making the zonal system work -feedback from southern zone- miriam cavaco head of authorization of...
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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
1Regulatory Conference-ECPA/ECCA, Brussels, 12th March 2015Regulatory Conference-ECPA/ECCA, Brussels, 12th March 2015
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.
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OVERVIEW
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 emails exchanges; Teleconferences: every 2 months; Face to face meetings: 1 per year (July 2014 – Paris)
Zonal Steering Committee
WORKING PROCEDURES IN SOUTHERN ZONE
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.
Steering Committee Tasks
WORKING PROCEDURES IN SOUTHERN ZONE
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.
Chair tasks
WORKING PROCEDURES IN SOUTHERN ZONE
• 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.
SMS - SC of July 2014 in Paris
WORKING PROCEDURES IN SOUTHERN ZONE
IMPORTANT
INFORMATION
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.
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OVERVIEW
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Pre-notifications; Pre-submission meetings; Completeness check; Quality of the dRR; Efficacy data.
Zonal submissions received and areas to improve
FEEDBACK FROM ZONAL SUBMISSIONS
NEW PPP
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.
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Quality of the dRR
ZONAL SUBMISSIONS RECEIVED AND AREAS TO IMPROVE
not supposed to happennot supposed to happen
• 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 dRRlimited timeframes do not allow to revisit evaluations already carried out
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Quality of the dRR
ZONAL SUBMISSIONS RECEIVED AND AREAS TO IMPROVE
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.
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OVERVIEW
• 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
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HARMONIZATION WITHIN THE ZONEHARMONIZATION WITHIN THE ZONE
Evaluation based on harmonized basis
National data requirements
The applicants are advised to follow the requirements described in Southern Zone Guidance document (version December 2013):
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HARMONIZATION WITHIN THE ZONEHARMONIZATION WITHIN THE ZONE
National data requirements
The procedure for appointing zRMS is described; Contact Points in Each MS; Definition of the national data requirements.
https://circabc.europa.eu/w/browse/71968c1f-bf75-4f4a-867b-47a9f7453319
“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 917414/EEC”
Evaluation based on harmonized basis National data requirements
CoordinationCommunicationPlanningMonitoring
• Between MSs (ZSC and iZSC)
• Between MSs and applicants
• Between MSs (ZSC and iZSC)
• Between MSs and applicants
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One zone one approach
HARMONISATION WITHIN THE ZONEHARMONISATION WITHIN THE ZONE
PT organized a Director’s Consultation Group Meeting on 17th November 2014 in Lisbon.
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.
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Director’s Consultation Group (DCG) of SMS
HARMONISATION WITHIN THE ZONEHARMONISATION WITHIN THE ZONE
FR proposed to host a South EG on efficacy in 2015 (?)FR proposed to host a South EG on efficacy in 2015 (?)
HARMONISATION OF ZONAL ASSESSMENTHARMONISATION OF ZONAL ASSESSMENT
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RR (Part A +B +C)
Concerned Member States need:
Registration Report (A+B+C);
Copy of the authorisation.
Re-registration (Voluntary Worksharing)
New apllications
Eficaccy issuesArticle 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).”
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).”
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Renewal of authorizations (Article 43)
PLANNING THE WORKLOAD
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.
ZRM is a notified concerned MS:
oEven some uses are not registered in ZRMS
Between concerned MS:
o Choose the RMS or the co-RMS
Capacities of MS
PLANNING THE WORKLOAD
Allocation of ZRMS (AIR2)
PLANNING THE WORKLOAD
Allocation of ZRMS (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.
PLANNING THE WORKLOAD
Procedure of evaluation (AIR2)
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.
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OVERVIEW
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To avoid duplication of the work :
• Facilitate work-sharing especially between zones
Interzonal worksharing Inter-Zonal Core dossier:
• Identity and analytical methods;•Toxicology;
HARMONISATION BETWEEN THE ZONESHARMONISATION BETWEEN THE ZONES
“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)
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 .
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Zonal evaluation
CONCLUDING REMARKS
