en

Fees

August 2024

 

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 an application. 

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

A fee is to be paid by bank transfer (EFT) from the applicant‘s account prior to submitting an application and mandatory documentation as an enclosure to the application.

In the case of variations concerning several MAs and/or several paid variations, a cummulated fee is to be paid (i.e. final price is created by adding of fees for all paid variations and MAs within the application).

In the case of an incorrectly paid administrative fee, for example with a different variable symbol or in the wrong amount, it is necessary to submit an Application for the refund of the administrative fee. More information can be found here.

Movements/movement of correct charges between variable symbols is not possible.

The operator of eKolok services is Slovenská pošta a.s., which means they are in charge of processing the payments themselves. In case you have sent the payment with incorrect data, contact the Slovak Post (ekolky@slposta.sk  or phone number +421 48 437 87 77, infoline: 18 666, more contacts can be found here).

 

Please make the payment using one of the options below

 a) by purchasing a Receipt of Payment of Administrative Fee (e-Revenue Stamp) at the offices of Slovak Post (Slovenská pošta)

            The Receipt of Payment of Administrative Fee (e-Revenue Stamp) is required in paper form as an original.

            The Receipt of Payment of Administrative Fee (e-Revenue Stamp)  purchased at Slovak Post offices is valid for 2 years.

 b) via e-Revenue Stamp Web Application, also called Virtual Kiosk

In the first step, the payer is required to register in the system on the website https://m.ekolky.gov.sk . We recommend that you read the user manual for the e-Revenue Stamp web application, which you can find on the website www.posta.sk/en , select "Government Services“, then select „e-Revenue Stamp Payment System,". At the bottom of webpage you can find the relevant manual in the PDF format („Príručka pre webovú aplikáciu eKolok“). The manual is available in Slovak only at the moment.

After registration, you can purchase the e-Revenue Stamp by selecting „Úhrada poplatku online" (Payment of the fee online) and entering the service ID (enter the four-digit service code, as per instructions below)

 

 

The confirmation purchased in this way via the web application eKolok - Virtual kiosk must be attached to the application and documentation.

NOTE: The Receipt of Payment of Administrative Fee purchased through the Web Application is valid for only 30 days. For this reason, we kindly suggest that you make the payment only after you have completed all the necessary documents.

 c) Payment of the fee based on the Payment Instruction issued by the SIDC

In case that the administrative fee has not been paid and the confirmation of payment with a QR code has not been attached to the applications and documentation, a Payment Instruction will be issued for your application, which will be found in the attachment of the notification e-mail.

We ask you to make the payment no later than the day indicated on the Payment Instruction, since the legal deadline for processing applications starts running from the date of completion of the payment of the administrative fee and the evaluation of the procedure will begin when the application is complete/paid.

 

IMPORTANT!!!: 

When making the payment, please do not forget to indicate the correct Variable symbol (VS).  For non-cash payments from abroad, it is necessary to specify the E2E reference code in an identical form (number of characters, slashes) as displayed on your Payment Instruction.

This is important so that your payment can be matched with the Payment Instruction for the fee and afterwards your service request can be processed.

In case of an incorrect VS or payment of an expired Payment Instruction, your payment will be returned to you.

Registration Section

service ID

The name of the administrative fee

the amount of the administrative fee

7408

96.1.9. Issuing a Decision on a Stand Alone Marketing Authorisation Application - full dossier - new active substance

                           9 600,00 €

7409

96.1.10. Issuing a Decision on a Stand Alone Marketing Authorisation Application - full dossier - known active substance

                           8 000,00 €

7410

96.1.11. Issuing a Decision on a Well-established Use Marketing Auhtorisation Application - scientific literature

                           6 400,00 €

7411

96.1.12. Issuing a Decision on a Generic Marketing Authorisation Application

                           8 000,00 €

7412

96.1.13. Issuing a Decision on a Hybrid Marketing Authorisation Application

                           8 500,00 €

7413

96.1.14. Issuing a Decision on a New Fixed Combination Marketing Authorisation Application

                           8 000,00 €

7414

96.1.15. Issuing a Decision on an Informed Consent Marketing Authorisation Application

                           3 000,00 €

7415

96.1.16. Issuing a Decision on a Homepathic Marketing Authorisation Application - full dossier or scientific literature

                           8 000,00 €

7416

96.1.17. Issuing a Decision on a Homepathic Marketing Authorisation Application - simplified procedure

                           6 400,00 €

7417

96.1.18. Issuing a Decision on a Traditional Use Registration for Herbal Medicinal Product

                           6 400,00 €

7418

96.1.19. Issuing a Decision on a Marketing Authorisation Application for each additional strength or pharmaceutical form

                            2 000,00 €

7419

96.1.20. Issuing a Decision on a DCP / MRP Stand Alone Marketing Authorisation Application - full dossier - new active substance - SK is CMS

                            6 000,00 €

7420

96.1.21. Issuing a Decision on a DCP / MRP Stand Alone Marketing Authorisation Application - full dossier - known active substance - SK is CMS

