From 12 February 2018, there has been a 1.4% increase in the fees payable for pharmacovigilance activities to the EMA. This increase is due to inflation in 2015 and 2016. Please see the EMA press release.
There are two types of fee covered by Regulation (EU) No 658/2014, (the ‘Pharmacovigilance Fee Regulation’).
This is for:
Annual fees related to centrally authorised medicines are already covered by fee Regulation (EC) No 297/95. Further information can be found in the explanatory note published by the EMA.
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