On 1 January 2025, Regulation (EU) 2024/568 on fees and charges payable to the European Medicines Agency ('New Fee Regulation' (“NFR”)) came into force.

The Agency invites all human industry stakeholders to a questions and answers session on the regulatory and system changes resulting from the introduction of this regulation (e.

g.

, the introduction of the new Certificates processing System or CPS).

Ahead of the session, we encourage you to consult the following materials: Regulation (EU) 2024/568Questions and answers on NFRFee Regulation Working ArrangementsGuidance on how to pay fees to EMAGuidance on how to request Certificates via the new CPSPlease note: technical questions related to any other system changes or platforms (e.

g.

, IRIS) except for CPS are outside the scope of this session.