EN PL

EMA: Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies

31.01.2013
From 10 January 2013, marketing authorisation holders have the obligation to comply with the format of the final study report for non-interventional post-authorisation safety studies (PASS), as specified in Art 36 to 38 and Art 40 of the Commission Implementing Regulation (EU) No 520/2012. This document provides guidance for writing the final study report for non-interventional PASS in order to support the consistency of the information provided and facilitate its assessment.