Regulatory information – adjusted fees for pharmacovigilance applications to EMA from 12 February 2018

News 12/02/2018

Pharmacovigilance fees increase by 1.4%

Pharmacovigilance fees payable to the European Medicines Agency (EMA) by applicants and marketing authorisation holders increase by 1.4% as of 12 February 2018, to reflect inflation rate adjustments of 0.2% for 2015 and 1.2% for 2016.

All applications received by or having a data lock point (DLP) of 11 February 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 Commission Delegated Regulation (EU) 2018/92 amending Regulation (EU) No 658/2014 and the PDF iconexplanatory note on fees .

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