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Questions mises à jour jusqu’au: 30 avril 2021

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787

Hi, when Patrick Massad started as the Commissioner, he mentioned at a conference that PAAB will be able to approve/comment for websites projects using a wireframe / blueprint tool provided by agencies, removing the need to comment on pdf and thus making it easier and quicker for everyone to share and implement comments. Has this be enabled or we still have to submit pdf file of website pages?

The PAAB has been exploring ways to streamline the preclearance process. What Patrick was referring to, at that conference, was ongoing research into alternative ways of addressing our need for website screenshots at the layout stage of review. To be clear, the initial review would still be on a copydeck (i.e., the reviews would still take place over PDF).

In the past couple of years, we looked at several automated website scraping tools. None are accurate enough, at this time, to replace the need to screenshots. However, progress appears to be occurring quickly in this space. This is something we intend to revisiting annually. We are also open to testing web scraping tools or other solutions that our clients have come across. Please feel free to post them on the PAAB forum for discussion: forum.paab.ca

In the meantime, we are building eFiles improvements described in the APP service. Additional information about this can be found at http://www.paab.ca/resources/accelerated-preclearance-pathway-app/.

786

Hi, would the following be exempt or require review? a sheet with brand logo, a shot of the pills and a callout « visit www.brand.ca » no claims, and the website is paab approved and gated. thanks for the insight.

If the intent is for the ad to be in the consumer space, it should be submitted to ensure that the entirety of the ad, URL and website landing page, do not exceed consumer regulations.

If the intent is for this to be an ad in an HCP gated space, we suggest submitting for an exemption request so that we may assess the linkage to ensure that it does not go beyond the regulations (implied or direct claims).

785

With regard to fair balance requirement (section 2.4), would a Schedule 2 drug (behind the counter) be considered a ‘self-care’ product?

For the purposes of the code, self-care products includes over the counter, natural health, and homeopathic products. Note that it does not include ethical drugs or schedule D drugs.

784

When constructing Fair Balance, under « Other relevant warnings & precautions, » are we required to include caution in use within certain patient populations where no/limited safety or efficacy data are available? In this situation, patients with certain medical conditions were excluded from the clinical trials, as is standard with other brands in the category.

When it comes to product specific questions, it is best to speak to the reviewer as they will be familiar with the brand and therapeutic area, and there may be other considerations within the TMA that determine if it is required. As a general rule of thumb, this type of statement from the warnings and precautions section would be required if implications/consequences are conveyed such as « not recommended » or « lower the dose ».

783

Hello, I am the author of the Clinical Guide to Probiotic Products Available in Canada (and In the US). This is a resource independently reviewed by a group of experts in the field and published annually online and in print. Our project is supported by the unrestricted educational grant provided by the Alliance for Education in Probiotics, a group comprised of industry members. The Guide is designed as a practical tool to assist health care professionals when recommending evidence =based probiotics to their patients. My question is if this kind of product would be subject to PAAB review? I would appreciate any information you provide. Thank you!

Independent third party publications do not fall within the scope of PAAB. Content taken from the publication, or distribution activities by a manufacturer may render the activity advertising. This would not fall within the purview of the publications responsibilities. If the publication supports advertising content throughout, the advertising content may be subject to PAAB review. See PAAB resource: Guidance on which HCP materials require PAAB Review for additional information.

782

We have a product with a complex indication, requiring previous treatments, biomarkers, etc. We would like to create an algorithm that depicts the approved indication within a diagnostic/treatment framework. Can we utilize Guideline pathways (not recommendations) in order to put the indication in a larger clinical context? For example, we would depict the entire Guideline pathways for all possibilities, but only highlight/emphasize the approved indication portions leading to our product use.

Guideline recommendations and pathways, must be consistent with the TMA for the brands mentioned. When a treatment pathway or algorithm contains content which exceeds the TMA copy, it can be rendered unacceptable in advertising.

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