Pre-submission Meetings

A pre-submission meeting is an essential component of the medicines assessment process. Pre-submission meetings provide an opportunity for advice and guidance before submission of a medicines dossier, as well as an opportunity for the applicant to meet WHO medicines assessors who will be involved in assessing their product.

Pre-submission meetings can be especially helpful to applicants who 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 request can be made by completing and submitting a pre-submission meeting request form.