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

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

2. AS assessment scheme in France • Outcomes for AIR2 substances • Outcomes for AIR3 substances

3. 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

4. AIR 2

5. 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

6. 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

7. 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

8. 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.

9. 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

10. AIR 3

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

12. 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Not fully own data package (physical availability / decision making before getting the letter of access) • Old studies not peer-reviewed

13. 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

14. 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

15. 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?

16. Conclusions

17. 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

18. Thank you! www.agriculture.gouv.fr www.anses.fr