uk national authorisations fay beacon pesticides branch
TRANSCRIPT
Topics
• Authorisation types and numbers
• Legislation
• Zonal process
• Applications to CRD
• Further information
Authorisation types
• Authorisations for products used in agriculture, horticulture, forestry, home garden
• Parallel permits (free trade within EU)
• Experimental permits (for R&D)
• Extensions of use (minor use – no efficacy)
• Emergency authorisations
• Adjuvants
August 2010
0
100
200
300
400
500
600
700
800
900
1000
Herbicides Insecticides Fungicides Others
Professional
Parallel Imports
Amateur
UK authorised products
3385 products (2735 Professional and 650 Amateur) Based on 270 active substances
Legislation
Applies directly in all MS from 14 June 2011
Applications received before 14 June 2011 still 91/414 (or national rules)
1107/2009 sets out procedures for most authorisation types. Adjuvants assessed under national rules as detailed rules not yet available.
Regulation 1107/2009
• Sets out assessment procedures and timelines
• Applications processed zonally
- 3 zones (North, Central, South)
- 1 zone for indoor use & seed treatments
• Gives rules for data protection
• Data requirements/ assessment standards currently same as 91/414
The Zonal Process
• Assessment by 1 MS (zonal RMS) comments by others (concerned MSs). Only national issues assessed by concerned MS
• MS co-operation essential
Developed by MS & COM
Agrees process for implementation including zonal steering committees
The Zonal Process - procedures under development
• Main difference between assessment by ‘concerned MS’ and Mutual recognition is timing of submission.
• EU database for management of product applications under development
• Approach to risk assessment not harmonised - National assessment required
• Choice of zonal RMS is industry’s, but high MS workloads making it difficult to agree zonal RMS
Application types
• Re-registration
- workload peaks 2011- 2015
- zonal procedures but national timelines
• New products & uses
- zonal procedures and timelines
- includes minor uses and mutual recognition
• Amendments (e.g. name change) and withdrawals
• Parallel permits
• Experimental permits
• Adjuvants (national rules)
No MS comments
Total apps. 1500-2000 each year
Overview of zonal timelines
Submission deadline
Completion deadline
0 m 12 m
- 6 m
Applicant alerts zonal reps,
pre-submission meetings etc
ZRMS initialevaluation
8 m 6 weeks
Comments by other MS
2.5 m
ZRMS finalEvaluation and authorisation
Identification by ZRMS of further requirements
6 m+ 120 d
‘Following’ Zonal
(and MR) deadline
Clock stops for up to 6 months where further data requested (Timelines also suspended if an equivalence check is required)
(+6 m)
APPLICATION
APPROVALS ADMIN
FINANCEREGISTRY
APRROVALS ADMIN FINANCE
SIFT
RESPONSIBLE OFFICER
SPECIALISTS
RESPONSIBLE OFFICER
APPROVALS ADMIN
Request clarification
Recommendation
Govt. Depts.
SIFT
EVALUATION