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Regulatory Focus™ > News Articles > 7 > EU Pharmacovigilance Fees Rise 1.7 Percent

EU Pharmacovigilance Fees Rise 1.7 Percent

Posted 12 July 2018 | By Michael Mezher 

EU Pharmacovigilance Fees Rise 1.7 Percent

The European Commission on Wednesday raised the fees pharmaceutical companies pay related to pharmacovigilance activities in the EU by 1.7% to keep pace with inflation in 2017.

Pharmacovigilance fees in the EU are set by Regulation (EU) No 658/2014, which includes provisions for the European Commission to adjust the fees to keep up with the rate of inflation as measured by the European Index of Consumer prices.

The fees were last increased in February by 1.4% after not increasing in 2017 due to low levels of inflation to account for the combined inflation rate over 2015 and 2016.

For drugmakers, this translates to a fee increase of 1.7% rounded to the nearest €10 for all pharmacovigilance fees except for the annual fee for IT systems and literature monitoring, which are rounded to the nearest €1.


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