Pre-submission meetings

A pre-submission meeting is an essential aspect of assessment for prequalification process, providing an opportunity for advice and guidance before submission of a dossier, and opportunity for the applicant to meet WHO assessors who will be involved in assessing their product.

Pre-submission meetings can be especially helpful to applicants that have no or limited experience with WHO prequalification, and are compulsory for all new applicants to WHO prequalification. However, pre-submission meetings are also useful for applicants experienced with WHO prequalification, to address issues specific to their intended dossier.

A pre-submission meeting can be requested by emailing diagnostics@who.int.