News

Electronic reporting of SUSARs from other EU countries now possible

The Danish Medicines Agency can now receive electronic reports of suspected unexpected serious adverse reactions, also known as SUSARs, from trials in other EU countries. SUSARs that occur in other EU/EEA countries must be reported to the Danish Medicines Agency if the trials have the same protocol (EudraCT number) as in Denmark. The new opportunity of electronic submission applies to precisely these SUSARs.