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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 218 - Dear PAAB, We are interested in building a small electronic questionanire that reps will use to ask the doctors some questions about how they feel certain things are a problem in their practice when managing their XXX[disease state] patients? The questionnaire would be unbranded, make no mention of any treatments. Would this be considered PAAB exempt?
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218 - Dear PAAB, We are interested in building a small electronic questionanire that reps will use to ask the doctors some questions about how they feel certain things are a problem in their practice when managing their XXX[disease state] patients? The questionnaire would be unbranded, make no mention of any treatments. Would this be considered PAAB exempt?

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

    Disease information materials which make no mention of treatment by name, class, or category AND are not linked to healthcare product advertising in any way are exempt from PAAB preclearance. If this accurately describes your questionnaire, it would be exempt from PAAB preclearance. Note that "disease information" would not include content alluding to drug treatment even if no product/class/category is mentioned. For example, a questionnaire containing questions like "Have you noticed that your patients have adherence issues with medications that are dosed more than once per day?" would not be exempt from PAAB preclearance. Although not directly related to your question, it should also be noted that market research materials meeting all provisions outlined in chapter 17 of the 2012 Innovative Medicines Canada code do not require PAAB review.

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