WHO prequalifies vector control products to guide procurement by the United Nations agencies and other international organizations for supply to low-income countries. Additionally, the prequalification outputs and outcomes are utilized by NRAs to facilitate national decisions for marketing authorizations. This procedure facilitates sharing, at the manufacturer’s request, of non-publicly available PQT assessment and inspection reports, and laboratory testing reports, where applicable, with participating NRAs. 

The product submitted for national registration must be the same in all essential features as the prequalified product, and the documents that are being shared must be relevant to the product being proposed for marketing in the local country. The national rules for submission of applications and regulatory fees apply when this procedure is used.  In principle, applicants for national registration can use the same dossier as used during prequalification; however, individual NRAs can agree to the submission of simplified dossiers.

NRAs agreement and CRP forms

Appendix 1A

Appendix 1B

Appendix 3B

Appendix 3C 

Manufacturer`s forms

Appendix 2

Appendix 3A

ePQS –Electronic Prequalification System

Quick contact

prequalreg@who.int

kijoa@who.int