                           5 000,00 €

7421

96.1.22. Issuing a Decision on a DCP / MRP Well-established Use Marketing Auhtorisation Application - scientific literature - SK is CMS

                           4 000,00 €

7422

96.1.23. Issuing a Decision on a DCP / MRP Generic Marketing Authorisation Application - SK is CMS

                           5 000,00 €

7423

96.1.24. Issuing a Decision on a DCP / MRP Hybrid Marketing Authorisation Application - SK is CMS

                           5 500,00 €

7424

96.1.25. Issuing a Decision on a DCP / MRP New Fixed Combination Marketing Authorisation Application - SK is CMS

                           5 000,00 €

7425

96.1.26. Issuing a Decision on a DCP / MRP Informed Consent Marketing Authorisation Application - SK is CMS

                           2 000,00 €

7426

96.1.27. Issuing a Decision on a DCP / MRP Homepathic Marketing Authorisation Application - full dossier or scientific literature - SK is CMS

                           5 000,00 €

7427

96.1.28. Issuing a Decision on a DCP / MRP Homepathic Marketing Authorisation Application - simplified procedure - SK is CMS

                           4 000,00 €

7428

96.1.29. Issuing a Decision on a DCP / MRP Traditional Use Registration for Herbal Medicinal Product - SK is CMS

                           4 000,00 €

7429

96.1.30. Issuing a Decision on a DCP / MRP Marketing Authorisation Application for each additional strength or pharmaceutical form - SK is CMS

                           2 000,00 €

7430

96.1.31. Issuing a Decision on a DCP / MRP Stand Alone Marketing Authorisation Application - full dossier - new active substance - SK in RMS

                        11 000,00 €

7431

96.1.32. Issuing a Decision on a DCP / MRP Stand Alone Marketing Authorisation Application - full dossier - known active substance - SK is RMS

                           9 000,00 €

7432

96.1.33. Issuing a Decision on a DCP / MRP Well-established Use Marketing Auhtorisation Application - scientific literature - SK is RMS

                           7 200,00 €

7433

96.1.34. Issuing a Decision on a DCP / MRP Generic Marketing Authorisation Application - SK is RMS

                           9 000,00 €

7434

96.1.35. Issuing a Decision on a DCP / MRP Hybrid Marketing Authorisation Application - SK is RMS

                           9 600,00 €

7435

96.1. 36. Issuing a Decision on a DCP / MRP New Fixed Combination Marketing Authorisation Application - SK is RMS

                           9 000,00 €

7436

96.1.37. Issuing a Decision on a DCP / MRP Informed Consent Marketing Authorisation Application - SK is RMS

                           3 500,00 €

7437

96.1.38. Issuing a Decision on a DCP / MRP Homepathic Marketing Authorisation Application - full dossier or scientific literature - SK is RMS

                           9 000,00 €

7438

96.1.39. Issuing a Decision on a DCP / MRP Homepathic Marketing Authorisation Application - simplified procedure - SK is RMS

                           7 500,00 €

7439

96.1.40. Issuing a Decision on a DCP / MRP Traditional Use Registration for Herbal Medicinal Product - SK is RMS

                           7 500,00 €

7440

96.1.41. Issuing a Decision on a DCP / MRP Marketing Authorisation Application for each additional strength or pharmaceutical form- SK is RMS

                           2 000,00 €

7441

96.1.42. Issuing a Decision on a Marketing Authorisation Renewal Application

                           5 000,00 €

7442

96.1.43. Issuing a Decision on a DCP / MRP Marketing Authorisation Renewal Application - SK is CMS

                           4 000,00 €

7443

96.1.44. Issuing a Decision on a DCP / MRP Marketing Authorisation Renewal Application - SK is RMS

                           5 000,00 €

7444

96.1.45. Acknowledgement of an Approval / Refusal of IA / IB Notification

                         200,00 €

7445

96.1.46. Acknowledgement of an Approval / Refusal of DCP / MRP IA / IB Notification - SK is CMS

                         200,00 €

7446

96.1.47. Acknowledgement of an Approval / Refusal of DCP / MRP IA / IB Notification - SK is RMS

                         200,00 €

7447

96.1.48. Issuing a Decision on a Type II Variation Application

                           4 000,00 €

7448

96.1.49. Issuing a Decision on a Type II Variation Application for each additional strength

                         200,00 €

7449

96.1.50. Issuing a Decision on a MRP / DCP Type II Variation Application - SK is CMS

                           3 200,00 €

7450

96.1.51. Issuing a Decision on a MRP / DCP Type II Variation Application - SK is CMS - for each additional strength

                         200,00 €

7451

96.1.52. Issuing a Decision on a MRP / DCP Type II Variation Application - SK is RMS

                           5 000,00 €

7452

96.1.53. Issuing a Decision on a MRP / DCP Type II Variation Application - SK is RMS - for each additional strength

                         200,00 €

7600

96.1.54. Issuing a Decision on a Marketing Authorisation Transfer Application

                         500,00 €

 

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