Hello!
I was wondering if there was any guidance on annotated PMs for renewals when the APS being submitted isn't affected by any of the PM changes? We have some materials coming up for renewal soon for a patient support program where the APS has no changes. The PM has had many changes within the year plus since the APS was last approved. The APS materials are only PSP program materials, and don't reference the indication or anything, just the product name and the molecule, and information on how the program works.
Is there any way to just submit the new product monograph, instead of having to create PDFs for annotated changes from such a wide date range/many changes? I understand probably not, just wanted to check!