1. Experiences with the AIR 2 evaluation and decision-making Herbert Köpp BVL Germany

2. 10 March 2015Seite 2 Experiences with AIR 2 / Herbert Köpp Legal basis Regulation (EU) No 1141/2010 [EIF 28 Dec. 2010 ] – still under Council Directive 91/414/EEC Guidance Document SANCO/10387/2010-rev. 8 ‘old’ data requirements Decisions under Regulation (EC) No 1107/2009

3. 10 March 2015Seite 3 Experiences with AIR 2 / Herbert Köpp Dossiers 35 substances called up applications by 28 March 2011 for 31 substances some third-party submissions and 52 dossiers in 3 batches in 2012 for 29 substances

4. 10 March 2015Seite 4 Experiences with AIR 2 / Herbert Köpp

5. 10 March 2015Seite 5 Experiences with AIR 2 / Herbert Köpp Dossiers – remarks (1) One dossier per substance makes life easier for the RMS Task Forces were encouraged and in principle welcomed … but sometimes, a TF can have rather complex internal ‘affairs’ which make life difficult again for the RMS  consider to compile RMS’ experience with TF and develop some standard rules

6. 10 March 2015Seite 6 Experiences with AIR 2 / Herbert Köpp Dossiers – remarks (2) Mix of ‘old’ and new/supplemental dossier made assessing completeness and tracing old studies difficult.  requirement of a complete ref. list with old / new differentiation in AIR 3 [reg. 844/2012 Art. 7 (1) l] Publication of summary dossier: sanitisation process required some learning by all parties  was consolidated for AIR 3

7. 10 March 2015Seite 7 Experiences with AIR 2 / Herbert Köpp Evaluation 29 substances 21 MS involved:  14 as RMS  19 as co-RMS

8. 10 March 2015Seite 8 Experiences with AIR 2 / Herbert Köpp Timelines - evaluation & decision PhaseTime Dossier submission0 Completeness1 month Renewal Assessment Report11 months Commenting2 months EFSA peer review6 months Stop the clock3 months Decision6 months Total29 months

9. 10 March 2015Seite 9 Experiences with AIR 2 / Herbert Köpp RAR: 1 + 11 months

10. 10 March 2015Seite 10 Experiences with AIR 2 / Herbert Köpp Peer review - status 31 August 2012 [deadline for last dossiers] plus 29 months max. evaluation => all decisions by Feb. 2015 Commenting on the RAR: completed for all substances Additional information requested for all substances EFSA Conclusions: 23 [6 remaining] SCoPAFF decisions: 1

11. 10 March 2015Seite 11 Experiences with AIR 2 / Herbert Köpp Evaluation – remarks RAR preparation is more or less on time in most cases [2/3] but 8 of 29 exceed 18 months. Additional information is often a rather large data package; the time window for the RMS and co-RMS is often too short. Additional information: commenting period on the revised RAR really too short

12. 10 March 2015Seite 12 Experiences with AIR 2 / Herbert Köpp Evaluation – remarks (2) Renewal is only about new data, so it must be quicker !  Not realistic. New guidance, new science, lack of detail in old evaluations etc. require ‘re-opening’ of (many) old assessments.

13. 10 March 2015Seite 13 Experiences with AIR 2 / Herbert Köpp Evaluation – remarks (3) New RAR Volume 1: This posed some challenges, esp. in Level 3 [table with criteria for decision-making as in 1197/2009]. Also, new Vol.1 did not fit very well with old Vol. 3 [interim]. Review of published literature: not yet obligatory but done in several cases  experience used for new guidance on dossier and RAR

14. 10 March 2015Seite 14 Experiences with AIR 2 / Herbert Köpp Thank you for your attention! Questions? Seite 14 Contact: herbert.koepp@bvl.bund.de