Submission Slot Booking

Overview

Marketing Authorization Holder (MAH), planning to submit the MAA through any of the Regulatory procedures should check for available dates with the European Medicines Agency (EMA) or with a reference Member State to understand the submission timelines and get confirmation for the submission. The MAH should submit the MAA on the allotted slot to HAs. Delay in the submission should be communicated with HA well in advance. Slot booking should be performed a few months before the planned submission timelines. Freyr can help the MAHs with slot booking and do necessary correspondence with HAs for any required clarification.