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@vt
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PAAB Notice
The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
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Recent Best Controversial

  • 520 - Health Canada's policy "The Distinction Between Advertising and Other Activities" states that materials emanating from a parent company presented during an International conference would not require PAAB review, provided that they are only used within the confines of the conference and are prominently identified as "not being authorized for sale in Canada". However, when a product presented in a promotional booth is approved in the US and in Canada as well, if: - all the material clearly specifies that all the information comes from the US labelling/Marketing Authorization, and - the target audience is from the US and not from Canada, even though some Canadian HCPs could be attending, will this be still considered as promotional activity in Canada and require a pre-clearance form PAAB?
    V vt

    @jennifer-carroll

    The updated Health Canada Policy Document "Guidance on distinction between advertising and other activities for health products" no longer includes the above 4 criteria for International Conferences held in Canada, but instead includes the following two elements that may render these events promotional:
    "• display of a drug product prior to market authorization in Canada is not prominently identified as not being
    authorized for sale in Canada
    • there are actions intended to target the Canadian general public directly or indirectly"

    I was hoping you could help provide some clarity as to how we can ensure the materials we are presenting at an International conference held in Canada are not subject to the Canadian advertising regulations (and thus falls outside of PAAB's scope). Do we still ensure the same 4 criteria are ALL followed? Or are there any additional considerations/changes based on the updated guidance document?

    Thanks in advance!

    International Conferences

  • Guidance for making a #1 dispensed claim
    V vt

    @jennifer-carroll

    I had a follow-up question regarding the 2 requirements needed to support a “#1 dispensed” claim:

    What is the minimum amount of time that a competitor product in the same category needs to be available in Canada (i.e., NOC received) before a “#1 dispensed” claim would be considered acceptable? (Assuming all other requirements as per the Guidance document were met).

    Would it be acceptable to make such a claim if all other product(s) in the same category received NOC less than 12 months ago?

    Thank you!

    Claims & Support/References for Claims
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