Information regarding the nomination of a contact person for pharmacovigilance issues at national level
download document … ![]()
Electronic Reporting of Spontaneous Individual Case Safety Reports (ICSRs) by marketing authorization holders
download document … ![]()
Electronic Reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) by sponsors of clinical trials
download document … ![]()
Questions and answers on the PSUR Repository and Periodic Safety Update Report submission
download document … ![]()
Substances and medical literature covered by EMA’s service
download document … ![]()


