Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018

October 18, 2018 – Pharmacovigilance fees payable to the European Medicines Agency by applicants and marketing authorisation holders increase by 1.7% as of 18 October 2018, to reflect the inflation rate adjustments of 2017. All applications received by or having a data lock point (DLP) of 17 October 2018 will be charged the current fee and reduction rates. Applications received or having a DLP after that date will be charged the adjusted rates. Further … (leggi tutto)