WHO requires a separate and complete product application dossier for each product deemed suitable for evaluation. In addition, a separate dossier is required for each new site at which a product is manufactured.
The product application dossier must contain:
- complete details of the manufacturing process
- documented evidence that the product meets the performance and functional requirements detailed in the relevant performance specification
- complete manufacturing certification and licencing.
In addition to the application documentation, manufacturers may be required to test products using one of four laboratory testing procedures and or field-testing; the results of which will be evaluated by PQS.
Once the appropriate product verification or testing has been completed and included in the product application dossier, the dossier will be accepted for review by WHO and will be distributed to the members of the relevant dossier review team. Each application is reviewed independently by a dossier review team.