Periodic safety update reports

Best Practice Guide on (1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU Reference Date is not yet legally binding (March 2017)

CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs (PSUFU) (February 2021) [Track version]

Overview of comments received and responses on “CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs” (April 2018)

Template - PSUR Assessment Report

Template - Lead Member State PSUR Follow-Up assessment report