Prequalification of Diagnostics Dossier Review
The product dossier is reviewed with the purpose of gaining an understanding of the product and how it performs; gaining an understanding of the product manufacturing process; determining if the product is suitable for WHO Member States; determining if the product is ready for a laboratory evaluation and site inspection.
If the dossier is not complete, the manufacturer will be requested to submit additional information within a specified time period. Once a dossier is accepted, the prequalification will proceed to the laboratory evaluation and the manufacturing site inspection.