SAE (Serious Adverse Event)
SUSAR (Suspected Unexpected Serious Adverse Reaction)
Within a max of 7d upon first knowledge (+ 8d for additional information)
Within a max of 15d upon first knowledge
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
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.