Pharmacovigilance fees

From 12 February 2018, there has been a 1.4% increase in the fees payable for pharmacovigilance activities to the EMA. This increase is due to inflation in 2015 and 2016. Please see the EMA press release.

Types of fee

There are two types of fee covered by Regulation (EU) No 658/2014, (the ‘Pharmacovigilance Fee Regulation’).

Procedure-based fees

  • fee for the EU single assessment of periodic safety update reports (PSURs);
  • fee for post-authorisation safety studies (PASSs) protocols and study results;
  • fee for pharmacovigilance-related referrals.

Annual fee (for nationally authorised medicines):

This is for:

  • information technology systems (especially the maintenance of the Eudravigilance database);
  • monitoring of selected medical literature.

Annual fees related to centrally authorised medicines are already covered by fee Regulation (EC) No 297/95. Further information can be found in the explanatory note published by the EMA.

What EUDRAC can do to help?

EUDRAC provides a complete PV service for its clients and also provides support for clients’ existing PV systems, including signal detection. In addition, we keep clients up-to-date on the rapidly changing PV environment through our Global PV intelligence service. For more information on pharmacovigilance services, please contact us here.