Transcript www.ecpa.eu

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
1
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.
2
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 emails exchanges;
Teleconferences: every 2 months;
Face to face meetings: 1 per year (July 2014 – Paris)
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.
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.
WORKING PROCEDURES IN SOUTHERN ZONE
SMS - SC of July 2014 in Paris
• 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.
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.
7
FEEDBACK FROM ZONAL SUBMISSIONS
Zonal submissions received and areas to improve





Pre-notifications;
Pre-submission meetings;
Completeness check;
Quality of the dRR;
Efficacy data.
NEW PPP
8
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

not supposed to
happen
Acess to a complete “Annex II” dossier ( a.s. - Reg. 283/2013) must
be demonstrated.
9
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
10
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.
11
HARMONIZATION WITHIN THE ZONE
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:
National data
requirements
Depends on national rules in MS;
 Better harmonization of risk mitigation measures

to gain efficiency in worksharing
12
HARMONIZATION WITHIN THE ZONE
Evaluation
National data
basedrequirements
on harmonized basis

National data
requirements
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.
“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”
https://circabc.europa.eu/w/browse/71968c1f-bf75-4f4a-867b-47a9f7453319
13
HARMONISATION WITHIN THE ZONE
One zone
one approach
Coordination
Communication
Planning
• Between MSs (ZSC and iZSC)
• Between MSs and applicants
Monitoring
PT organized a Director’s Consultation Group
Meeting on 17th November 2014 in Lisbon.
14
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.
15
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
Eficaccy issues
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
application
to in Article
36(2)
FR proposed
to the
host
a South as
EGreferred
on efficacy
in 2015
(?)and (3).”
16
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.
17
PLANNING THE WORKLOAD
Allocation of ZRMS (AIR2)

ZRM is a notified concerned MS:
o Even some uses are not registered

Between concerned MS:
o Choose

the RMS or the co-RMS
Capacities of MS
in ZRMS
PLANNING THE WORKLOAD
Allocation of ZRMS (AIR2)
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.
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.
21
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)
22
CONCLUDING REMARKS
Zonal evaluation
 Offers the opportunity to:
 Requires from all partners:
Discussion of commom problems;
Increase of cooperation between
Reduce workload by worksharing;
Trust in the work done by others;
Harmonise requirements.
Willingness to harmonize
MS and MS/Applicants;
requirements .
23
We need to make it work
Everyone benefits
[email protected]
24