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Product File Note Model 3. Biology 3.1 Efficacy and selectivity

Product File Note Model 3. Biology 3.1 Efficacy and selectivity. F. Cors & B. Weickmans October 23, 2006 1. The product file note should be in line with the proposed label !

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Product File Note Model 3. Biology 3.1 Efficacy and selectivity

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  1. Product File Note Model 3. Biology 3.1 Efficacy and selectivity F. Cors & B. Weickmans October 23, 2006 1

  2. 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 F. Cors & B. Weickmans October 23, 2006 2

  3. 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, 2006 3

  4. And Max product amount Not relevant if application at a well defined crop stage If risk identified F. Cors & B. Weickmans October 23, 2006 4

  5. Should be identified by Latin name and Bayer Code And consult Only if some efficacy but not enough to grant full approval F. Cors & B. Weickmans October 23, 2006 5

  6. by ha Leaf-wall area for vertical crop EPPO PP 1/239 Herbicides : Splitting of the full dose ! F. Cors & B. Weickmans October 23, 2006 6

  7. F. Cors & B. Weickmans October 23, 2006 7

  8. 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 F. Cors & B. Weickmans October 23, 2006 8

  9. Biological dossier All original full trial reports should be added Trials should be clearly identified and referenced F. Cors & B. Weickmans October 23, 2006 9

  10. 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 F. Cors & B. Weickmans October 23, 2006 10

  11. 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 F. Cors & B. Weickmans October 23, 2006 11

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