EDQM review of CEP applications for sartans and next steps (June 2019): update

18 juin 2019

BlueRegWatch

The EDQM has now finalised the review and update of the vast majority of CEP dossiers for sartans containing a tetrazole ring structure.
The CEP dossiers have been assessed following a risk- and science-based approach. When sufficient data was given to demonstrate that there were no risks of presence of nitrosamines and a limit in the specification of the active substance was not necessary (based on the process and an appropriate control strategy), the CEP was not revised but a letter of approval was sent to the CEP holder instead.

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