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Product File Note Model 3. Biology 3.1
Efficacy and selectivity
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The product file note should be in line with the
proposed label ! All uses and conditions of use
should be at least presented in Dutch and French
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Example Winter wheat
If special crop, eg chou frisé boerekool
(krulkool) Curly kale Use latin name
Brassica oleracea var sabellica Crop names
are described on Fytoweb and Bayer Code
BRSOC Managed by EPPO
F. Cors B. Weickmans October 23,
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And Max product amount
Not relevant if application at a well defined
crop stage
If risk identified
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Should be identified by Latin name and Bayer
Code
And consult
Only if some efficacy but not enough to grant
full approval
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by ha Leaf-wall area for vertical crop
EPPO PP 1/239
Herbicides Splitting of the full dose !
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• Mutual recognition
• The applicant should verify that the GAP are
• comparable in the 2 countries for
• crop husbandry
• enemy
• material
• .
• .
• .
• and justify all difference
• The Registration Report of the reference MS
  should be
• added as well as updated Doc C and D

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Biological dossier
All original full trial reports should be added
Trials should be clearly identified and
referenced
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2006 9
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Biological dossier
Means should be compared for the same number of
trials
Different assessments should be compared in
different tables e.g. for efficacy duration
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Biological dossier
Data on CD in .doc (Word) or .pdf (Acrobat)
files
Organization of files the same as the paper
version Access to trial reports should be quick
and easy
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