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  1. Home
  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 467 - To whom it may concern, I am looking for some clarification regarding the definition of a “therapeutic message” per section 6.6 (iv) of the code regarding exemptions: “Use of drug name only in a context not linked to therapeutic or promotional messages, other than those listed in any way.” Specifically, we would like to send a fax to pharmacists announcing the approval/availability of a new medication along with details required for their ordering systems (i.e. product code, D.I.N., etc.) Can we simply say the name + the type of medication + disease state? For example: Product X, an SSRI for treating depression, is now available in Canada? This doesn’t link to HOW X treats depression or what an SSRI does...
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.

467 - To whom it may concern, I am looking for some clarification regarding the definition of a “therapeutic message” per section 6.6 (iv) of the code regarding exemptions: “Use of drug name only in a context not linked to therapeutic or promotional messages, other than those listed in any way.” Specifically, we would like to send a fax to pharmacists announcing the approval/availability of a new medication along with details required for their ordering systems (i.e. product code, D.I.N., etc.) Can we simply say the name + the type of medication + disease state? For example: Product X, an SSRI for treating depression, is now available in Canada? This doesn’t link to HOW X treats depression or what an SSRI does...

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  • Jennifer CarrollJ Online
    Jennifer CarrollJ Online
    Jennifer Carroll
    wrote on last edited by
    #1

    Including either “an SSRI” or “depression” (or both) in the product ad described above would trigger the need for preclearance in addition to the indication and lowest level fair balance. In the exempt realm, you could go so far as saying “Product X is now available” + product code & DIN.

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