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Update on the review of active substances

Regulatory Conference - ECCA & ECPA 12-13 March 2014. Update on the review of active substances. Jeroen Meeussen European Commission DG SANCO. The AIR programmes. AIR-1 – 7 substances – 14 MS AIR-2 – 31 substances – 21 MS AIR-3 – 150 substances – 28 MS. Current situation (AIR-1).

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Update on the review of active substances

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  1. RegulatoryConference - ECCA & ECPA12-13 March 2014 Update on the review of active substances Jeroen Meeussen European Commission DG SANCO

  2. The AIR programmes • AIR-1 – 7 substances – 14 MS • AIR-2 – 31 substances – 21 MS • AIR-3 – 150 substances – 28 MS

  3. Current situation (AIR-1) • All decisions on Annex I Renewal (AIR-1). substances have been taken - 7 substances • Regulation is applicable from: 1 January 2012. • Re-authorisation of products: 31 December 2015. • Expiry of approval: 31 December 2021.

  4. Current situation (AIR-2) • Regulation (AIR-2) has been published in December 2010: (EU) No 1141/2010. • Guidance Document has been noted (SANCO/10387/2010 - rev. 8). • 31 substances: 29 dossiers have been received; peer-review is ongoing. • Expiry of approval: 31 December 2015.

  5. Current situation (AIR-3) • Regulation ("AIR-3") with the general procedure: Reg. (EU) No 844/2012. • List of RMS & Co-RMS for substances expiring by 31/12/2018: Reg. (EU) No 686/2012. • Guidance Document has been noted (SANCO/2012/11251 - rev. 1.2).

  6. Time 0 1 month 11 months 1.5 months 2 months 5 months 3 months 6 months 29.5 months Renewal Timelines (Reg. 844/2012) Activity - Dossier submission: - Admissibility check: - Renewal Assessment Report (RAR): - RAR circulated to MS and applicant: - Public Commenting(incl. MS & applicant): - EFSA peer-review: - Stop the clock: - COM decision: Max Total -6-

  7. Underlying principles

  8. 1. A workable programme

  9. 2. Stepwise implementation • The extension of the approvals will be done in batches. • Condition: application submitted within the deadline. • If no dossier submitted  back to old expiry date.

  10. 3. Data requirements • The new data requirements should apply to all substances. • Starting date for submission of dossiers: after1 January 2014 (related to the new data requirements).

  11. AIR-3 substances 1 Reg. 823/2012 Reg. 1197/2012 2 Extension only if application submitted within deadlines 3 4

  12. GROUP 1 : 40 substances expiringbefore 14 June 2014 Reg. 823/2012 extending the expiry dates Dossier submission Application ExtendedE-date – 3 y ExtendedE-date – 2.5 y Batch 1: 31/1/2014 Extended expiry date 31/7/2016 31/10/2016 31/01/2017

  13. Group 1 Reg. 186/2014 Reg. voted

  14. GROUP 2: 27 substances expiring 7/2014 – 11/2015 Reg. 1197/2012 extending the expiry dates* Application (using format Reg. 844/2012) Dossier submission Application OriginalE-date – 3 y Extended E-date – 3 y Extended E-date – 2.5 y Extended expiry date30/4/2017 31/7/2017 Received for 23 substances Applicable to 23 substances * Only if application requesting renewal was received (23 substances)

  15. GROUP 3: 55 substances expiring2/2016 – 11/2017 Extend expiry date only if application received Application (using format Reg. 844/2012) Current E-date – 3 y Dossier submission Extended expiry date31/10/2017 31/1/2018 30/4/2018 Extended E-date – 2.5 y Adopt regulation as regards extended expiry dates

  16. GROUP 3: 55 substances expiring 2/2016 – 11/2017 Several Regulations extending the approval Regulation (EU) No 533/2013; Regulation (EU) No 762/2013; Regulation (EU) No 1136/2013; Regulation (EU) No 85/2014; …and more to follow. • Condition: the application has been submitted • Extension to be adopted beforethe dossier submission • Message for industry: submit the application as soon as possible

  17. GROUP 4: substances expiring as from 31/7/2018 No extension Dossier submission Application E-date – 3y E-date – 2.5 y Expiry date

  18. Overview Documents (1)

  19. Overview Documents (2)

  20. New Data Requirements • Apply from 1 January 2014; • Commission Regulations (EU) No 283/2013 and No 284/2013 of 1 March 2013 (published OJ on 03/04/2013); • Commission Communications 2013/C 95/01 and 2013/C 95/02.

  21. New Data Requirements • Active Substance: - for all applications submitted under Regulation 844/2012; • Products: - Not to AIR-1 and AIR-2 as long as applications for re-authorisation are submitted before 31 December 2015;- Applicable to all re-authorisations AIR-3.

  22. Conclusions • Legal framework for AIR-3 has been adopted. • Extensions only possible if an application has been submitted. • Submit applications as soon as possible. • Challenge to cope with the deadlines. • Urgent need to address a number of issues for renewal of authorisations. • What about submissions after AIR-3?

  23. Workload

  24. Anyquestions? Thankyou for your attention

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