Primary source: Download medicine data | European Medicines Agency (EMA)
The application of fee calculations and payment modalities under the New Fee Regulation (Regulation (EU) 2024/568) has been clarified, including new reduction criteria for SMEs and public health products.
This update ensures that marketing authorization holders (MAHs) and small and medium-sized enterprises (SMEs) have a clear understanding of the fee structures, facilitating better financial planning for mandatory pharmacovigilance activities.
MAHs and SMEs must review the updated fee structures and assess the potential for fee reductions on safety-related submissions to align with the new regulatory framework.
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Clarifications on fee calculations under Regulation (EU) 2024/568; updated payment modalities; refined reduction criteria for SMEs and public health products.
The update provides necessary clarity for the financial planning of mandatory PV activities such as Periodic Safety Update Report Single Assessments (PSUSAs) and Post-Authorisation Safety Study (PASS) protocols. It ensures that MAHs and SMEs understand the fee structures and potential reductions for safety-related submissions under the new regulatory framework.
MAHs and SMEs must review the updated fee structures and assess the potential for fee reductions on safety-related submissions to align with the new regulatory framework.
The guidance document on fees payable to the European Medicines Agency was updated to reflect the application of the New Fee Regulation (Regulation (EU) 2024/568). This includes details about fee calculations, payment modalities, and reductions applicable to safety-related submissions, essential for mandatory pharmacovigilance activities like Periodic Safety Update Reports and Post-Authorisation Safety Study protocols.
What changed: The application of fee calculations and payment modalities under the New Fee Regulation (Regulation (EU) 2024/568) has been clarified, including new reduction criteria for SMEs and public health products.
Why it matters: This update ensures that marketing authorization holders (MAHs) and small and medium-sized enterprises (SMEs) have a clear understanding of the fee structures, facilitating better financial planning for mandatory pharmacovigilance activities.
Practical implication: MAHs and SMEs must review the updated fee structures and assess the potential for fee reductions on safety-related submissions to align with the new regulatory framework.
Published from the Firecrawl policy change extraction pipeline.
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