|PSUR work sharing project details|
|Written by Eva Zubrová|
Main goal of PSUR work sharing project is to increase efectivity and performance of work performed by industry (preparation of reports) and competent authorities (assessment of PSURs). the project is based on voluntary cooperation between industry and competent authorities. For industry the project brings advantage of one PSUR each three years valid in all countries where the product is licenced. The project brings further benefits:
Pilot phase of the project is focused on chemically synthetised substances and vaccines authorised by national procedure, MRP or DCP and doesnt include herbals, homeopatics or blood products. List of involved active substances including proposed EU Birth date, EU Data lock point and responsible Member State (P-RMS) are published on HMA web page: http://www.hma.eu/236.html#c2001. Also more detailed information on this project are published on this web page.
|Last Updated on Sunday, 26 July 2009 09:36|