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Is there a maximum number of keywords PAAB will accept in one SEM efile submission? For context, we have a media partner who is recommending the purchase of hundreds of keywords and we need to know how we will be able to submit this to PAAB.

Thank you!

Thanks Jennifer!

In the absence of authoritative Canadian consensus guidelines, is there another reference type you can recommend to support which products are recommended to be used first-line, second-line, third-line, etc?

In a disease state that does not have authoritative Canadian consensus guidelines, could a CDA (previously CADTH) Provisional Funding Algorithm be used to support which products are recommended to be used first-line, second-line, third-line, etc. Providing this as an example: https://www.cda-amc.ca/sites/default/files/DRR/2024/PH0047_Multiple_Myeloma.pdf.

Hi PAAB team!

I am hoping you can help me better understand what kinds of messages would qualify as "price" in "name, price, quantity" advertising? Do coverage messages count as "price"?

For example, could a message like this be compliant in a branded DTC ad?
"Did you know there has been a change to national pharma care coverage? Talk to your doctor about Brand Name X."

Thank you!

Hi PAAB,

We're looking for clarification on when we can use brand names in claims when the reference uses the generic name.

It is our understanding based on the previous approval of APS that we can use a brand name in a place in therapy claim when the Canadian guidelines only uses the generic.

E.g.: Copy in APS says "Start with BRAND NAME X - guidelines for the treatment of disease X". This claim is supported by a guideline reference which states that "generic name X" is recommended as first-line therapy for disease X.

Can you clarify if the same applies to combination therapies? For example, BRAND NAME X has an indication in its PM, in combination with generic name Y. Could we have a header in an APS that says "BRAND NAME X + BRAND NAME Y" supported by the combined indication from BRAND NAME X's product monograph?

If the answer to the above bolded question is no, can you kindly clarify why this is different from using a brand name in an APS when the guidelines referenced uses generic?

Hi there!

We are creating a gated, branded website. The pre-gate landing page will have content that is appropriate for a DTC audience. From that pre-gate landing page the user could login as an HCP or a patient. This website will be submitted to PAAB for review.

Our client would like to create banner ads which will exist in the DTC space that drive to the pre-gate landing page of the PAAB-approved website. The ads will target HCPs but appear in DTC spaces online so we understand that the content needs to be appropriate for a DTC audience since we cannot confirm 100% that only HCPs will be exposed to the ads. The content of the ads will simply be "BrandName: Now Approved in Canada. Visit BrandName.ca.".

I have 2 questions based on the above:

1. Do the banner ads need to be submitted to PAAB for review and approval? Or could they be submitted to ASC since they are DTC ads?

2. If we do submit the ads to ASC for review, do we need to notify PAAB of the ASC-approved banners ads that link to the PAAB-approved pre-gate landing page?

Per this newsletter (https://www.paab.ca/resources/targeting-consumer-materials-to-patients-through-healthcare-professionals), we understand that APS which have been approved for consumers by ASC may be subject to PAAB review if an HCP is involved in the decision to disseminate consumer information.

We are hoping you can provide clarity on the limitations of this guidance and provide more details about which situations would be considered HCP involvement in disseminating consumer information.

For example,

1. If an ASC approved poster is hung up in a waiting room, is it now subject to PAAB-review through HCP or patient guidance because HCP's or patients may walk through the waiting room and see it?
2. When a sales rep or other 3rd party leaves ASC approved materials in the waiting room, the physicians are typically aware of what content is being left in their waiting room and likely reading/reviewing it themselves. Are these pieces then subject to PAAB review for HCPs and not just consumers?
3. If an APS is created to make an HCP aware of an ongoing consumer campaign and links out to the consumer website/material, but there is no request for them to share it with their patients, is the attached consumer tool subject to PAAB review as an HCP APS?
4. If a physician hears a radio ad approved for consumers which mentions a website that is approved for consumers and decides to tell their patient about it, does that mean the consumer website should be subject to PAAB review as a patient APS?

Thanks in advance for any clarity you can provide to help us help our clients understand how this guidance can be applied.

A product recently had a product monograph update. We have an expiring APS that only contains lowest level fair balance and none of the balance or content in the piece was impacted by the PM update.

Can we renew the APS with the old PM date confirming the PM update did not impact the APS?

OR do we have to update the PM date and submit as a new submission?

Hi PAAB team!

Looking for some clarification on when the pre-NOC period is considered to have started.

Does the pre-NOC period begin 1 year before expected NOC? 5 years? As soon as the manufacturer is reasonably sure they have a therapy that will eventually be approved for use on the Canadian market?

For context, I am looking to understand at what point a piece that only discusses disease state information (no mention of pharmacotherapy) can be submitted for exemption vs. when it must be submitted for full PAAB review as a pre-NOC editorial piece.

Thank you!

I am wondering if PAAB will allow first and/or only claims regarding dosing regimen (e.g. Drug X: the only treatment for ____ dosed once a month)?

Can you please also clarify the following:

1. I assume this will require a "clinical significance unknown" disclaimer, correct?
2. Will the full dosing regimen need to appear on the APS as well? Or can we say "for full dosing and administration instructions, please see the Product Monograph?
3. What references would be required to support the first/only claim? (Competitor PMs, letter from the manufacturer confirming the claim is true, etc.?)

Thank you!

If a client wants a black & white version of a layout that has been approved by PAAB in full colour, can they make one? Is this black & white layout something that PAAB needs to see?

There would be no other changes to format/size etc.