Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018
NewsHumanCorporatePharmacovigilance
The European Medicines Agency (EMA) would like to inform applicants and marketing authorisation holders that adjusted fees for pharmacovigilance applications are expected to come into effect as of 18 October 2018.
The European Commission has adopted a regulation adjusting the pharmacovigilance fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2017 inflation rate was 1.7%. Following a two-month consultation with the Council and the Parliament, the amended regulation was published today (28 September) in the Official Journal of the European Union.
The Agency will publish full details of the revised fees on 18 October 2018, once the new fees come into force.