FAQ
M
Fees are levied for evaluation for prequalification for active pharmaceutical ingredients (APIs) and finished pharmaceutical product (FPPs), and for evaluation of major variations for prequalified FPPs. An annual fee is also levied for each prequalified API or FPP. In some instances, deferred fees may be applied.
In considering an application for prequalification evaluation, manufacturers should also consider the common expenses involved in preparing a product for WHO or other stringent evaluation.
The majority of quality control laboratories (QCLs) that WHO prequalifies are national laboratories or academic institutions, the financial resources of which are often limited. WHO therefore decided not to levy a fee for QCL prequalification.