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,
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.
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.