337 - When we have an update on our product monograph, do we need to revise the piece related to the product and resubmit to PAAB right away or we can wait for the PAAB renewal date?


  • Advertising is required to be consistent with the Terms of Market Authorization (TMA) per Food and Drugs Act section 9.1 and PAAB code section 3.1. If the TMA changes such that the advertisment is no longer consistent with it, then the manufacturer must update the advertisment promptly. It is possible for the provided preclearance period to be rendered invalid by factors including TMA updates and market place changes. Please call the PAAB office if you want to discuss your specific situation.