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


Applicable national legal framework/ Reference

Annex X, Art 2 Regulation no. 934/2010)

Additional Information

All SAEs must be fully recorded.