en

Fees

In accordance with Act No 145/1995 as amended and Act No 362/2011 as amended, fees for applications submitted to SIDC are to be paid when submitting application.

SIDC sets fees for services according respective Acts which can be grouped under the categories listed below, details see in further text.

Fees are to be paid by bank transfer (EFT) from applicants account prior to submitting application and mandatory documentation as an enclosure to application. Payment procedure is part of eApplication.

Electronic allocation of variable symbol identification number which applicant is using for identifying when transferring respective fees for payable applications is part of eApplication. When respective fee is realised via bank transfer (EFT), applicant will receive electronically confirmation of payment from SIDC. Only if all requested procedural steps in eApplication are done (providing all mandatory data requested in eApplication with attached files and enclosure to eApplication is generated) other mandatory documentation and hard copy of application can be submitted to SIDC.

In the case of variations concerning several MA and/or several paid variations a cummulated fee is to be paid (i.e. final price is created by addinf of fees for all paid variation and MA within the Application).

Detailed information for using eApplication are described in Manual for eApplication and can be found in document User guide - Basic steps and hotline.

SIDC representing Slovak Republic as CMS or RMS, sets fees for services according respective Acts which can be grouped under the following categories:

 

Activity
Fee
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


How to pay

Fees are to be paid by bank transfer from applicants account prior to submitting application and mandatory documentation as an enclosure to application. Payment procedure is part of eApplication.

Payment instruction for SEPA payments* in EUR

Bank: Štátna pokladnica
Radlinského 32
810 05 Bratislava
Slovenská republika
 
BIC/SWIFT:     SPSRSKBAXXX
IBAN: SK34 8180 0000 0070 0013 3673
Country code: SK
Remittance information: Variable symbol generated by eApplication procedure

 

Payment instruction for payments

  • from countries apart from SEPA area
  • in another currency as EUR
Bank: Všeobecná úverová banka, a.s.
Mlynské Nivy 1
829 90 Bratislava
Slovenská republika
 
BIC/SWIFT:     SUBASKBX
IBAN: SK34 8180 0000 0070 0013 3673
Country code: SK
Remittance information: Variable symbol generated by eApplication procedure

IMPORTANT INFORMATION:

1) PLEASE, refer to variable symbol – identification number generated by eApplication procedure in order to identify the payment.
2) PLEASE, remember to realise bank transfer per every generated Variable Symbol separately. Cummulative payments (more Variable Symbols under one payment) will not be accepted.

 

* SEPA pyments are payments in EUR from SEPA area (states of the European Economic Area+ Iceland, Norway, Liechtenstein plus Switzerland and Monaco). .
* SEPA is aimed to unify rules and standards in the implementation of cashless euro payments within the EU countries. SEPA will enable to make and receive payments within the SEPA single area under equal technical and business terms and conditions, while it will remove differences between foreign and domestic payments, i.e. all the payments within the SEPA area will be deemed domestic ones.
Print page
eu-flag.png sk-flag.png