From January 1st, 2025 a new EU regulation comes into effect, REGULATION (EU) 2024/568
"REGULATION (EU) 2024/568 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 February 2024 on fees and charges payable to the European Medicines Agency, amending Regulations (EU) 2017/745 and (EU) 2022/123 of the European Parliament and of the Council and repealing Regulation (EU) No 658/2014 of the European Parliament and of the Council and Council Regulation (EC) No 297/95".
These includes for example, a change to the markeing authorization application (MAA) submission timeline more than 60 days will have an associated fee.
My questions:
Does this fee change also apply if you submit the MAA early due to a stop for efficacy?
Thank you very much in advance for your response / thoughts!