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Hi @Jennifer-Carroll. Our agency recently recognized that while we understand a formal reference list is not required in patient-directed tools, we could not identify the specific section of the PAAB Code that supports this. Could you help clarify where this is addressed?

Hi @mimic909!

If it's properly gated for HCPs, then yes. You might also find this PAAB forum response helpful as well.

@danthony

I kid you not, I was just saying the other day to our team how this would be a really great thing to have (and dreaming about it for much, much longer). Thanks so much for this excellent upgrade!

@jennifer-carroll Hi there! Thank you for the clarification. I'd like to note that your initial reply has been the basis of many successful renewal submissions, whereby only EN layout has been provided by our agency and others for renewal of originally EN+FR efiles. It was very clear that this was the correct approach:
Q: "Does this mean that for renewals, we only need to send in the English layout without English and French copy decks?"
A: "You are correct for straight renewals if the previous file contained a copy correct layout."

This latest reply is a change to this previously clear policy; it may be simpler to delete the original post to prevent confusion if this is the way things will be moving forward.

@jennifer-carroll This is an exciting change! I'm sure we're all wondering why the PAAB is evolving its stance on this subject, which has in the past generally been a no-go zone. Could you provide any context?

@mef It definitely would not be.

Hi PAAB—could you kindly clarify if the below section of the code applies solely to the manufacturer's product or all products mentioned within an APS? Does this vary if the manufacturer opts to include the brand name of another manufacturer's product within an APS, not just its generic name (assume this is permissible due to an acceptable head-to-head trial)?

2.2 In all APS for pharmaceutical products, the brand or trade name, the non-proprietary or generic name and the Federal drug schedule of the product must appear in juxtaposition at least once within advertising copy and must be in good contrast and be legible.

Hi there! I understand there is new a requirement to include a disclaimer when linking to websites that have a consumer-facing landing page from HCP materials (e.g., micetype linked to the site URL that states "The website landing page of drugx.ca is open to the general public." or similar).

Could you help clarify what precipitated this requirement and concern it addresses? Additionally, do URLs that direct HCPs to HCP-only landing pages/content require similar disclaimers?

@kiki

I'm sure that @Jennifer-Carroll will provide a more complete/corrected answer, but in the spirit of getting the conversation going I thought I'd provide a few initial resources/thoughts:

• Our brand would like to create a sticker with an LU code listed and they are willing to put the code criteria also on the sticker.
• • Just a note that if you're opting to include the LU code, you will also have to include the criteria (i.e., that's not optional); see Provincial Formulary Coverage PAAB Guidance.
• The sticker will then be placed on various branded, PAAB approved leave behinds. So a) can this be done?
• • Yes, but sticker placement will have to be assessed for all tools; see PAAB Q&A #516.
• And b) if the criteria is broader than the indication, is that an issue?
• • This will be an issue in the scenario you described, given the criteria would be considered off label. See this post.

@cl This might be helpful: https://forum.paab.ca/topic/2048/email-update-on-cadth-recommendation?_=1620393473878

Hello!

Hoping to verify how PAAB would like the manufacturer to confirm the two requisite points within this guidance (i.e., (1) representatives will be adequately trained on proper use of open text fields; (2) there is an audit-type mechanism in place to monitor and ensure compliance with this directive):

• Is a Med/Reg letter necessary or is a written statement within the initial cover letter/a subsequent response sufficient?
• Is a list of restricted words required in our submission for review?

As always, thank you for your time in advance.

@jennifer-carroll

Hello! Hoping you could clarify what is to be supplied to PAAB to satisfy the following: "The submission of the email template should include detailed information regarding the naming convention for email attachments."

Given you state above that an "exhaustive list would not be required" for all documents to be distributed via the template, but then go on to say that the quoted example "does not provide sufficient information for assessment", it is unclear what PAAB ultimately requires.

Very exciting! It looks as though the forum link you posted for questions is not accessible at this time (states "Access Denied" when clicked).

Hello! Based on the Submission Process PAAB Guidance, updates to the PM during ongoing efile reviews “may incur a new file number and corresponding fee” upon the reviewer’s assessment of the updated PM and its impact on the APS. What threshold is used to determine whether a new efile submission is required?

@Jennifer-Carroll I've solicited feedback from ANTIBODY's Creative Director, Melisa Barrilli, who had the following thoughts to offer on the bilingual logo:

Although we rarely use bilingual logos, they do come in handy. Glad a version was created! The bilingual logo seems to have optimized the space and flows well. Legibility seems excellent for the PAAB/CCPP words. It will be interesting to see how all versions look when applied at their minimum recommended size—there's considerable size variation with the smaller type, so "Reviewed by" may become illegible if used too small.

Hope this is useful!

Love the new look! Is there an approximate roll-out timeline for the new logo?

Hello from our team here at ANTIBODY Healthcare Communications!

The examples provided within this guidance document solely concern relative claims that are positioned as a secondary message (e.g., as a callout). However, based on our previous experiences, our understanding is that there is no restriction in positioning a claim with a relative value as the main message for a page (e.g., as a headline), although we understand that such a claim would now require absolute values to be prominently integrated within it.

Would you be so kind as to confirm that this continues to be the case?