WHO sample product dossiers illustrate the type of evidence that must be submitted by a manufacturer ― when seeking WHO prequalification ― in order to demonstrate that the product is of acceptable quality, is safe and performs optimally when used (as intended by the manufacturer).

Three sample dossiers are currently available:

• Sample product dossier for a qualitative nucleic acid-based testing technology for HIV-1 and HIV-2
• Sample product dossier for a quantitative nucleic acid-based testing technology to measure HIV-1 RNA
• Sample product dossier for WHO prequalification: Simu POC CD4 System: THE Manufacturing Company^®