There is a decrease in variation application fees for marketing authorisations in so-called type IB variations
Drug Regulatory Fees Calculator
Is the change really worth it? What budget do I have to reserve for registering my variations? Is it financially more attractive to use a DCP rather than a CP? How do fees compare for countries acting as a reference member state in a mutual recognition procedure?
The first online regulatory fee calculator helps you answer these questions. With just a few clicks, it provides cost estimates for activities such as marketing authorisation applications or variations, across the European Economic Area (EEA).
Fee information from the regulatory authorities is checked biweekly and the database entries are updated with best price estimates. Additional advice such as price tolerances is added to the comments field. The service is currently free of charge and provided by Xendo Deutschland GmbH.
We provide the following information:
The calculator covers the EEA
The calculator is confined to human medicinal products
The following regulatory activities are covered: MAAs, Variations, Renewals, Line Extensions
Biopharmaceuticals are covered for the centralised procedure
Currencies are automatically converted into euros using exchange rates provided by the European Central Bank. Exchange rates for Iceland are updated every week
The database can be easily customized to include additional information
Please help us to improve this service. Feedback is warmly welcomed under contact.fees[at]xendo.com.
Help: Click here for user guidance.
News & Notes
EMA will increase the fees for all applications, except for pharmacovigilance procedures, by 0.2% to align with the 2015 inflation rate from 1 April 2016.