French feed back about AIR 2 & AIR3 Léa Riffaut, Jérémy Pinte

AS assessment scheme in France Outcomes for AIR2 substances Outcomes for AIR3 substances

FR scheme for AS Splitting between scientific evaluation and decision making: Anses vs. Ministry of Agriculture A single desk: Anses (DPR) Anses: scientific evaluation and administrative checks (CoC) → MAAF MAAF: regulatory issues (data protection), risk mitigation & decision making → COM, EFSA, MSs, Notifier

AIR 2

FR Outcomes of AIR2 AIR2: 31 AS, 31 RMS, 31 co-RMS FR AIR2: 6 AS, 5 as RMS, 1 as co-RMS As RMS: different worksharing options tested – RMS drafting, co-RMS review (3) – RMS and co-RMS co-drafting (2) As co-RMS: review of RMS' assessment

FR Outcomes of AIR2 Assessment at FR level: approx. on time Now at EU assessment level – 3 after 'additional information' step – 1 before 'additional information' step – 1 about to be fully evaluated by EFSA

FR Outcomes for AIR2 RMS and co-RMS usually agreed. – Few disagreements listed in Vol1/Lev3 FR conclusions on the assessment – Proposal of non-approval due to higher protection goals – Proposal of approval Change of end-point(s) Change of EU-harmonised classification

FR Outcomes of AIR2 As RMS with a co-RMS co-drafting the RAR – Interesting and valuable exchanges – (Little) Extra work due to Co-ordination of evaluator's workload and cross commenting of conclusions of assessment Interdependance of sections: need of detailed scheduling of the evaluation in order not to await some input values from the other MS/section.

FR Outcomes for AIR2 Communication at every step – Between RMS and co-RMS – Within RMS – Between RMS, co-RMS and EFSA (in case of worksharing and co-drafting) Hard point: referring to the existing DAR vs. drafting a stand-alone RAR – Renewal is not assessment of a NAS

AIR 3

FR Outcomes for AIR3 Pre-notification steps Some pre-submission meetings … Some delays for decisions for pre- notifications

FR Outcomes for AIR3 Prenotifications – Some negative decisions Uncomplete prenotifications On-going discussions between parties – Challenging pending questions Notification of studies: – Partial list (possible amendment?) – Not fully own data package (physical availability / decision making before getting the letter of access) – Old studies not peer-reviewed

FR Outcomes for AIR3 Some meetings before supplementary dossier submission – Interesting and valuable steps With co-RMS and industry Workscheduling (pending studies, worksharing) – EU harmonised classification: No existing classification Existing classification challenged

FR Outcomes for AIR3 Communication – For every step, as early as possible With(in) industry and with (co-)RMS Quality of (finalised) prenotifications Homogeneous treatment of notifiers

FR worries for AIR3 Access to data for very old dossiers New procedure – New template for the RAR (stand-alone RAR & retyping paper copies of ancient DARs) – Changing deadlines for end of approval Change of MS as RMS between approval and renewal Workload: no spare evaluation time, difficulties for 2015 → delayed RARs? Postponed end of approval?

Conclusions

Full implementation of R(EC)1107/2009 Heavy workload – Starting with dossiers of ASs – Which will feed the art. 43 PPP re- authorisation: RMS for AS → zRMS for PPPs – Impact on periods of approval for AIR3 ASs. Need of planification, communication Experiencing a new procedure with AIR3

Thank you!