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

C. The manufacturer should provide details of GMP inspections (in which the
prequalified product was within the scope of inspection) performed since the
previous annual report.
D. A summary update on implementation of post-prequalification commitments
should be provided by the manufacturer if these are indicated in the approval
letter or reassessment report. These may be, for instance:
− reports of serious adverse events following immunization;
− reports of quality complaints and/or recalls from the field for batches of
the prequalified vaccine;
− notification of any problem/constraint in production or quality control
which might affect the international supply of this vaccine, both in
volume and/or lead times.
E. The Periodic Safety Update Report should be provided (electronic data only).
Following review of the annual report, WHO may request supporting data.
The submission of the first annual report should be the first submission deadline one
year after the date of prequalification, with subsequent submissions each year on the
same date. The manufacturer may provide the latest annual report submitted to the
NRA provided that this contains the relevant information. The established deadlines
for submission of PSFs will apply (31 January, 31 May and 30 September and, for
seasonal influenza vaccines, 1 July and 1 November).
9 Reassessments
Prequalification status is maintained until action is taken by WHO to revoke it.
However, periodic reassessment by WHO is required. The frequency, scope and need
for reassessment will be based on quality risk management principles.
The following aspects will be taken into consideration by WHO:
31