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Tag: pharmacovigilance

4. PHARMACOVIGILANCE, INCL. ADVERSE REACTIONS REPORTING

QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC 4.1. [NEW] Is there any impact on reporting into EudraVigilance of Individual Case Safety Reports (ICSRs)? According to Article 107 of Directive 2001/83/EC, MAHs shall submit electronically to the Eudravigilance database all serious suspected adverse reactions that occur in […]