EMA fees to increase by 1.7% from 1 April 2019

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.

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Published 9. April 2019 in News, News EU