The cycle of vaccine procurement
Prequalification of vaccines
There are two aspects to prequalification to select suppliers and prequalify vaccines for procurement. One is focused on certifying the quality and acceptability of the vaccine product, while the other is concentrated on assuring the commercial and technical reliability of the vaccine supplier. It is important to differentiate between the two processes and to acknowledge that to minimize confusion the phrase "prequalified suppliers" is NOT used in vaccines as the prequalification process is for individual vaccines only.
What is the objective?
Instituting a system of prequalification for vaccines and a supplier selection process will minimise the risk of purchasing inferior products and/or accepting bids from unsuitable sources.
How to prequalify vaccines?
The most optimal method for obtaining a list of acceptable vaccines for use in-country is conducted through the registration and licensing procedures of the country's National Regulatory Authority (NRA).
If a procurement exercise must take place prior to the completion of formal licensing or in the absence of formal licensing, alternative methods may be used. This includes selecting products that are produced and licensed in countries with internationally recognized NRAs, for example or selecting vaccines only from WHO's list of prequalified vaccines for supply to United Nations agencies.
The documents required to determine a vaccine's eligibility for prequalification should include
- Complete product file for each vaccine (obligatory)
- Proof of current vaccine licensing/registration with NRA of purchaser’s country (obligatory)
- Copy of vaccine license/registration issued by recognised, well functioning NRA of exporting country (optional)
- Statement of assured quality obtained from WHO (optional)
- Evidence of pre-qualification, in principle, by WHO for supply to UN agencies (optional)
- Evidence of registration by recognised, fully functioning NRAs of other importing countries (optional)
Note: The Guidelines for preparation of the product summary file for vaccine prequalification is a procedure targeted to countries that are sourcing their vaccines either through UN agencies or directly from manufacturers, using the WHO prequalified list of products, and that wish to ensure that these products are under appropriate regulatory oversight, but that may lack the resources to carry out a regulatory approval procedure.
Related links
- List of National regluatory Authorities (NRAs)
- World Health Organization's list of prequalified vaccines for supply to United Nations agencies
- Guidelines for preparation of the product summary file for vaccine prequalification [pdf 922kb]
Last updated: 9 October 2008