Fees for drug registrations connected to the amendment of the Act on Administrative fees
Obsah
Since October 1st, 2012 has come into force the amendment of the Act on Administrative fees No. 145 of 1995 Coll., as subsequently amended, which regulates payments for marketing authorizations, variations, transfers and renewals in drug registrations.
According to the amendment the new fees have been updated in an electronic system eApplication where applicants generate variable symbol for service payments.
State Institute for Drug Control draws attention to the list of administrative fees in registration process which can be viewed below:
Fees
Application for Marketing Authorisation, national procedure
|
Article 8(3) application - new active substance |
9 600,00 € |
|
Article 8(3) application - known active substance |
8 000,00 € |
|
Article 10a well established use application |
6 400,00 € |
|
Article 10(1) generic application |
8 000,00 € |
|
Article 10(3) hybrid application |
8 500,00 € |
|
Article 10b fixed combination application |
8 000,00 € |
|
Article 10c informed consent application |
3 000,00 € |
|
homeopathic medicinal products - full application |
8 000,00 € |
|
Article 14 homeopathic med. products - simplified registration |
6 400,00 € |
|
Article 16a traditional use registration for herbal medicinal product |
6 400,00 € |
|
Additional strength, or pharmaceutical form |
2 000,00 € |
Application for Marketing Authorisation , MRP/DCP – CMS
|
Article 8(3) application - new active substance |
6 000,00 € |
|
Article 8(3) application - known active substance |
5 000,00 € |
|
Article 10a well established use application |
4 000,00 € |
|
Article 10(1) generic application |
5 000,00 € |
|
Article 10(3) hybrid application |
5 500,00 € |
|
Article 10b fixed combination application |
5 000,00 € |
|
Article 10c informed consent application |
2 000,00 € |
|
homeopathic medicinal products - full application |
5 000,00 € |
|
Article 14 homeopathic med. products - simplified registration |
4 000,00 € |
|
Article 16a traditional use registration for herbal medicinal product |
4 000,00 € |
|
Additional strength, or pharmaceutical form |
2 000,00 € |
Application for Marketing Authorisation, MRP/DCP – RMS
|
Article 8(3) application - new active substance |
11 000,00 € |
|
Article 8(3) application - known active substance |
9 000,00 € |
|
Article 10a well established use application |
7 200,00 € |
|
Article 10(1) generic application |
9 000,00 € |
|
Article 10(3) hybrid application |
9 600,00 € |
|
Article 10b fixed combination application |
9 000,00 € |
|
Article 10c informed consent application |
3 500,00 € |
|
homeopathic medicinal products - full application |
9 000,00 € |
|
Article 14 homeopathic med. products - simplified registration |
7 500,00 € |
|
Article 16a traditional use registration for herbal medicinal product |
7 500,00 € |
|
Additional strength, or pharmaceutical form |
2 000,00 € |
Renewal
|
National procedure |
5 000,00 € |
|
DCP/MRP - CMS |
4 000,00 € |
|
DCP/MRP - RMS |
5 000,00 € |
Type II Variations
|
National procedure |
4 000,00 € |
|
DCP/MRP - CMS |
3 200,00 € |
|
DCP/MRP - RMS |
5 000,00 € |
|
Additional strength |
200,00 € |
Type 1A, 1B Variations
|
National procedure |
200,00 € |
|
DCP/MRP - CMS |
200,00 € |
|
DCP/MRP - RMS |
200,00 € |
|
MAH Transfer |
500,00 € |
|
Article 61 (3) Directive 2001/83/EC |
Not payable application |