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

− confirmation that the vaccine meets WHO recommendations;
− stability data to ensure that the vaccine meets the needs of immunization
programmes in developing countries (particularly those with weak cold-
chain systems), and assignment of a VVM category;
− clinical data to ensure that the vaccine is suitable for the target population;
− recommended immunization schedules to ensure compatibility with those
of national immunization programmes;
− suitability of samples, labels, inserts and packaging to meet the UN
agencies’ tender requirements;
− packaging for international shipment and its validation.
The applicant must provide WHO with a copy of the file submitted to the NRA and
relevant sections of the PSF to cover information required in the items listed above.
An NRA that does not require renewal of the licence on a regular basis should have an
alternative mechanism in place to conduct ongoing monitoring of the quality, safety
and efficacy of the vaccines over which it exercises regulatory oversight. Updated
information on these vaccines should be conveyed to WHO by the NRA at defined
intervals. This information may be used in the reassessment procedure.
Review of NRA testing results and their trend, if applicable, instead of
independently testing consistency of final product characteristics
Vaccines submitted for the initial evaluation for prequalification are categorized by
WHO into one of the four categories described in Appendix 3. Vaccines that meet the
criteria described under categories I to III of the table in Appendix 3 may be evaluated
by applying the streamlined procedure.
In this case, WHO will recognize the lot release testing performed by the selected
NRA/NCL responsible for the regulatory oversight of the candidate vaccine. WHO
will review the available information (e.g. testing results, raw data, trends if
applicable, and control charts). On the basis of the information provided by the
NRA/NCL responsible for the lot release and testing of the vaccine submitted for
prequalification, WHO will consider whether additional independent testing by
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