Pre-submission meetings

A pre-submission meeting is an essential aspect of the medicines assessment process. Pre-submission meetings provide an opportunity for advice and guidance prior to submission of a medicines dossier, as well as an opportunity for the applicant to meet the PQT medicines (PQTm) assessment team that will be involved with the assessment of their product.

Pre-submission meetings can be especially helpful to applicants that have limited experience with PQTm, and are compulsory for all new applicants to PQTm. However, pre-submission meetings are also useful for applicants experienced with PQTm, to address issues specific to their intended dossier.