How many months of long-term and accelerated data are required when a “Completeness Assessment” is performed on the DMF? Also, what should the DMF stability section contain for a Completeness Assessment?

To pass the Completeness Assessment, DMFs should include the stability
protocol, commitments, and data demonstrating that stability studies have
started. The initial and one additional time point for the accelerated studies
and long-term studies are sufficient. If the DMF does not meet the
recommendations under A1(ii) below at the time of the Completeness
Assessment the DMF holder should amend the DMF with updated stability
data to prepare for full scientific review.