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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 164 - I intend to send out a PAAB-approved promotional piece to physicians in a direct mail campaign for an OTC product. I was also considering including a product coupon. The coupon will display the brand name, package shot and discount amount. There will be no claims. Should the coupon be submitted to PAAB, given that it will be distributed in the same envelope as a promotional piece?
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164 - I intend to send out a PAAB-approved promotional piece to physicians in a direct mail campaign for an OTC product. I was also considering including a product coupon. The coupon will display the brand name, package shot and discount amount. There will be no claims. Should the coupon be submitted to PAAB, given that it will be distributed in the same envelope as a promotional piece?

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

    In this scenario, the coupon piece should be precleared if claims are visible on the package shot visual within the APS. Otherwise it is exempt from preclearance. Either way, please inform us of the linkage to the PAAB approved piece. We would need to assess the appropriateness of the linkage. For example, the coupon piece should not accompany an editorial (unbranded APS) as this would inherently brand that piece.

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