Explanatory Note to GVP Module VII

The explanatory note to Good Pharmacovigilance Practices (GVP) Module VII aims at addressing the challenges encountered during the two years of running the Periodic Safety Update Single Assessment (PSUSA) process. Ultimately, the explanatory note will serve as the basis for the update of GVP Module VII, which will eventually replace it. It should be noted that, as appropriate, points highlighted in this document may also apply to the assessment of centrally authorised products. This note should be read in conjunction with GVP Module VII; where appropriate, references to ICH E2C (R2) are made; it should be used for the preparation of PSURs subject to single assessment.