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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 Worksharing project.

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.

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