Regulatory information – adjusted fees for pharmacovigilance applications to EMA from January 2018

News 20/12/2017

Pharmacovigilance fees expected to increase by 1.4%

The European Medicines Agency reminds applicants and marketing authorisation holders that adjusted fees for pharmacovigilance applications are expected to come into effect in mid-January 2018.

The European Commission adopted a regulation adjusting the pharmacovigilance fees payable to the Agency on 18 October 2017. Following a two-month consultation with the Council and Parliament, the amended regulation is expected to be published in January 2018. Since pharmacovigilance fees were not adjusted in 2016 to reflect the 2015 inflation rate of 0.2%, this increase is added to the 2016 inflation rate adjustment of 1.2%, resulting in a total increase of 1.4%.

The Agency will publish full details of the revised fees in January 2018, once the consultation period ends, and the amended regulation is published in the Official Journal of the European Union.

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