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!

 

Dear Poonam,

After filled in the EXCEL file with the marketing status of our CAP, the EXCEL list was uploaded but we received following invalidation issues:

Row103:EU Number should be associated with Authorised Product,Marketing Status does not exists,Date of Marketing Status Change does not exists

Row125:EU Number should be associated with Authorised Product,Reason for Cessation does not exists,Does Cessation Lead to shortage does not exists,Date of Marketing Status Change does not exists

Row26:EU Number should be associated with Authorised Product

I followed the guidance to correctly filled in the EXCEl file (e.g. standard terms), I did not change the colu,mns or header!

Please advice how to solve the issues.

Thank you in advance!

KR,
Ben