Notice on New Window for Dossier Submissions

This is to inform all stakeholders that the window for submission of new product dossiers will open on 29^th April 2024.

This submission will be on the NAFDAC Dossier Management System (DMS) Version 2.

All applicants who intend to submit dossiers during this window should note the following.

1. New applicants will need to create their company profiles on the Dossier Management System portal before they can upload their dossiers.
2. Applications of Imported products that are on the Federal Government Import Prohibition List or NAFDAC Ceiling List will be automatically rejected.
3. Applications for Tramadol (all dosage forms) will not be entertained in this window
4. A maximum of two (2) dossiers will be allowed for imported drug products.
5. For a dossier upload to be successful, the QIS, and QOS in MS word and the executed and blank BMRs in pdf must be uploaded.
6. Failure to upload a complete dossier within the window period will lead to automatic rejection.
7. Fast and reliable internet connectivity is essential for a successful upload.
8. For information on API requirements please click to view
   
   

Signed: MANAGEMENT