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 …
List of Romanian medical publications recommended for monitoring by Marketing Authorization Holders
download document …
List of medical literature monitored by the European Medicines Agency (EMA)
download document …
List of active substances monitored in the medical literature by the European Medicines Agency (EMA)
download document …