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If you are interested in getting updates about any changes and developments in CIS registration system and requirements, subscribe to our newsletter and we will keep you posted. We promise to stick to regulatory issues and you will never receive any commercials, promotions and stuff like that. News will be sent approximately once per one-two month.
Changes in the requirements to conducting mutagenicity and subchronic toxicity studies for registration in Russia
14.09.2017
Currently, according to the data provided by the experts of Rospotrebnadzor’s Federal Scientific Centre of Hygiene n.a. F.F. Erisman, mutagenicity and subchronic toxicity studies of an active ingredient are not required for the registration of plant protection products in Russia . However, in this case full report of 5-batch analysis must be submitted to prove the equivalence of technical material (active ingredient) to originator’s.
To prolong existing registrations, one of the following requirements should be met:
• An applicant should conduct mutagenicity and subchronic toxicity studies of the active ingredient;
• Or provide 5-batch analysis report and confirm technical material’s chemical equivalence.