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.
Booking of slots with a choice of RMS for marketing authorization application via slot booking process
Support in MAA Pre-submission meeting and pre-submission administrative activities including slot booking
Request the HA to act as RMS and book the slot for submission
Liaise with RMS in case of submission through DCP/MRP procedures