Annotated PM when no changes to APS, and no content is referenced
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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!
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Good Morning @MondayMover
In general, what people do is upload the “track changes” version between the original and updated PM. When there are multiple version updates, they provide (upload) the sequential PM track changes PDFs. You do not need to annotate each version of the TMA to the APS, only the most recent PM. In the case described, it sounds like there would be no annotations within the PM as no copy is referenced back to it. If that is the case, it’s likely sufficient to upload the most recent clean PM with an explanation of why the new TMA with annotated changes may not be necessary. Please feel free to reach out to admin for support during the submission process.
