Posted by Michael Wonder on 28 Mar 2018
EMA to raise MAH and applicant fees by 1.7% in April
28 March 2018 - As part of the EMA's alignment with the inflation rate, the agency announced on Tuesday that general, non-pharmacovigilance for applicants and marketing authorisation 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).
