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Questions mises à jour jusqu’au: 4 octobre 2021

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794

For communications of "contextual use of a product name", that doesn't require preclearance, does it have to fall under the 5 criteria identified in section 1.5D of the code or does it simply not have to have a therapeutic claim or a promotional claim. ie. Does the statement "Call XXXXX for samples of product Y" require preclearance. ( as above no indication, no promotional claims, no therapeutic message attached) Thank you.

The above mentioned copy would not require PAAB review. Exemptions apply to the criteria outlined in section 1.5.

793

Hi there. I submitted a question a few weeks ago regarding whether PAAB needed to review market authorization announcements that do not include any statement of the indication, however my question was not answered, so I am asking it again: Under the PAAB code, it is clear that under section 1.5(D) that a formulary announcement (i.e., now on provincial formulary") does not require PAAB review if it is not linked to a therapeutic message in any way and does not include a coverage criteria or code. However, it is not clear whether to same principle applies to a market authorization/NOC announcement. Does a message (in an email from a rep to a physician) containing only the message "Health Canada has authorized for sale" required PAAB review, if it is not linked to a therapeutic message? Can such a message include a basic link to the full, unedited Product Monograph (as approved by Health Canada) without PAAB review?

Please see PAAB document Pre-NOC Corporate/Editorial Communications for guidance.

792

We are currently waiting for approval for a new indication. Is there any way to disseminate unbranded disease information concerning this new indication before approval (ex: head office emails, medical emails, banner ads, etc.)?

Please see PAAB document Pre-NOC Corporate/Editorial Communications for guidance.

791

Hi there, I hope you are doing well! I'm wondering if an association/organization such as SOGC writes a letter endorsing a tool if that will suffice as an acceptable reference to support statements made in the piece. For background, our product has two indications but we do not have a study that supports both equally and therefore PAAB has said we cannot discuss both in the context of a patient profile. If the SOGC provides a letter stating that the use of this product for one patient (because of the benefit of both indications) is standard clinical practice would that help in approving the APS?

This appears to be a review case specific question. We suggest reaching out to the reviewer to determine what level of evidence/support would be required to support the copy in questions as it depends on the indication wording and how the patient case is being presented. In general, an association/organization letter will not supersede the Health Canada TMA or evidence requirements.

790

We are creating a clinical trial recruitment piece directed to patients evaluating the use of a marketed product for a new use. The study will evaluate the use of our product in combination with another marketed product and the inclusion criteria include the use of prior agents. To improve patient comprehension of the study and the inclusion criteria, we would like to include the marketed names of the combination product and the prior agents. However, the "Clinical Trial Recruitment" section of the Health Canada policy document "The Distinction Between Advertising and Other Activities" states 'no reference is made to the drug manufacturer's name, or to the name of the drug under investigation.' To clarify, does that mean we cannot include the marketed product name or the ingredient name of any agents in the piece?

Yes.

789

To a currently marketed product, and instead of a "now available" message, the message is " has been granted market authorization for additional indications"? (Again, with or without a link to the updated PM Hi There. I've seen several questions that have circled this issue, but none that have addressed it head on: Is an electronic message to physicians that consists entirely of the message that a product has been granted market authorization (without mentioning the indication or therapeutic category), plus the sender's contact details, exempt from pre-clearance? Please assume the message will be sent by sales reps or commercial head office staff. What if this same message also includes a direct link to the product's unedited product monograph? What if the message relates to a label-extension)

A message of "now granted market authorization" is a claim that requires support and substantiation (authorized for what). This is different than a market access claim of "now available". The inclusion of the indication would automatically prompt at least lowest level fair balance. The same would apply to a label-extension. These messages would not be exempt. Please see Q&A 740.

788

Hello Are branded and help seeking search engine marketing campaigns allowed to run simultaneously if coming from different ad accounts and going to different landing pages?

If the regulations are followed, there would be no cross over between these two campaigns as the branded campaign could not include mention of therapeutic areas and the help seeking could not mention brand or manufacturer. No copy or links would be the same. Given this, yes, they could be run at the same time.

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.

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