Every year, the European Medicines Agency (EMA) adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year.
On 1 April 2018 general, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders (MAH) are increasing by 1.7%.
Applications received after the 31 March 2018 will be charged the adjusted fees.
- For scientific advice and protocol assistance: the cut-off point will be the date of validation of the request for advice.
- For annual fees: the anniversary date of the decision granting the marketing authorization (MA) defines the applicable fee.
Fees charged for pharmacovigilance procedures will be revised in the second half of the current year.
Example of payable fees:
|Fee type||Human medicines||Veterinary medicines|
|MA application (single strength, one pharmaceutical form, one presentation)||From €286,900||From €143,700|
|Extension of MA (level I)||€86,100||€35,900|
|Type-II variation (major variation)||€86,100||€43,000|
|Scientific advice||From €43,000 to €86,100||From €14,200 to 43,000|
|Annual fee (level I)||€102,900||€34,400|
Commission Regulation (EU) 2018/471 of 21 March 2018, amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2018.