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Fees for drug registrations connected to the amendment of the Act on Administrative fees

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

 

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