State Institute for Drug Control

This guideline supersedes guideline UST- 29 version 8 effective as of 3 June 2011.

UST-29_version_9, soubor typu pdf, (243.91 kB)

Introduction

The guideline is being issued in compliance with the provisions of Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended (hereinafter referred to as  the “Act on Pharmaceuticals“), of Act No 48/1997 Coll., on Public Health Insurance and on Amendments to Some Related Acts (hereinafter referred to as the “Act on Public Health Insurance”), of Act No 634/2004 Coll., on Administrative Fees, as amended (hereinafter referred to as the “Act on Administrative Fees“), of Act No 106/1999 Coll., on Free Access to Information, as amended (hereinafter referred to as the “Act on Free Access to Information“), of Act No 257/2001 Coll., on Libraries, as amended (hereinafter referred to as the “Act on Libraries”) and of Act No 218/2000 Coll., on Budgetary Rules, as amended (hereinafter referred to as the “Act on Budgetary Rules“).

 

The State Institute for Drug Control (hereinafter referred to as  “SÚKL“) has, within the scope of a revision of guideline UST-29, amended the possibility of discount for micro, small and medium enterprise for items in the Pricelist of reimbursements of costs of expert activities and annual maintenance fees pursuant to Decree No 427/2008 Coll., stipulating the amounts of reimbursement of costs of expert  activities conducted within the scope of powers of the State Institute for Drug Control and the Institute for the State Control of Veterinary Biologicals and Medicaments and the process when the duty of annual maintenance fee payment pursuant to Act No. 112 Decree No 378/2007 Coll., on Pharmaceuticals, is not fulfilled.

 

1           Payment of administrative fees

1.1          Procedure to be applied in the payment of administrative fees

Pursuant to the provisions of the Act on Administrative Fees, applicants shall be obliged to pay administrative fees for the submission of applications. 

 

 

Administrative fees shall be paid by bank transfer.

 

The variable symbol of the payment may be obtained by the applicant using interactive forms:

a)       The form for the payment of administrative fees covering the costs of expert activities conducted upon request is available from http://www.sukl.cz/modules/sukl/payment.php, section Pricelist and Fees.

b)       Forms for individual activities available from http://www.sukl.cz/pokyny-a-formulare-10, section SÚKL activities – Price and reimbursement rating for pharmaceuticals shall be used for the payments of administrative fees for applications for the determination of maximum manufacturer's price and/or amount and conditions of reimbursement of a medicinal product or foods for special medical purposes.  

 

In the interactive form, the applicant shall complete the required data relevant to the application. Once these are posted (from the web) to the administrative authority, the “Proof of payment of Administrative Fee” will be automatically generated for the applicant. The document has to be printed directly from the web browser. The document contains the variable symbol of the payment allocated to the application by the SÚKL identification system.

The applicant shall use the allocated variable symbol for the identification of the payment by bank transfer. The amount is stated in Czech Crowns. When making the payment it is necessary to inform the bank that the payment must be transferred to the SUKL account in the required currency and full amount and any costs of bank transfer/service charges shall be borne by the payer.

 

The requested activity cannot be carried out, if the payment does not show the allocated variable symbol! Pursuant to the Act on Administrative Fees, the applicant shall be sent an invitation to pay the fee within the timeline of 15 days. If the applicant fails to evidence the payment of the administrative fee (made with the allocated variable symbol) within the determined period, the administrative procedure will be suspended.

SÚKL details for bank transfers of administrative fee payments:

 

 

In exceptional cases, the administrative fee may be paid cash at the cash desk of the Institute or by revenue stamps (up to the amount of 5,000 CZK).

If the applicant does not have the opportunity to complete the interactive form, the document may be obtained from SÚKL mail room (Annex 2 refers).

 

1.2   Administrative fee refunds

Paid administrative fees may be refunded only for reasons stipulated by the Act on Administrative Fees (section 7).

If any of the statutory reasons for administrative fee refund arises, and the applicant files a request for refund, SÚKL shall decide about this request. The request should be filed using the “Request for Administrative Fee Refund” form (Annex 4).

 

Refunds of administrative fees paid by means of revenue stamps shall be made by SÚKL likewise (Section 7, paragraph 5 of the Act on Administrative Fees).

 

2           Reimbursements of costs of expert activities and annual maintenance fees

2.1          The procedure to be applied to the reimbursements of costs of activities conducted upon request and payments of annual maintenance fees

Pursuant to Section 112 of the Act on Pharmaceuticals, SÚKL collects reimbursements for expert activities conducted upon request and annual maintenance fees. This legal regulation allows SÚKL to collect the reimbursements in advance. The reimbursement of costs is payable before the submission of the application and shall be made by bank transfer, exceptionally cash at the cash desk, in the amount stipulated by the Pricelist (see Annex 1, part A).

The amount is stated in Czech Crowns. When making the payment it is necessary to inform the bank that the payment must be transferred to the SUKL account in the required currency and full amount and any costs of bank transfer/service charges shall be borne by the payer.

When paying the annual maintenance fee, the interactive form shall be used as for the reimbursement of costs. This payment is made without any submission of an application and proof of payment shall not be sent.  The Institute, having verified the accuracy of the payment, shall send a proof of payment of the annual maintenance fee to the payer.

