From 1 April 2020, the general fees payable to the European Medicines Agency (EMA) by marketing authorisation holders and applicants has increased by 1.6%.
Each year, the EMA adjusts its fees in line with the EU inflation rate. Applications received by 31 March 2020 will be charged the old fee and reduction rate. The cut-off point for scientific advice and protocol assistance fees is the date of validation of the request for advice. Annual marketing authorisation fees will be charged according to the original date of the decision of the marketing authorisation. Any date falling on or after 1 April will be charged the adjusted fee.
Additionally, new fees have been introduced for consultations on medical devices in relation to human medicines.
It must be noted that this fee increase does not apply to pharmacovigilance activities. In accordance with Regulation (EU) 658/2014, pharmacovigilance fees are expected to be revised later in 2020.
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