The risk evaluation process now required as of October 1, 2020, corresponds to Step 1 (Step 1 conduct of risk evaluation) of the three-step process specified by the EMA. The results are reported back to the agency by the marketing authorisation holders using one of the two corresponding templates:
A detailed description of all requirements and access to the templates of steps 1, 2 and 3 can be found here.
In the course of this process, the EMA has updated the 11-page Q&A document for MAHs. The following Q&As have been revised:
Click here to view the Q&A document.
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