Dear All,
In Europe requirement for submission of minimum stability data at time of new submission is 6 month accelerated and 6 month long-term, thereafter we can provide additional data during the ongoing review process. However do any one has any experience if we submit new application with 3month acc/LT term data. Is it acceptable, with any justification ?
This 3 month data submission is only for 1 strength and for remaining strength we will submit complete data (upto the end of shelf life). -------------------------------------------
Ashish
Senior Regulatory Executive
United Kingdom -------------------------------------------