Regulatory information – adjusted fees for pharmacovigilance applications from 3 October 2022

News 30/09/2022

Pharmacovigilance fees payable to the European Medicines Agency by applicants and marketing authorisation holders increase by 5.6% as of 3 October 2022, to reflect the inflation rate adjustments of 0.3% in 2020 and 5.3% in 2021.

All applications received by or having a data lock point (DLP) of 3 October 2022 will be charged the current fee and reduction rates. Applications received or having a DLP after that date will be charged the adjusted rates.

Further details of the new fee levels are available in the Commission Delegated Regulation (EU) No 2022/1520 amending Regulation (EU) No 658/2014 and the related document on PDF icon Explanatory note on fees .

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