You are here Home Guidance and resources Resources Module 1.8 - Information relating to pharmacovigilance Applicable for applications lodged from 1 July 2017 Last updated 10 July 2017 Listen Print Share LinkedIn (Twitter) Facebook Email Loading... Information in module 1.8 is not expected for OTC medicine applications. Previous Module 1.7 - Compliance with meetings and pre-submission processes Next Module 1.9 - Summary of biopharmaceutic studies