EN PL

EMA: National-competent-authority requirements for periodic-safety-update-report submission during the transitional period

24.05.2012
This document aims at making publicly available the submission requirements of all Member States as regard Periodic Safety Update Reports (PSURs) during the transitional period, starting from July 2012 until 12 months after the functionalities of the PSUR repository have been established and announced by the EMA.