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.

These Business Rules are presented in the Note for Guidance EudraVigilance Human – Processing of Safety Messages and Individual Case Safety Reports (ICSRs) (Doc. Ref. EMEA/H/20665/04/Final – Revision 1).

In order to avoid disruptions in the data exchange process of safety messages and ICSRs, a detailed implementation plan has been prepared to ensure a coordinated implementation approach of the revised EudraVigilance business rules within the Community. The implementation plan is addressed in
the document Ref. EMEA/665231/2008: Implementation Plan for The Note for Guidance EudraVigilance Human – Processing of Safety Messages and Individual Case Safety Reports (ICSRs) (Doc. Ref. EMEA/H/20665/04/Final, Revision 1).

Stakeholders will have until 01 June 2010 to implement these new business rules for preparing and processing ICSRs in the EEA.

The new business rules and the implementation plan are available on the EMEA website:
http://www.emea.europa.eu/htms/human/
phv/phvwp.htm

and
the EudraVigilance website:
http://eudravigilance.emea.europa.eu/human /index.asp

If you have any questions concerning these two documents, please do not hesitate to contact the EudraVigilance helpdesk (Tel. +44 (0)20 7523 7523)