National Competent Authorities Implementation of Electronic Initiatives - Opportunities and Challenges Initial Assessment of Impact of National Competent Authorities Requirements

1. Working in an e-only regulatory environment: An applicant’s experience in Belgium Marie-Laure Freshard Alain Seront DIA European Regulatory Affairs Forum, Munich November 2008

13. Initial response of headquarters Modules 2 to 5 Modules1 to 5 BMS headquarters Prepares common Modules 2 to 5 BMS local office Add local Module 1 Send dossier to local NCA National Competent Authority 1 2 3 + Mod. 1 PAPER Mutual Recognition Procedure Modules1 to 5 BMS local office Prepare the complete dossier Send dossier to local NCA National Competent Authority 1 2 PAPER National Procedure

14. Modules 1 to 5 1 to 5 1 to 5 1 to 5 1 to 5 1 to 5 1 to 5 1 to 5 + Mod. 1 + Mod. 1 + Mod. 1 + Mod. 1 + Mod. 1 + Mod. 1 + Mod. 1 + Mod. 1 Paper - MRP 2 to 5 Modules 2 to 5 2 to 5 2 to 5 2 to 5 2 to 5 2 to 5 2 to 5

16. + Mod. 1 PAPER NEES National Competent Authority BMS local office Send local Module 1 to HQ 1 Modules1 to 5 BMS local office Add local Module 1 2 Modules 1 to 5 National Competent Authority Modules 2 to 5 Local Module 1 Modules 1 to 5 1 BMS headquarters Prepares common Modules 2 to 5 2 BMS headquarters Prepares common Modules 2 to 5 and local Module 1 3 Send dossier to local NCA 3 Send dossier to local NCA

17. 1 to 5 1 to 5 1 to 5 1 to 5 1 to 5 1 to 5 1 to 5 1 to 5 1 to 5 1 1 to 5 1 2 to 5 1 to 5 1 + Mod. 1 + Mod. 1 + Mod. 1 + Mod. 1 + Mod. 1 Paper & electronic MRP and National 2 to 5 2 to 5 2 to 5 2 to 5