what specifications apply to the submission as part of the psur synchronisation?
This page is under revision following the new
pharmacovigilance legislation that became effective in July 2012.
For the most current information, please visit www.pharmacovigilance2012.nl .
Within the PSUR synchronisation project there is no joint
assessment, and no CSP is defined as is the case in the PSUR
The same rules as required for
other PSUR submissions, apply to PSUR submissions within the
framework of PSUR synchronisation. The marketing authorisation
holder is requested to indicate in the cover letter that the PSUR
is being submitted as part of the PSUR Synchronisation project.
There are no separate procedure numbers for these submissions like
in the PSUR worksharing.