how does the psur worksharing 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 .

Assessment of PSURs has been harmonised within the EU for some 600 active substances: the PSUR Worksharing. As with PSUR Synchronisation, PSUR submission is synchronised, and the marketing authorisation holder must submit a single PSUR in all member states where the product is authorised. Within the context of the PSUR Worksharing project, this PSUR is assessed by one so-called PSUR Reference Member State (P-RMS). Other member states may provide comments and submit additional information. The procedure is completed by stipulating a Core Safety Profile (=harmonised safety information regarding the active ingredient, CSP).

Procedure numbers have been defined in advance for medicinal products assessed within the PSUR Worksharing. A list of these (approximately 600) active ingredients and assigned DLP, the P-RMS and procedure numbers is available from the HMA website.

Advantages

PSUR Worksharing has advantages for various parties:

• For the marketing authorisation holder: a single PSUR for all marketing authorisations of a substance in the entire EU.
• For the authorities: more efficient use of assessment capacity by letting one member state takes the lead in the assessment.
• For patients, doctors and pharmacists: a single assessment, resulting in unambiguous safety information for the entire EU, on which the Dutch patient leaflet is also based.

The safety information (the CSP) for products with the same active substance will be defined on a European level.