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Jennifer Carroll

Hi there,

PAAB can provide approval to APS with links to PAAB acceptable pre-proof articles (see also Code section 3.1.2). However, it is the responsibility of the sponsor to ensure that there are no restrictions to the distribution of the pre-proof article prior to full publication (Code section 3.3).

Maryssa

Hello PAAB,

We are creating responsive search ads. Per this guidance document: https://www.paab.ca/resources/pdfs/Guidance On Submission Process and Format Requirements - EN 07.22.pdf (page 20, section E) it does not sound like we are required to submit the list of keywords for google responsive ads. Can you please confirm if this is the case?

Maryssa

Hi PAAB team,

Will PAAB approve APS that link out to journal articles that are currently pre-proof status or PAAB will require for the final version of the article to be available to approve the APS?

Thanks,
Maryssa

dmauri

We appreciate this being discussed among the PAAB team!

Jennifer Carroll

This post was answered through our office earlier but we will post the answers here as well.

No, only opioids are subject to the Health Canada terms and conditions for advertising.
It is permissible to create promotional materials to HCPs for a controlled drug. However, note that direct to consumer advertising is not permitted.

Jennifer Carroll

This one is tough to answer in a general forum since there are a lot of considerations. First and foremost, the indication is the limitations for the Terms of Market Authorization and therefore sets the context of messaging within advertising. Code section 2.10 applies regardless of perception that terminology has changed. Next, this is a great opportunity for PAAB to remind clients that we do accept endpoints and terminology not listed in the TMA. What we look for is “consistency with the TMA”.

Let’s look at a few examples of where it would not be acceptable.

If the “new terminology” appears to expand the scope of the indication into a broader population than what is outlined in the TMA.
If the “current medical practices” contradict the TMA, such as “use first line” when the TMA states “after failure on class Y”.
The studies based on “newer disease terminology” result in the patient populations or outcomes being broader than those outlined in the Product Monograph.

If a more specific assessment would provide more value, we invite you to submit for an opinion. You may also reach out to admin to set up a short billable consult meeting that would allow discussion of the specific example (more details to come about this service)

Jennifer Carroll

Per Health Canada guidance, PSPs are not a type of additional Risk Minimization Measure/Tool, therefore, there should be no mention of the PSP within the RMT. Participation in the PSP should not be seen as a part of conditions for receiving the drug. Given this, the enrollment form question would be moot. Please, let us know if any new questions come up given the response.

Jennifer Carroll

Hey @dmauri, we haven't forgot about this question. It promoted an internal discussion to find the best solution moving forward. We'll look to get a full response posted some time next week. Thanks.

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