The European Medicines Agency (EMA) has officially announced that starting from 1st January 2025, the current fee regulation (2024/568) will change. This implies that the fees and the payable charges will be updated. At the moment, EMA has issued a working arrangements document, which was adopted from June 2024, to:
- clarify the requirements and terminology of the new regulation;
- establish fee reductions for certain types of services;
- provide further details on payment modalities.
The key principles and objectives for the NFR are:
- Harmonization
- Flexibility
- Alignment
- Sustainability
During its periodic update webinar, EMA has shared some examples on the key changes for the orphan designation and pediatric submissions and for the scientific advice, certificates and parallel distribution submissions:
- Orphan Designation and Pediatric submissions: currently both procedures do not foresee the payment of any fee.
With the new regulation, some administrative fees will become applicable for applicants in two exceptional circumstances:
- If the applicant submits the application and withdraws it after 24 hours.
- If EMA rejects the application during the validation phase.
- Scientific Advice (SA), Certificates and Parallel Distribution submissions: currently, once the applicant applies for one of these services, EMA delivers the service and once the procedure is completed, the Agency issues the invoice for the applicant.
With the new fee regulation, once the applicant applies for the service, EMA first issues the invoice and once the payment is performed, they deliver the service. If EMA does not receive the payment within 30 days, the application is cancelled.
EMA is providing periodic updates on the timelines and procedures for the NFR implementation, to allow the companies to be ready for January 2025.
Regulatory Pharma Net provides full regulatory assistance during the whole product lifecycle and is ready to support companies on all regulatory needs and to guide them through any new EMA requirement/procedure including the new fees regulation.