The concept and use of the IBD for PSURs have not been fully accepted by all regulators.
ADDENDUM REPORTS
The
concept and use of the IBD for PSURs have not been fully accepted by all
regulators. Some require that PSURs are scheduled according to the local
approval date. Moreover, not all companies will have synchronised their renewal
dates by bringing them forward to the IBD in those countries where this is
permissible. To avoid producing additional reports for those countries
perceiving that any report with a DLP more than 60 days before submission is
out of date, CIOMS V recommended the use of an adden-dum report. This is an
update to the most recently completed, scheduled PSUR that is produced when a
regulator requires a safety update outside the usual reporting cycle, and more
than a brief amount of time has elapsed since the DLP of the most recent PSUR.
A brief amount of time here refers to 3 months for a 6-month report, and more
than 6 months for an annual or longer interval report. The addendum report
therefore supplements annual or five yearly reports. CIOMS V proposed that the
addendum report should follow the PSUR format but that it should contain the
minimum of information.
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