EMA to Raise MAH and Applicant Fees by 1.7% in April

Regulatory NewsRegulatory News | 28 March 2018 |  By 

As part of the European Medicines Agency’s (EMA) alignment with the inflation rate, the agency announced on Tuesday that general, non-pharmacovigilance for applicants and marketing authorization holders are increasing by 1.7% on 1 April 2018.

“All applications received by 31 March will be charged the current fee and reduction rates. Applications received after that date will be charged the adjusted fees,” EMA said. “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 authorisation defines the applicable fee and consequently a new fee will be applicable at the time of any anniversary on or after 1 April 2018.”

The basic fee for an application for which a full dossier needs to be presented will rise to €286,900 (from €282,100), and for an application for which a dossier does not need to be presented, the fee will rise to €185,500 (from €182,400).

Initial requests for scientific advice now range from €43,000 to €86,100.

Explanatory note on general fees payable to the European Medicines Agency


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy