15 (for monocentric Phase I trials)
(up to 90 days if the Belgian Biosafety Advisory Council has to be asked for advice)
No time limit
The ethics committee has to give a written reply and submits a copy to the CA.
ad multi-centre trials: Lead -EC delivers opinion within 20 days to local ECs of participating sites, local ECs have 5 days to respond to Lead -EC, Lead-EC has 3 days to issue final single opinion to investigator.