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Forum

J

jd

@jd
Manufacturer
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

  • Disclaimers to be added on materials at international conference
    J jd

    Dear PAAB,

    In the context of an International conference held in Canada,
    the Health Canada Policy Document: The Distinction Between Advertising and Other Activities states that materials must be prominently identified as not being authorized for sale in Canada (or similar disclaimer if the product is authorized for sale but content is based on a different label). In a booth space, assuming all other 3 criteria are met and Canadian HCPs are not targeted but the material is available to all attendees:

    • Would such disclaimers be required to be added onto the booth panels themselves or would a sign in the booth space on an easel suffice?
    • Would such disclaimers be required on all handout materials as well or could a folder with a disclaimer be developed ?
    • Would the disclaimer on the material extend to linked resources/collaterals mentioned in these materials, for example an HCP website ?

    Thank you

    International Conferences

  • International Conference Held In Canada - Confines of the Conference
    J jd

    @jennifer-carroll

    Thank you for your prompt response.

    We apologize for the lack of clarity in our initial question. At an international conference held in Canada, would handouts from a non-Canadian affiliate, with proper disclaimers, distributed at a non-Canadian promotional booth or in door-drops/delegate bags to all attendees (including, but not targeting potential Canadian attendees) still be considered to “only be for use within the confines of the conference” given that those materials would be printed and therefore be taken outside of the conference? We are struggling to understand the meaning of "within the confines of the conference".

    Thank you !

    International Conferences

  • International Conference Held In Canada - Confines of the Conference
    J jd

    Dear PAAB,

    we are trying to get a better understanding of the criteria for International Conferences Held In Canada outlined in the Health Canada Policy Document: The Distinction Between Advertising and Other Activities. We would like clarification on what is meant by ''within the confines of the conference''. Assuming that all the other criteria are met, would any printed material (i.e leave behind) distributed at a non-Canadian promotional booth, room-drops or material included in a delegate bag be aligned with the guidance and not subject to advertising regulations (exempt from PAAB)?  Would such material be considered to be used ''only within the confines of the conference''? If the material was strictly distributed to non-Canadian attendees, would it be acceptable?

    Thank you so much !

    International Conferences

  • Informational Communication to HCPs on DTCI Campaign
    J jd

    Is it possible to send a communication to HCPs to inform them of an ASC-cleared DTCI campaign which includes a help-seeking announcement?
    Would this informational communication to HCPs be subject to PAAB review and is it be possible to mention the manufacturer on this communication?
    Should the communication require PAAB review, would the campaign itself become subject to PAAB review as well?

    DTCA/I, consumer secondary audience

  • Branded Reprint Carrier for Pivotal Trial
    J jd

    Would a branded reprint carrier for a pivotal trial included in the Product Monograph that only features the product name and logo (no claims or data) require PAAB review? Would the indication and fair balance be required? If so, which level of fair balance? Thank you

    FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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