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My understanding is that the EMA review has been stopped at the...

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    My understanding is that the EMA review has been stopped at the 180 day point.

    The SAWP procedure is a sub program of review where EMA approved authorities sit down with TIS and define the parameters of the scientific testing that is required. If the testing is conducted as per the defined program, and meets the defined assessment criteria to the satisfaction of the SAWP expert, then the EMA panel has to accept the findings of the SAWP review.
 
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