The European Medicines Agency (EMA) has announced that fees payable by applicants and marketing authorisation holders are increasing by 1.7% from 1 April 2019.
The increase reflects the current inflation rate of the EU (the EMA annually increasing its fees to reflect this).
The EMA announcement notes that:
- all applications received by 31 March 2019 will continue to be charged the current rate
- for scientific advice and protocol assistance the cut-off point will be the date of the validation of the request for advice
- for annual fees, the anniversary date of the decision granting the marketing authorisation defines the applicable fee (a new fee will be applicable following the anniversary after the 1 April 2019)
- fees charged for pharmacovigilance procedures are expected to be revised in 2020
Further information regarding these changes can be found here.