EMA: Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report

Periodic safety update reports (PSURs) are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorisation holders at defined time points during the post-authorisation phase. The format of PSURs shall follow the structure described in the IR Article 35. This Module provides guidance on the preparation, submission and assessment of PSURs.