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

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

Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 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

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

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

Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 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

Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 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)

Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 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

Federal Public Service ‘Public Health, Food Chain Safety and Environment’ 23 October 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)

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