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414 - Hello PAAB, The approval on one of our APS's is going to expire and we would like to continue using this APS. What is the process to renew the PAAB approval? Do we need to resubmit everything for review even if nothing in the APS has changed? Thanks
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Renewals are treated as new efile submissions. On the submissions page, please check off “renewal” and provide the previous efile number. Your cover letter should provide the previous efile number and confirm that the piece is a straight renewal without change. We will need a clean English and French copydeck as well as the layout. The references are not necessary for a straight renewal, but all submissions require the current TMA and supporting approval letter from Health Canada. If the TMA has been updated since the APS was last approved, please include an annotated version showing all changes. The Reviewer will want to verify that the updates do not affect the APS. Note that the intended date of use should reflect the previous file’s expiry. Turnaround time for first response is the normal 10 business days.
