Starting January 1, 2025, Regulation (EU) 2024/568 on EMA fees will take effect. Key updates include:
- Update of fee structures, calculated per procedure and based on actual costs incurred across Member States and EMA
- Pre-payment required for parallel distribution, certificates of medicinal products, and scientific advice.
- Introduction of administrative charges for withdrawal and for changes to the intended submission date
- Removal of certain fees (e.g., for Type I variations and renewals).
- Introduction of new fees (e.g., for PreSubmission, Referrals and re-examination of MA applications / opinions)
For details, visit: EMA NEW FEE REGULATION
For further questions, contact us at: [email protected]
