What constitutes a 2 month extension approval?
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Hello. I have an APS which will expire in July. I had a PM change this past February, and another coming in August. Can I request a 2 month extension to allow time for the August PM to be published and all revisions (from both PMs) can be incorporated at the same time? The revisions from the February PM are minimal. Thank you.
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Good Morning @rcolbear
As per “Chapter 4. Post Approval” in the document “Guidance on Submission Process”, a request for extension can be submitted for assessment. An annotated copy of the product monograph with all changes since the previous TMA should be uploaded. The PAAB will make an assessment to see if the changes to the product monograph impact the piece. It is possible for changes deemed to be “minimal” by the sponsor, to still have a meaningful impact on the piece. Upon PAAB assessment, if the piece is still deemed to meet the requirements of the Code, a maximum 2 month extension can be granted.
Note that it is the responsibility of the manufacturer to ensure that they are not using a piece which is inconsistent with PM updates occurring during approval and/or extension periods.
Thank you for the question.
