CASafetyReporting object

Responsible for AE reporting to CA


Sponsor must declare reportable events to

Competent Authority
Relevant EC(s)

Reportable AEs

SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)

SUSAR being life-thereatening or leading to death must be reported

Within a max of 7d upon first knowledge (+ 8d for additional information)

All other SUSARs

Within a max of 15d upon first knowledge

Provision of Annual safety report mandatory


Annual safety report shall be provided by sponsor to

National CA
Relevant EC(s)

Guidance on AE reporting procedure available


Guidance on AE reporting procedure

Details on submission procedures are given in Circular n° 593 and Circular n° 586, provided on the FAMHP website in section: Human medicines > Medicines > Medicines > Research & Development > Clinical trials

Applicable national legal framework/ Reference

Chapter XV + XVI, Art 27 +28 Law 7 May 2004

Additional Information

The Belgian Centre for Pharmacovigilance for medicines for Human use (BCPH), that is part of the FAMHP, is responsible for the coordination of the different tasks related to pharmacovigilance.

Investigator shall report SAE to


Reporting timeline