Posted Fri, 29 Nov 2024 11:08:36 GMT by Benjamin Vermeer Dr. rer. nat.

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!

 
Posted Fri, 29 Nov 2024 16:59:09 GMT by Paolo Tomasi EMA
Please consult the information available in the EMA website, which includes a Q&A document:  New Fee Regulation (from 1 January 2025) | European Medicines Agency (EMA). If you have remaining doubts, please submit your request via AskEMA: Send a question to the European Medicines Agency | European Medicines Agency (EMA).

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