83 - Once PAAB approves a patient information brochure, does it ever expire? In other words, can we reprint a brochure that was previously PAAB approved and distributed several years ago? Also, what if the product has a change in ownership - if the brochure was previously approved by the seller of the product, can the buyer of the product use the same content without re-submitting for a new approval? The only change would be the addition of the new owners trademarks and the removal of the previous owners trademarks.
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The PAAB code allows a maximum period of 12 months for PAAB clearance acceptance of all Advertising/promotion Systems (APS) that do not include market share or price claims. If the APS is to be used longer than 12 months then the sponsor should submit a renewal submission request for pre-clearance review. Information about the drug or marketplace conditions may change over time.
