Fees for processing applications
The tables below summarise the fees for clinical trials under the Directive and the Regulation. Fimea charges fees for applications under the Regulation on clinical trials.
Fees for clinical trials under the EU Clinical Trials Directive (2001/20/EC)
| New clinical trial | 3000 € |
| Amendments to a clinical trial | 1000 € |
A new clinical trial
| International clinical trial, Finland as reporting member state |
| The application concerns parts I and II (processing at the same time) | 6300€ /6600 € ATMP-product |
| The application concerns part I (processing separately) | 4300 € /4600 € ATMP-product |
| The application concerns part II (processing separately) | 2000 € |
| International clinical trial, Finland as a concerned member state (either in connection with the evaluation of the original application or when Finland is added as a concerned member state) |
| The application concerns parts I and II (processing at the same time) | 6300 € /6600 € ATMP-product |
| The application concerns part I (processing separately) | 4300 € /4600 € ATMP-product |
| The application concerns part II (processing separately) |
2000 € |
| National clinical trial, Finland as the reporting member state |
| The application concerns parts I and II (processing at the same time) | 6300 € /6600 € ATMP-product |
| The application concerns part I (processing separately) | 4300 € /4600 € ATMP-product |
| The application concerns part II (processing separately) |
2000 € |
Adding a new member state
| Adding a new member state, Finland as the reporting member state |
| The application concerns the addition of an EU member state as a new concerned member state, parts I and II at the same time | 1000 € |
Applications for modifications to clinical trials
| Modification in international clinical trial, Finland as a reporting member state |
| Applications for modifications concerns parts I and II (processing at the same time) | 2000 € |
| Applications for modifications concerns part I (processing separately) | 1300 € |
| Applications for modifications concerns part II (processing separately) | 700 € |
| Modification in international clinical trial, Finland as the concerned member state |
| Applications for modifications concerns parts I and II (processing at the same time) | 2000 € |
| Applications for modifications concerns part I (processing separately) | 1300 € |
| Applications for modifications concerns part II (processing separately) | 700 € |