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We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.

Most Recent Questions and Answers

I recognize that consumer help seeking campaigns cannot disclose the manufacturer's name. In the event of a DTC disease awareness website, that is seeking to allow users to opt in to receive future communications (all unbranded, disease related in nature), we're challenged by CASL regulations which appear to conflict with Health Canada's guidance. CASL regulations indicate the name of the sender must be included. If the sender of the communication is indeed the manufacturer, is the manufacturer's name, allowed for inclusion in the website copy in this circumstance, presumably with minimal prominence in order to solely meet CASL guidance? Or, can you provide examples, guidance, or a recommendation on how a manufacturer may meet CASL and Health Canada guidance in this situation? Thank you.

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Hello PAAB! Can sales representatives distribute a tool that was approved by PAAB as DTC to physicians to provide to potential patients? Would this tool need to be re-submitted through PAAB as unbranded patient material? Thank you!

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Hi, I wanted some clarity on the rule below. Essentially, we are allowed to use peer reviewed resources, etc. to support claims, as long as the claim made references a clinical endpoint already captured in our monograph? Specifically, if my label mentioned confirmed disability worsening, but I also have long term data that discusses confirmed disability improvement (diff metric), I would not be allowed to use this? -- 3.2.2 Literature used to support claims contained in the APS must be consistent with the indications, dosage regimens, and efficacy and safety information contained in the Health Canada TMA.

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If a DTCI Consumer Brochure closes with a 'help-seeking' message, would it still be considered a Consumer Brochure, or would it be reviewed as a Help-Seeking Announcement (or a combination of the two)?

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Is an unbranded conference booth display targeting HCPs, that leverages creative from a help-seeking DTC campaign exempt from review? There is no mention of product or treatment options, just disease info only. However, other APS that are part of the DTC campaign (same branding) do contain mention of treatment options, however in a balanced presentation.

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Hi PAAB. Can you advertise a drug to the general public if it is indicated for a condition/disease not listed in schedule A.

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Code s6.6(i) states that materials independently prepared with industry involvement limited to sponsorship/distribution are exempt from review. Can you confirm if 3rd party influencer/blogger social media posts are therefore exempt from review, if industry involvement is limited to paid sponsorship?

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Just wondering how long it would take to receive a response to a question submitted through Ask PAAB?

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Would the use of a publication for a clinical trial evaluating two different head-to-head treatment comparisons be allowed in promotional materials if only one of the head-to-head comparisons is in alignment with the TMA? More specifically:

  • The comparison of Product A versus Product B is in alignment with the TMA for Product A i.e, a comparison versus another product in the same therapeutic class as Product B is included in the TMA; the primary endpoint in the publication is the same as a secondary endpoint included in the TMA for a pivotal study; same patient population.
  • The comparison of Product A versus Product C is not in alignment with the TMA indication for Product A.
  • Would the comparison of Product A versus Product B be allowed in promotional materials for Product A?
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We are currently embarking on a help seeking announcement for a prescription product. The help seeking message will follow the criteria as outlined in Health Canada's policy, The Distinction Between Advertising and Other Activities. We wish to additionally inform HCP’s of this campaign through promotional systems such as a detail aid to ensure full transparency to the HCP regarding the campaign. • Are we able to identify the help seeking campaign in promotional systems directed to HCPS? • Are we able to include additional promotional product messages in the promotional material? • If not permissible in the same promotional system, are the two allowed in the same sales call?

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Deputy Commissioner  

Patrick Massad
Deputy Commissioner

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Have a great summer and see you in September.