CASafetyReporting object
Responsible for AE reporting to CA
Manufacturer acting as sponsor
Sponsor must declare reportable events to
National CA
CA(s) of EU&EFTA Member States concerned
Reportable AEs
SAE (Serious Adverse Event)
SAE /SADE must be reported
Immediately (without delay)
National legal framework in place
Yes
Additional Information
All SAEs must be fully recorded.