marketing benefit or therapeutic claims (see Marketing benefit claims: What are they and what level of support do they require?).

  • Got a question? Ask away!

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    Jennifer CarrollJ
    Hey @mhouzer The difference between the Standard 4-day initial review of RMTs and submitting as an ARO-4 is that the subsequent revision turnaround time will be an expedited 2-days rather than the standard 3-days. If you anticipate needing a few rounds of back and forth, this can be a good option to get to your final letter more quickly.

  • Blog posts from individual members

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    Jennifer CarrollJ
    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

  • Have questions about how to use the forum, set up your account, functionality etc.? Ask them here and we'll help you out.

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    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?

  • Do you have questions about particular sections of the PAAB code? Do you have insights on how sections of the code be improved? Do you want to share insights about how related standards are addressed in other jurisdictions? Post here.

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    Hello, Could you please advise whether listing prescription products by product name, strength, and Drug Identification Number (DIN) on this website would be considered a promotional activity? https://lesproduitsduquebec.com/ To encourage the local economy, consumers are looking to buy more and more Quebec products. To promote this growing trend, the Quebec government has supported the creation of Les Produits du Québec, a non-profit organization (NPO). This organization aims to recognize and promote Quebec products.

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    Jennifer CarrollJ
    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.

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    Jennifer CarrollJ
    Good Morning @Constance PAAB would need additional information to make the assessment of the claim proposed above. There are many considerations outside of just the source such as, does it suggest equivalence between products on a per unit basis and what is the intent of the per unit comparison. Given these unknowns, it is difficult to provide a definitive answer in a general space. We suggest submitting the copy for review.