Phase I: eApplication submission - information
1. General informationSIDC informs all Marketing Authorisation Applicants/Holders that from September 7, 2009 new electronic system of submission is to be launched - Phase I: eApplication submission.
The main aim of new system eApplication is: 1) electronic allocation of variable symbol - identification number which applicant is using for identifying when transferring fees for payable applications
2) electronic tracking of transfers of fees for payable applications
3) to obtain and use specific standard data from applications in electronic form
Applications with variable symbol already allocated till September 4, 2009 (prior to been electronically allocated by new system from September 7, 2009) will be proceeded without any change.
2. Fees payable to SIDCIn 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 in table 1, 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:
Table 1
3. How to payFees 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. Bank connection valid from 1th February 2014 Payment instruction for SEPA payments* in EUR
Payment instruction for payments
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.
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