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how does the psur synchronisation project work?

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 .

Under the auspices of the Heads of Medicines Agencies (HMA), the PSUR Working Group for PSUR Synchronisation was created in 2004.

This work group determined a Harmonised Birth Date (EU HBD) and associated Data Lock Point (DLP) for the Periodic Safety Update Reports (PSURs) of some 1800 active substances or combinations of active substances.

Of these (approximately 1800) active substances, approximately 1200 are part of the PSUR Synchronisation project, and approximately 600 of the PSUR Worksharing project.

Within the PSUR Synchronisation project, the DLPs of the (to be) submitted PSURs have been harmonised across all EU countries. These DLPs are based on the EU HBD, rather than on a product-specific (Inter)National Birth Date.

The advantage is that marketing authorisation holders can now submit a single PSUR at the same moment in the whole EU. The PSUR is subsequently assessed by regulatory authorities in all member states where the concerned product is authorised.

A list of these (approximately 1200) active ingredients and assigned DLPs is available from the HMA website.

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