Transcript Prezentace aplikace PowerPoint

www.ukzuz.cz
Central Institute for Supervising and Testing in Agriculture
ISO 9001: 2008
www.ukzuz.cz
Guidance Documents
ECCA + ECPA Regulatory Conference
2015
Brussels
Dr. Pavel Minar
Division of Plant Protection Products
Guidance Documents
Central Institute for Supervising and Testing in Agriculture
ISO 9001: 2008
www.ukzuz.cz
Content
• Initiation and implementation of
new texts
• Impact on the authorisation
process
• Conclusions + suggestions
Guidance Documents
Central Institute for Supervising and Testing in Agriculture
ISO 9001: 2008
www.ukzuz.cz
COM
- procedural documents
- DG SANCO web pages
EFSA
- risk-assessment procedures, expert
opinion on some scientific issues
- European Food Safety Authority web
pages
Guidance Documents
Central Institute for Supervising and Testing in Agriculture
ISO 9001: 2008
www.ukzuz.cz
COM GD Status
• Not legally binding
• Present consensus between MS’s
and COM as to the procedures and
interpretation of legal provisions
• Not high impact on application
costs
Guidance Documents
Central Institute for Supervising and Testing in Agriculture
ISO 9001: 2008
www.ukzuz.cz
• Some GD for a long time period as a
draft (Working Documents)
• Many versions
• Some drafts used before approval
• Approval – taking note at the Standing
Commitee
Guidance Documents
Guidance Documents
Guidance Documents
Summary table of GDs
Guidance Documents
Central Institute for Supervising and Testing in Agriculture
ISO 9001: 2008
www.ukzuz.cz
EFSA GD Initiation
• Commission - request to EFSA (Art 29
of 178/2002)
•
Initiating a mandate on EFSA own
initiative (Art 29 of 178/2002)
•
Pesticide Steering Committee –
based on priorities
Guidance Documents
Central Institute for Supervising and Testing in Agriculture
ISO 9001: 2008
www.ukzuz.cz
GD for the Risk - Asessment
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Identification of a need
Drafting a mandate
Collection of data
Opinion of the PPR Panel
Establishment of a Working Group
Preparation, adoption (or approval)
Consultations
Entry into force
Guidance Documents
Central Institute for Supervising and Testing in Agriculture
ISO 9001: 2008
www.ukzuz.cz
• Regulators and applicants shall respect
Guidance Documents
• Those GD to be used valid by the date
of submission
• Regulators and applicants should be
aware of valid version of GD’s
• Date of implementation should be clear
Guidance Documents
Guidance Documents
Central Institute for Supervising and Testing in Agriculture
ISO 9001: 2008
www.ukzuz.cz
GD for the Risk - Asessment
• COM decides on application time
schedule
• Complex and often large documents
(which increases)
• Training of specialists or workshops
Guidance Documents
Central Institute for Supervising and Testing in Agriculture
ISO 9001: 2008
www.ukzuz.cz
Critical points
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Mandate for EFSA
Working group
Capacity of experts to comment
Processing of comments and discussion
Impact analysis + model cases
Training
Guidance Documents
Central Institute for Supervising and Testing in Agriculture
ISO 9001: 2008
www.ukzuz.cz
Conclusions
• Information for risk managers on
changes and differencies in decisionmaking and risk-management
• Implementation timelines should
reflect the capacity of laboratories and
authorities
• Sufficient time for training of assessors
Guidance Documents
Central Institute for Supervising and Testing in Agriculture
ISO 9001: 2008
www.ukzuz.cz
Conclusions
• GD shall reflect the good agricultural
practice
• Feedback on the implementation of
guidance document and adjustments
• Testing phase should be a standard
step
• Implementation timelines?
Guidance Documents
Central Institute for Supervising and Testing in Agriculture
ISO 9001: 2008
www.ukzuz.cz
Conclusions
• Complexity should be related to the
time for analysis, studying,
commenting and implementation
• Model comparisons are missing
• Transparent discussion
Guidance Documents
Central Institute for Supervising and Testing in Agriculture
ISO 9001: 2008
www.ukzuz.cz
Conclusions
• Use of the same GD‘s during the
lifetime of the active substances (not
from the middle of it) but….
• …what about the mutual recognition
Guidance Documents
Ústřední kontrolní a zkušební ústav zemědělský
ISO 9001: 2008
www.ukzuz.cz
Thank you for your attention!
Pavel Minar
602234663
[email protected]
www.ukzuz.cz