Before the submission of the complete dossier according to the applicable full assessment pathway WHO guidelines, a pre-submission meeting is required. A pre-submission meeting may also be suitable in some cases for the abridged pathway. The purpose of the meeting is in part to discuss how the applicant will address the requirements of the applicable WHO guidelines.

The applicant should fill out an application for a pre-submission meeting using the online form. Thereafter, the requirement for and suitability of a pre-submission meeting for the intended product will be assessed.

In order to plan for the PSM, the applicant should fill out the quality overall summary (QOS)-BTP and submit it to the Group Team Lead, Medicine Assessment, together with the non-clinical and clinical overall summaries, before the planned pre-submission meeting takes place. The QOS-BTP template is available below, together with other relevant information.

A pre-submission meeting should be scheduled only when the dossier is close to completion, for submission to WHO.

During the pre-submission meeting the applicant should provide brief information on the sites involved in the product manufacturing control and development, including clinical sites/contract research organizations, as well as production experience and robustness, complaints and recalls. The applicant should discuss the most important product's quality characteristics, biological activity, non-clinical and clinical aspects with the inclusion of all clinical trials performed. Furthermore, the applicant should discuss compliance with WHO standards on good manufacturing practice, good clinical practic, good laboratory practice and good distribution practice, and compliance with guidelines on the international packaging and shipping of vaccines, with the inclusion of distribution set-up. Finally, the applicant should discuss adherence of the pharmacovigilance plan, risk management plan and post-marketing safety reports to WHO guidelines.