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The European Commission, Directorate-General for Health and Food Safety (DG SANTE) is undertaking an impact assessment (IA) of the EMA fee system. The objectives of the Commission IA are to assess the impacts of a set of proposed options aimed at:

• Aligning the main categories of fees and charges with the EMA Founding Regulation,
• Allowing for adequate financing of veterinary procedures,
• Achieving a simplification of the system, and
• Ensuring a fair distribution of fees and NCA remuneration, while respecting fee incentives set in existing policies.

A study has been commissioned to support the impact assessment, which is being led by ICF and RAND Europe. This site has been developed to support the targeted consultation for the impact assessment study.

This site contains all of the relevant background information on the work carried out from the end of the evaluation phase until the present study, including supporting material for the consultation.

The targeted consultation will run from 14 June to 9 August 2021.

The study team is compiling a list of frequently asked questions, which will be updated as the consultation progresses. You can find the latest FAQs here.

For any queries, please contact: EMAFeeSystem_Study@icf.com