Regulatory Focus™ > News Articles > EMA Decides to Waive User Fees for Certain Pharmacovigilance Reporting Events

EMA Decides to Waive User Fees for Certain Pharmacovigilance Reporting Events

Posted 31 July 2013 | By Alexander Gaffney, RAC 

Newly revised user fees are set to come into effect next week in the EU for certain pharmacovigilance reporting forms, the European Medicines Agency (EMA) has announced, providing a substantial benefit to members of industry.

The user fees relate to Type IA variation forms used to immediately report major pharmacovigilance events, including:

  • the introduction of a pharmacovigilance monitoring system for a product
  • changes made to an existing pharmacovigilance monitoring system
  • a change in the frequency of submission of periodic safety update reports (PSURS)
  • the inclusion or deletion of a "black symbol" to a product or new statements added to products subject to enhanced monitoring procedures
  • new statements with respect to adverse drug events (ADEs)

The good news for sponsors, however, is that EMA has decided to fully waive the entire fee for all of the aforementioned Type IA variation form submissions. Such exemptions will reportedly apply whether or not the notifications were done individually, grouped, or combined into another application.


Revised EMA Guidance on User Fees (Page 35/36)

EMA Statement


Tags: EU

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