> Report an adverse reaction
> Direct healthcare professionals communications
> Medicines under additional monitoring
> Questions and answers on medicinal product safety
> Information for marketing authorisation holders
> Pharmacovigilance specific legislation

Information for marketing authorisation holders and sponsors of clinical trial

Electronic Reporting of Spontaneous Individual Case Safety Reports (ICSRs) by marketing authorization holders
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Electronic Reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) by sponsors of clinical trials
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Questions and answers on the PSUR Repository and Periodic Safety Update Report submission.
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List of Romanian medical publications recommended for monitoring by Marketing Authorization Holders.
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List of medical literature monitored by the European Medicines Agency (EMA).
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List of active substances monitored in the medical literature by the European Medicines Agency (EMA).
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