Periodic Safety Update Reporting (PSUR) - Synchronisation and Work-sharing

EU Harmonised Birth Dates, Data Lock-in Points & Allocated RMS | xlsx
Current list adopted 22 October 2020

Other documents

Best Practice Guide on handling PSURs in EU PSUR worksharing | pdf
Algorithm | xls

PSUR Worksharing Q&A for Marketing Authorisation Holders, version 8, March 2017 | pdf

Information sheet for Marketing Authorisation Holders: The Core Safety Data Sheet, version dated Feb 2015 | Word

History

Second informative letter to Marketing Authorisation Holders, March 2010 | pdf

First informative letter to Marketing Authorisation Holders, February 2008 | pdf
Date published: September 2008

European Surveillance Strategy (ESS) Concept Paper: PSUR Working-sharing concept for veterinary medicinal products, November 2007  | pdf
Date published: September 2008