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484 - What happens when a piece which contains information on multiple drugs is already approved by PAAB but then a product monograph update comes out for one or more of the drugs. Does this require revision and re-submission or is the piece still valid for the duration of the approval period?
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The manufacturer is required to assess whether the monograph change impacts the piece in any way. If so, the piece should be promptly updated and submitted to the PAAB for review. If not, no action is required. If unsure, submit a written opinion to the PAAB (see fee schedule on our website). As stated in Q&A # 337, all product 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 advertisement is no longer consistent with it, then the manufacturer must update the advertisement 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.
