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Dossier Submission Window Closes Soon

(Last Updated On: May 26, 2023)


This is to inform all stakeholders that submission of product dossiers for new applications will close as soon as we have five hundred and forty (540) submitted dossiers. This number represents the maximum that can be handled within a reasonable time frame vis a vis the number of assessors.

We will reopen the window as soon as we conclude reviews of the dossiers received during this window period or the number substantially reduces to less than One Hundred (100) which we are projecting will happen in the next 2 to 3 months.

Please note that we will continue to receive responses to queries raised after the window closes. However, you are reminded that there will be a maximum of two (2) responses (per dossier) to queries raised (for dossiers under screening) and all dossiers failing to meet requirements after the second screening (i.e., initial submission and 2 responses) can only be resubmitted as new in the next window.


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