1. Making the zonal system work -Feedback from Southern Zone-
Miriam Cavaco
Head of Authorization of Plant Protection Products Division
General Directorate of Food and Veterinary
Regulatory Conference-ECPA/ECCA, Brussels, 12th March 2015

2. OVERVIEW
Working procedures in Southern Zone;
Feedback from zonal submissions:
Zonal submissions and areas to improve;
Harmonisation within the zone;
Harmonisation between the zones;
Concluding remarks.

3. WORKING PROCEDURES IN SOUTHERN ZONE
Zonal Steering Committee
1 representative from each MS of the zone;
Chair: one MS for 1 year on a rotational basis plus one co –chair;
Since October 2014 is chaired by Spain and Portugal (co-chair);
Contacts: Regular s exchanges;
Teleconferences: every 2 months;
Face to face meetings: 1 per year (July 2014 – Paris)

4. WORKING PROCEDURES IN SOUTHERN ZONE
Steering Committee Tasks
Stage of progress with regard to the assessment of plant protection products (New PPP, re-registration);
Distribution of work among MS;
Update the data base of applications and authorizations;
Discution of issues raised by MS or/and by applicants;
Discution of topics from iZSC and report issues from SC.

5. WORKING PROCEDURES IN SOUTHERN ZONE
Chair tasks
Organisation of teleconferences and the face to face meeting;
Prepare the agenda;
Minutes of the teleconferences/ Annual Meeting;
Attend the iZSC;
Manage the updating of the Files with the zonal applications;
Collect remarks on relevant GD.

6. WORKING PROCEDURES IN SOUTHERN ZONE
SMS - SC of July 2014 in Paris
IMPORTANT INFORMATION
Worload for the chair is not negligible;
All MS are not equally involved in the activities of ZSC /SMS;
New sharing of the tasks in order to reduce the workload of the chair
Chair: coordinate the SMS-SC and contact with iZSC;
Other MS: drafting the minutes, update EXCELL worksharing tables.

7. OVERVIEW
Working procedures in Southern Zone;
Feedback from zonal submissions:
Zonal submissions and areas to improve;
Harmonisation within the zone;
Harmonisation between the zones;
Concluding remarks.

8. FEEDBACK FROM ZONAL SUBMISSIONS
Zonal submissions received and areas to improve
NEW PPP
Pre-notifications;
Pre-submission meetings;
Completeness check;
Quality of the dRR;
Efficacy data.

9. ZONAL SUBMISSIONS RECEIVED AND AREAS TO IMPROVE
Quality of the dRR
Influences the time keeping process and resource efficiency of CAs;
RR is supposed to be a stand-alone document:
dRR making reference to other RR
Acess to a complete “Annex II” dossier ( a.s. - Reg. 283/2013) must be demonstrated.
not supposed to happen

10. ZONAL SUBMISSIONS RECEIVED AND AREAS TO IMPROVE
Quality of the dRR
The GAP does not represent the uses in the zone;
is not the same in all parts of the dRR;
in dRR conflits with the GAP in national application.
Changes of the GAP by the applicant during the evaluation of the dRR
limited timeframes do not allow to revisit evaluations already carried out
A RR is supposed to be a stand-alone document that supports the authorizations;

11. OVERVIEW
Working procedures in Southern Zone;
Feedback from zonal submissions:
Zonal submissions and areas to improve;
Harmonisation within the zone;
Harmonisation between the zones;
Concluding remarks.

