Pharmacovigilance – ICSR submissions guidelines – updated
The EMEA has published new EudraVigilance Business Rules for exchanging Safety/Acknowledgement Messages and Individual Cases Safety Reports (ICSRs) in the EEA in line with Regulation (EC) No 726/2004, Directive 2001/83/EC as amended, Directive 2001/20/EC, Volume 9A and Volume 10 of the Rules Governing Medicinal Products in the European Union.