Reporting of annual safety reports, serious adverse reactions and serious violations for clinical trials conducted under the Clinical Trials Regulation (Regulation EU No 536/2014) must be done through CTIS.
For guidance, see link: Reporting safety information on clinical trials | European Medicines Agency (europa.eu). Note that DSUR can replace the annual safety report.
Reporting of SUSARs for clinical trials conducted under the Clinical Trials Regulation (Regulation EU No 536/2014) must be done through the EudraVigilance database.
Please note that no separate reporting to VMK is required.