Explanatory Note to GVP Module VIIGVP（良好药物警戒管理规范）模块VII的注释.pdfVIP

2 March 2020 EMA/670256/2017 Rev. 1 Human Medicines Evaluation Division Explanatory Note to GVP Module VII Since the start of the Periodic Safety Update Report (PSUR) single assessment (PSUSA), the procedure has posed a number of challenges that are specific to the assessment of nationally authorised medicinal products. The following explanatory note to Good Pharmacovigilance Practices (GVP) Module VII aims at addressing the challenges encountered during the two years of running the PSUSA process. Ultimately, the explanatory note will serve as the basis for the update of GVP Module V