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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

Fees for Slovenia updated

Updated fees for JAZMP are now available in our database.

12.04.2017

Fees for UK now paid on receipt of invoice

As of 01.04.2017 fees for the UK are paid on receipt of invoice and no longer in advance.

12.04.2017

Fees for Iceland updated

Updated fees for IMCA are now available in our database. Only increases in RMS related fees.

11.04.2017

Fees for application to EMA updated from 1 April 2017

EMA increased the fees for all applications, except for pharmacovigilance procedures, by 1.2% to align with the 2016 inflation rate, from 1 April 2017

04.04.2017