12. HARMONIZATION WITHIN THE ZONE National data requirements
Evaluation based on harmonized basis
South MS rely mostly on EU data requirements;
Are rather limited to specifics crops;
Risk mitigation measures are not fully harmonized:
Depends on national rules in MS;
Better harmonization of risk mitigation measures
to gain efficiency in worksharing
National data requirements
All the information necessary for applications in the SZ (i.e. contact points, national requirements and national risk mitigation measures) is available in the GD Working document on the voluntary work-sharing of the southern zone member states in the re- registration of PPP following inclusion of an a.i. in annex I of council directive 91/414/EEC – revised version December 2013

13. National data requirements
HARMONIZATION WITHIN THE ZONE
National data requirements
National data requirements
Evaluation based on harmonized basis
The applicants are advised to follow the requirements described in Southern Zone Guidance document (version December 2013):
The procedure for appointing zRMS is described;
Contact Points in Each MS;
Definition of the national data requirements.
All the information necessary for applications in the SZ (i.e. contact points, national requirements and national risk mitigation measures) is available in the GD Working document on the voluntary work-sharing of the southern zone member states in the re- registration of PPP following inclusion of an a.i. in annex I of council directive 91/414/EEC – revised version December 2013
“Working document on the voluntary work-sharing of the Southern Zone Member states in the re-registration of PPP following the inclusion of an a.i. in Annex I of Council Directive /EEC”

14. HARMONISATION WITHIN THE ZONE
One zone one approach
Coordination
Communication
Planning
Monitoring
Between MSs (ZSC and iZSC)
Between MSs and applicants
New rules impose more
PT organized a Director’s Consultation Group Meeting on 17th November in Lisbon.

15. HARMONISATION WITHIN THE ZONE
Director’s Consultation Group (DCG) of SMS
To improve the sharing of the regulatory process for greater efficiency and effectiveness;
To increase the mutual understanding of current policies;
To harmonise practices between Competent Authorities of SMS.

16. HARMONISATION OF ZONAL ASSESSMENT
RR (Part A +B +C)
Concerned Member States need:
Registration Report (A+B+C);
Copy of the authorisation.
Re-registration (Voluntary Worksharing)
New apllications
Article 37, paragraph 4:
“The other Member States concerned shall at the latest within 120 days of the receipt of the assessment report and the copy of the authorisation of the Member State examining the application decide on the application as referred to in Article 36(2) and (3).”
Eficaccy issues
FR proposed to host a South EG on efficacy in 2015 (?)

17. Renewal of authorizations (Article 43)
PLANNING THE WORKLOAD
Renewal of authorizations (Article 43)
In order to plan the workload (As in Central Zone)
Have sent letters (July) to all applicants asking :
to notify the dossiers that will be submitted -EXCELL file.
Greece gathered all the information submitted.
Last teleconference made a distribution of all PPP.
Prospective workload from forthcoming applications
How to identify the number of dossiers that will be submitted ?

18. ZRM is a notified concerned MS:
PLANNING THE WORKLOAD
Allocation of ZRMS (AIR2)
ZRM is a notified concerned MS:
Even some uses are not registered in ZRMS
Between concerned MS:
Choose the RMS or the co-RMS
Capacities of MS

19. PLANNING THE WORKLOAD
Allocation of ZRMS (AIR2)

20. PLANNING THE WORKLOAD
Procedure of evaluation (AIR2)
The ZRMS will evaluate all the GAP in the southern zone
Decision:
Each Ms We will only renew the uses already authorized in that MS.

21. OVERVIEW
Working procedures in Southern Zone;
Feedback from zonal submissions:
Zonal submissions and areas to improve;
Harmonisation within the zone;
Harmonisation between the zones;
Concluding remarks.

22. HARMONISATION BETWEEN THE ZONES
To avoid duplication of the work :
Facilitate work-sharing especially between zones
Interzonal worksharing Inter-Zonal Core dossier:
Identity and analytical methods;
Toxicology;
“Where the application is made in more than 1 zone, MS …. shall agree on the evaluating data which are not related to the environmental and agricultural conditions.” (Article 35)

23. CONCLUDING REMARKS Zonal evaluation Offers the opportunity to:
Discussion of commom problems;
Reduce workload by worksharing;
Harmonise requirements.
Requires from all partners:
Increase of cooperation between MS and MS/Applicants;
Trust in the work done by others;
Willingness to harmonize requirements .

24. We need to make it work
Everyone benefits