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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 114 - Does PAAB have any oversight on companies that advertise a system for treating periodontal disease through use of non-proprietary antibiotics among other diagnostic and treatment protocols?
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114 - Does PAAB have any oversight on companies that advertise a system for treating periodontal disease through use of non-proprietary antibiotics among other diagnostic and treatment protocols?

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    We would need more information to answer this. The answer would depend on the following: What is the Federal category of the Terms of Marketing Authorization (TMA) for the medications? Is the promotional material directed to health care professionals (HCPs)? Is the "system" approved by Health Canada as a device? If the promotional material is directed to HCPs, the PAAB reviews the content irrespective of the medication's Federal schedule (i.e. whether the product is a prescription, non-prescription, or a natural health product). If the material is directed to consumers in the waiting room, the PAAB would review the messaging for prescription drugs and schedule D drugs. The PAAB would not review claims about the device itself if "the system" had been approved by Health Canada as a medical device. Please call the PAAB office if you have any questions or require further information for your specific case.

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