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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 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)