ANNEX IISupplementary provisions
ANNEX II Format of the electronic periodic safety update reports The periodic safety update report shall consist of the following modules: Part I Title page including signature Part II Executive Summary Part III Table of contents 1. Introduction 2. Worldwide marketing authorisation status 3. Actions taken in the reporting interval for safety reasons 4. Changes to reference safety information 5. Estimated exposure and use patterns 5.1. Cumulative subject exposure in clinical trials 5.2. Cumulative and interval patient exposure from marketing experience 6. Data in summary tabulations 6.1. Reference information 6.2. Cumulative summary tabulations of serious adverse events from clinical trials 6.3. Cumulative and interval summary tabulations from post-marketing data sources 7. Summaries of significant findings from clinical trials during the reporting interval 7.1. Completed clinical trials 7.2. Ongoing clinical trials 7.3. Long-term follow-up 7.4. Other therapeutic use of medicinal product 7.5. New safety data related to fixed combination therapies 8. Findings from non-interventional studies 9. Information from other clinical trials and sources 10. Non-clinical data 11. Literature 12. Other periodic reports 13. Lack of efficacy in controlled clinical trials 14. Late-breaking information 15. Overview on signals: New, ongoing or closed 16. Signal and risk evaluation 16.1. Summaries of safety concerns 16.2. Signal evaluation 16.3. Evaluation of risks and new information 16.4. Characterisation of risks 16.5. Effectiveness of risk minimisation (if applicable) 17. Benefit evaluation 17.1. Important baseline efficacy and effectiveness information 17.2. Newly identified information on efficacy and effectiveness 17.3. Characterisation of benefits 18. Integrated benefit-risk analysis for authorised indications 18.1. Benefit-risk context — Medical need and important alternatives 18.2. Benefit-risk analysis evaluation 19. Conclusions and actions 20. Appendices to the periodic safety update report