Prequalification of Diagnostics Letter of Agreement
If the product meets priority criteria for the UN and is ready to proceed further in the process of the WHO prequalification assessment, the manufacturer is notified. Subsequently, a formal letter of agreement is sent by WHO to the manufacturer. This document should be duly signed and sent back to WHO along with a non-refundable prequalification assessment fee of US $12,000, before the process can proceed further. Upon completion of these requirements, the manufacturer will receive an invitation to submit a product dossier