 

SÚKL details for bank transfers for the reimbursement of costs for expert activities:

 

The document is generated automatically when the interactive form available from http://www.sukl.cz, section Pricelist and Fees is completed.

The applicant shall complete the required data in the interactive form. Once the form is posted, the “Proof of Payment of Costs for Expert Activities Conducted upon Request” is generated, which has to be printed directly from the internet browser. This document shows the generated variable symbol to be used for the payment of costs of expert activities associated with the application in question. For more detailed instructions please refer to the website mentioned above.

If the applicant does not have the opportunity to complete the interactive form, it is possible to obtain it from the SÚKL mail room (Annex 3).

   

Procedure to be applied in the payment of fees for variation to marketing authorisation within mutual recognition procedure

 Ad IA_IN: variation type that requires to be notified immediately (immediate notification – see application for variation to a marketing authorization)

 

Attachments to the application for an expert activity:  

• “Proof of Payment of Administrative Fee” form in two copies* (as per part 1 of the Guideline), if an administrative fee is associated with the procedure.  
• “Proof of Payment of Costs for Expert Activities Conducted upon Request” form in two copies* (as per part 2 of the Guideline).

* if submitted in hard copy.  

• Document evidencing that the costs have been reimbursed as per the Pricelist and a document evidencing that the administrative fee has been paid (where the Act stipulates that the reimbursement forms part of the particulars of the application) – where a non-cash transfer is concerned, this document shall be a copy of the payment order endorsed by the bank or a copy of the statement of account; if the reimbursement is paid cash at the cash desk, SÚKL cashier shall endorse the payment of costs directly in the “Proof of Payment of Costs for Expert Activities Conducted upon Request” form and the payment of the administrative fee directly in the “Proof of Payment of Administrative Fee” form.

2.2          Waivers and refunds of cost reimbursements

The procedure applicable to the situation when the Institute waives the reimbursement of costs or refunds parts thereof is provided in SÚKL guideline UST-24 - Waiver and refunds of reimbursement of costs for expert activities conducted upon request.  

 

3.     Reimbursement of costs for activities associated with the provision of information

With regard to the provision of information as stipulated by Section 17 of the Act on Free Access to information and by Section 4 of the Act on Libraries, SÚKL collects reimbursement of costs of activities associated with the provision of information.

The amounts of reimbursements of costs associated with the retrieval of information are provided in the Pricelist (Annex 1, part D). These activities are conducted on the basis of a binding written request signed by the applicant (an electronic request sent by e-mail to posta@suklcz shall be considered binding only if signed by a certified electronic signature, any other case shall be regarded a preliminary request which shall be binding and considered only after the delivery of a written signed request) specifying the required activity associated with the provision of information. SÚKL shall inform the applicant in writing about the calculation of the activity specifying the amount to be reimbursed prior to the provision of the information. This notice will clearly show the underlying facts for the calculation and the method how the amount has been calculated. Once the applicant confirms in writing the proposed calculation of the activity, incl. the amount of reimbursement, SÚKL shall issue an invoice with details necessary for the bank transfer (variable symbol, bank details for SÚKL). Costs may also be reimbursed by a cash payment made at the SÚKL cash desk.

 

SÚKL details for bank transfers for the reimbursement of costs for activities associated with the provision of information:

 

Name of the bank	Česká národní banka
Address of the bank	Na Příkopě 28/3181 Praha 1 115 03 Czech Republic
Account number	35-623101
Bank code	0710
IBAN	CZ94 0710 0000 3500 0062 3101
BIC (originally SWIFT)	CNBACZPP
Constant symbol	0308
Variable symbol	by invoice

 

4.    Reimbursement of other activities

Pursuant to Section 6 of the Act on Budgetary rules, SÚKL shall collect reimbursement of costs associated with the rent of the property of the Czech Republic which it administers.

The amounts of reimbursements of these costs are provided in the Pricelist (Annex 1, part E). The services shall be provided on the basis of a binding written request signed by the applicant (an electronic request sent by e-mail to posta@suklcz shall be considered binding only if signed by a certified electronic signature, any other case shall be regarded a preliminary request which shall be binding and considered only after the delivery of a written signed request) specifying the required service. After the service is provided, SÚKL shall issue an invoice and send it to the applicant; the invoice shall show data necessary for the bank transfer (variable symbol, bank details for SÚKL). Costs may also be reimbursed by a cash payment made at the cash desk.

 

SÚKL details for bank transfers for the reimbursement of costs for other activities:

 

Name of the bank	Česká národní banka
Address of the bank	Na Příkopě 28/3181 Praha 1 115 03 Czech Republic
Account number	19-623101
Bank code	0710
IBAN	CZ19 0710 0000 1900 0062 3101
BIC (originally SWIFT)	CNBACZPP
Constant symbol	0308
Variable symbol	by invoice

 

• UST-29 version 9_Application for administrative fee refund, soubor typu doc, (41 kB)
• UST-29 version 9_Pricelist of cost reimbursements, soubor typu doc, (509 kB)
• UST-29 version 9_Substitute form for obtaining details associated with the payment of an administrative fee, soubor typu doc, (59.5 kB)
• UST-29_version_9_Substitute form for obtaining details associated with the reimbursement of costs for expert activities conducted upon request, soubor typu doc, (75.5 kB)