1. Training Session Product File Notes and Registration Reports, 23 October 2006 1 Welcome ! Federal Public Service of Public Health, Food Chain Safety and Environment Belgium

2. Training Session Product File Notes and Registration Reports, 23 October 2006 2 Product File Note and Registration Report Training Session Morning session : Product File Note Afternoon session : Registration Report

3. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 3 Training Session Product File Notes and Registration Reports Looking for a Fast Track Authorization ? We offer following possibilities : - Mutual Recognition - Registration Report - Product File Note

4. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 4 Training Session Product File Notes and Registration Reports TO HELP US !

5. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 5 Training Session Product File Notes and Registration Reports Final goal = shorter pipeline - For your product - For (your) following products as well Quality = speed

6. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 6 Training Session Product File Notes and Registration Reports Mutual Recognition Obligatory only if : - Same or comparable product - All a.s. included in annex I - Authorization granted following evaluation of an annex III dossier according to Uniform Principles - For same or comparable agro-climatic conditions Works rather good from UK and Netherlands

7. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 7 Training Session Product File Notes and Registration Reports Registration Report - Presentation and evaluation of the annex III dossier - Required in order to allow for Mutual Recognition - Necessary if all a.s. included in annex I or if DAR available - Can be drafted by the applicant according to the model of the European Guidance Document Sanco/10798/2003 (adapted for Belgium)

8. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 8 Training Session Product File Notes and Registration Reports Product File Note - Presentation of the application to the Autorisation Committee - Possible when no Registration Report is necessary - Can be drafted by the applicant

9. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 9 Training Session Product File Notes and Registration Reports Choice between RR and PFN if more a.s. See « Possibilities of fast track authorisation procedures » : - All a.s. in annex I : RR - At least one old a.s. without DAR : PFN (except if also a.s. new for Belgium) - At least one old a.s. non included but with DAR : RR (except in combination with other old a.s. : PFN) - At least one new a.s., in annex I or DAR : RR (except if also old a.s. without DAR) Remark : RR should be drafted or updated after inclusion of all a.s. (Re-Registration)

10. Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 2006 10 Training Session Product File Notes and Registration Reports Feelin’ wanted yet ?