Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018

News 18/10/2018

Pharmacovigilance fees payable to the European Medicines Agency by applicants and marketing authorisation holders increase by 1.7% as of 18 October 2018, to reflect the inflation rate adjustments of 2017.

All applications received by or having a data lock point (DLP) of 17 October 2018 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 2018/1298 amending Regulation (EU) No 658/2014 and the PDF icon Explanatory note on fees

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