Pre-submission
Preparing a pre-submission
Applications for WHO Prequalification assessment are accepted through the ePQS portal.
New manufacturers are required to register to access ePQS portal by completing the form available at ePQS login portal.
The manufacturer is required to submit a completed pre-submission form and the supporting documentation in the WHO ePQS portal through the application wizard, to provide summary information about the product, details of the regulatory version and the manufacturer. This information will enable WHO to determine whether the product is eligible for WHO’s prequalification assessment and, if so, the type of assessment (full or abridged) that will be applied. It is also used to determine the regulatory version intended for prequalification and to plan for each of the components of the prequalification assessment process.
Documentation to be submitted
The instructions document “Instructions for the completion of the pre-submission form” provides guidance to the manufacturer when completing the pre-submission form template. The manufacturer must submit a completed pre-submission form and supporting documentation.
Manufacturers must not submit a product dossier together with the pre-submission form. Dossiers that are submitted in the absence of a formal request from WHO will be deleted without prior notice.
Where to submit the documentation
The pre-submission form and the respective attachments must be submitted electronically — as searchable PDF files — to the ePQS portal
WHO schedules a pre-submission meeting with the manufacturer. A pre-submission meeting is compulsory for all applicants who are new to WHO prequalification but is also available to manufacturers who have already submitted products for prequalification. Please refer to the webpage "support to manufacturers".
Timelines for WHO decision on eligibility for WHO’s prequalification assessment
The completed pre-submission form and supporting documentation will be reviewed against the eligibility criteria for IVD prequalification to determine eligibility for prequalification assessment. WHO will inform the manufacturer in writing of its decision as to whether or not the product is eligible for prequalification assessment within 30 days, and if accepted, provide instructions on the next steps to be followed, depending on the type of assessment (full or abridged).