Fees Required in getting WHO Pre-qualification of IVD (WHO-PQ) | WHO-PQ Cost | Lecture-10

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Prequalification Procedures and Fees: In Vitro Diagnostics
This Prequalification Procedures and Fees section is dedicated to enabling potential applicants to determine how, whether and what information they must compile in order to submit an application for WHO prequalification of an in vitro diagnostic (IVD).


Duration of validity of prequalification status
The duration of the validity of the prequalification status of a product is dependent on the manufacturer’s fulfilment, within the applicable deadlines, of its post-qualification obligations and requirements, which include:


Prequalification fees
Prequalification fees are levied to cover part of the costs associated with product dossier screening and review, performance evaluation commissioned by WHO, manufacturing site(s) inspection, review of labelling, dissemination of prequalification information, change assessment and dissemination of change information.

Fees must paid within a defined timeline. Failure to do so will result in cancellation of the assessment application, or change request application, or suspension of prequalification status of the prequalified product, whichever is applicable. Fees are non-refundable.

Payment of prequalification fees does not guarantee that the product will be prequalified and/or that, if prequalified, the product will retain its prequalification status for any minimum duration.

Assessment fee
A prequalification assessment fee is charged to a manufacturer once its application has been determined to be eligible for WHO prequalification assessment. For a product undergoing full assessment, US$ 5000 is charged for dossier screening and US$ 12,000 for product assessment. For a product undergoing abridged assessment the fee is US$ 8000.

Change assessment fee
WHO will review the change documentation submitted by the manufacturer to determine the type and level of assessment required which, in turn, will determine whether the change assessment fee of US$ 3000 will be charged. The change assessment fee is waived in certain cases. WHO does not charge fees for the assessment of administrative changes and for certain abridged reviews. WHO determines the applicability of a waiver on a case-by-case basis.

Annual fee
An annual fee of US$ 4000 is levied for each product listed on the WHO List of Prequalified In Vitro Diagnostics. An invoice for the annual fee will be issued by WHO to the manufacturer on or before 1 October of each year. The annual fee is applicable to all IVDs that, by 1 September of that year, have been listed for 12 months or more. Payment of the annual fee must be made before 30 November of the calendar year in which the invoice is issued.

List of Queries-
What is WHO Prequalification of In Vitro Diagnostics Product ?
What is WHO-PQ IVDs?
What is the benefits of WHO-PQ?
WHO-PQ IVDs kya hota hai ?
WHO-PQ kya hai ?
World Health Organization PQ kya hai?
WHO-PQ Guidelines ?
WHO-PQ Labelling Review
Symbols
Labelling
Prequalified List pf IVD Products
General information – WHO List of Prequalified In Vitro Diagnostic Products
In Vitro Diagnostics Eligible for WHO Prequalification
Eligibility principles
Eligibility criteria
IVD products currently eligible for submission for prequalification
Prequalification Procedures and Fees: In Vitro Diagnostics
Who can participate in WHO prequalification of IVDs?
What are the steps of IVD prequalification?
Full assessment or abridged assessment
What happens when an IVD is prequalified?
Duration of validity of prequalification status
Post-prequalification
Prequalification fees
Prequalification Reports
Public Reports




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