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

Provide an outline of the applicant’s procedures for the collection, onward notification
and assessment of adverse events. Provide a listing of all reported AEFIs for the
vaccine in question in the last five years or since the last WHO reassessment. As far
as is possible from the reports received, applicants should list the type of reaction, lot
number, date and place of immunization, patients’ initials and age and, for
immunization series, the dose number. A judgement of seriousness and whether or not
the event was expected (in the light of the prescribing information) should be
provided where this is possible from the information. An assessment of the
relationship to the vaccine made by a clinician and, where relevant, by the applicant
company or its independent clinical expert, should be included.
Whenever periodic safety updated reports (PSURs) are available, these shall be
submitted. The PSURs should include information following the ICH format from all
geographical areas where the vaccine is used, or the absence of such information
should be defended.
8.3.3 Recently licensed vaccines
In the case of vaccines that have recently been licensed, provide information on any
ongoing phase IV studies or on any active monitoring of the safety profile that is
taking place.
8.3.4 Documentation of serious adverse events
For serious adverse events reported in the last five years, or as long as the vaccine has
been marketed (when shorter than five years), provide the fullest possible description
of each case, including any information there may be on investigations, actions,
patient treatment and outcome. This information should be provided as part of the
PSUR.
Chapter 9: Production and distribution data
9.1 Provide information on the quantity of finished product distributed domestically
and exported in the previous three years. List the different presentations separately,
and indicate whether the list gives the numbers of vials or the numbers of doses
distributed. When the product is a combination vaccine, information should also be
provided on the history of distribution of component vaccine(s), when applicable.
9.2 Provide a list of countries where the product is licensed (marketing authorization)
and supplied.
55