Three different fees will be due over the lifetime of a WHO IMD-PQS prequalified product:

1. Prequalification application evaluation fee
2. Laboratory testing fees
3. Annual Review of WHO IMD-PQS prequalified products

Inspections of a Prequalification Holder's manufacturing site may, in some cases, be required as a part of post-prequalification obligations. In such cases, inspections fees will be due on a cost recovery basis.

Prequalification application evaluation fee

WHO levies a non-refundable, cost-recovery fee for the evaluation of prequalification application dossiers. Application evaluation fees are set per category of product.

WHO will invoice the applicant once the product application has been submitted via the WHO ePQS portal and has been accepted for evaluation. Payment should be made within 30 days of receipt of the invoice from WHO. Evaluation of the product dossier will NOT begin until the fee has been paid in full, in US Dollars, and once WHO has received a confirmation of payment.*

In some cases, IMD-PQS may request applicants to provide production-run product examples ("samples" that are NOT prototypes of models of the product) as a part of the application dossier submission. In such cases the applicant is responsible for bearing the cost of the production-run products provided, and of their shipping.

Please refer to the table below for the cost of prequalification evaluation per IMD-PQS category of product.

*Effective as of 1st January 2024

Laboratory testing fees

IMD-PQS will, in most cases, request the applicant to send the required production-run products ("samples" that are NOT prototypes or models of the product) to one of the WHO-accredited testing laboratories, for evaluation against the relevant IMD-PQS Verification Protocol. The applicant will be required to pay for laboratory testing; it is NOT covered by the IMD-PQS application evaluation fee. Laboratory fees vary.

Annual Review fees

Prequalification Holders are also charged a fee for the annual review of IMD-PQS prequalified products. Fees are due for EACH product submitted for annual review, in order to maintain prequalified status for the following 12 months.

WHO will invoice the annual product review fees to the Prequalification Holder by 31 March each year, for each prequalified product that was listed in the IMD-PQS Product Catalogue up to the 31 December of the previous year. Payment should be made within 30 days of receipt of the invoice from WHO. Evaluation of the product's Annual Review submission will NOT begin until the fee has been paid in full, in US Dollars, and once WHO has received a confirmation of payment.*

Please refer to the table below for the cost of the Annual Review per IMD-PQS category of product.

* Effective as of 1st January 2024

Inspections fees

In some cases, inspections may be carried out in connection with an IMD-PQS prequalification application, or carried out in close collaboration with the Prequalification Unit's (PQTs) Inspection Services Team.

Although not considered a "fee", inspections are conducted on a full "real cost recovery" basis (the Prequalification Holder is required to reimburse the cost of the inspection).

Table of prequalification application dossier evaluation and Annual Review fees