Procedure for assessing the acceptability, in principle, of vaccines ...

with both the WHO requirements and the specifications of the relevant United
Nations agency, and (b) the role of the NRA in certifying this. This letter will be
copied to the manufacturer, the NRA/NCL responsible for lot release, the relevant
WHO regional and country offices, the management of WHO’s IVB department, and
the approved VVM manufacturer.
For AMC eligible products, WHO will send to the GAVI Alliance and the AMCs
Independent Assessment Committee (IAC) a report providing the rationale for
confirming or otherwise that the vaccine meets the target product profile.
The vaccine will be included in the WHO list of prequalified vaccines immediately
after the letter is sent to the United Nations agencies. A page providing the basis for
the acceptance of the prequalification of the specific vaccine will also be included in
the list. The current list may be consulted on the WHO web site (3). In the event of
disagreement between the manufacturer and WHO, a standard operating procedure for
the handling of such disagreements will be followed in order to discuss and resolve
the issue.
The prequalified status of a vaccine is valid until a new reassessment is scheduled by
WHO (see section 9). WHO reserves the right to revoke the prequalification status if
fraud by the manufacturer becomes evident. For details on notification of changes or
introduced variations, see section 7.
Note: Communications, at any time, with the experts involved in a
vaccine evaluation should be conducted through the WHO focal
person in charge of the product.
establishment of AMCs should encourage the development of future generations of vaccines and in particular accelerate
the development and availability of priority new vaccines to developing countries.
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