Pre-submission form (screening)

Prospective Prequalification Holders who wish to submit a product for prequalification must begin the application process by submitting a complete pre-submission form and additional required documentation. A product manufacturer or licenced reseller should refer to the relevant IMD-PQS performance specification and verification protocol(s) to assess whether their product corresponds to an IMD-PQS product category and whether a pre-submission is warranted.

The prequalification Pre-submission form is available here.

The purpose of the pre-submission stage is to screen potential applications for prequalification to establish whether they correspond to an active IMD-PQS product category, i.e. that answers the needs of national immunization programmes. Pre-submission screening also allows IMD-PQS to identify whether a proposed product is likely to meet the programme's performance, quality and safety criteria. The information in the pre-submission form will assist WHO in determining whether the product is eligible for WHO prequalification assessment.

Pre-submission required documentation

The pre-submission screening process requires applicants to provide the following information and documentation:

• Applicant company information
• Authorised contacts for the applicant
• Product name & manufacturer product reference
• Name and number of the reference IMD-PQS product specification
• Previous product testing information
• Licensing information and documents
• Certification information and documents
• WHO history of product
• Prospective Prequalification Holder declaration

All documents submitted as a part of the application must adhere to file name conventions as described in Annex 2 of the WHO IMD-PQS Guidelines for Prequalification.

Method to submit the pre-submission package

The applicant must submit the pre-submission, using the correct file name conventions, by email to Dr Isaac Gobina (gobinai@who.int) and Paul Mallins (mallinsp@who.int), copying pqsinfo@who.int.

Individual PDF or Word files should not exceed 10 MB in size.

IMD-PQS response times: pre-submission process

The IMD-PQS Secretariat will render a decision on a complete pre-submission package within 30 days.