IX. Appendix 1. Figures on the EU signal management process

Figure IX.2. Notifications and procedural options for emerging safety issues and for signals detected by marketing authorisation holders based on the continuous monitoring of EudraVigilance data

 

Figure IX.3. Confirmation process for standalone signal notifications from marketing authorisation holders

 

Figure IX.4. Confirmation process for signals validated by the Agency or the competent authorities in Member States

 

Figure IX.5. Process for analysis, prioritisation and assessment of signals by the PRAC