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Implementation of resistance risk analysis of plant protection products in the German authorisation procedure

机译:德国授权程序植物保护产品抵抗风险分析的实施

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The final version of the EPPO standard PP 1/213(1) on resistance risk analysis will form the basis for risk assessment within the authorisation process in Germany. Data for resistance risk analysis have to be provided by the applicant and risk mitigation strategies have to be prepared. The extent of data requirements and the intensity of the evaluation process depends mainly on the type of harmful organism, crop, mode of action of the active substance and the resistance history of the organism in combination with products of similar mode of action as the one being applied for. An intensive co-operation between applicants and regulators is essential prior to the submission of the dossier with consideration of the amount of data necessary and where required the resistance management strategy proposed.
机译:EPPO标准PP 1/213(1)的最终版本抵抗风险分析将为德国授权过程中的风险评估构成基础。申请人必须提供抵抗风险分析数据,并且必须准备风险缓解策略。数据要求的程度和评估过程的强度主要取决于有害生物,作物,活性物质的作用方式以及生物体的抵抗史与类似的动作模式的抗性历史相结合应用于。申请人和监管机构之间的密集合作是在提交档案的情况下,考虑到所需的数据量以及所需的抵抗管理策略提出的数据。

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