Navigation

    Forum

    • Register
    • Login
    • Search
    • Categories
    • Recent
    • Popular
    • Users
    • Groups

    What constitutes a 2 month extension approval?

    FYI post-approval change/preclearance exemption/what requires review/PAAB scope
    2
    2
    139
    Loading More Posts
    • Oldest to Newest
    • Newest to Oldest
    • Most Votes
    Reply
    • Reply as topic
    Log in to reply
    This topic has been deleted. Only users with topic management privileges can see it.
    • R
      rcolbear last edited by

      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.

      Jennifer Carroll 1 Reply Last reply Reply Quote 0
      • Jennifer Carroll
        Jennifer Carroll @rcolbear last edited by

        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.

        1 Reply Last reply Reply Quote 0
        • First post
          Last post