Instructions for payment of expenses and administrative charges
The conditions and payment process for the reimbursement of costs for expert activities conducted upon request (Section 112 of Act No 378/2007 Coll., on Pharmaceuticals, as amended, and Section 27 of Act No 296/2008 Coll., on Safeguarding the Quality and Safety of Human Tissues and Cells Intended for Use in Man and on Amendments to Related Acts, and Section 94 of Act No 268/2014 Coll., on Medical Devices and on Amendments to Act No 634/2004 Coll., on Administrative Fees, as Amended) are stipulated in SÚKL guidelines UST-29 and UST-36. The currently effective versions of guidelines UST-29 and UST-36 specify the conditions and procedures applicable to the payment process for the reimbursement of costs for expert activities conducted upon request.
- In compliance withSection 112 of Act No 378/2007Coll., on Pharmaceuticals and on Amendments to Some Related Acts, as amended;
- In compliance withSection 27 of Act No 296/2008 Coll., on Safeguarding the Quality and Safety of Human Tissues and Cells Intended for Use in Man and on Amendments to Related Acts, the conditions and procedures applicable to reimbursement are specified in SÚKL guidelines UST-29 and UST-36. The pricelists of costs reimbursementsare annexed to these guidelines;
- In compliance with Section 94 of Act No 268/2014 Coll., on Medical Devices and on Amendments to Act No 634/2004 Coll., on Administrative Fees, As Amended.
The payments covering the costs incurred are to be made by bank transfer prior to the submission of the application. The variable symbol for the payment to be made can be obtained from the interactive form available from SÚKL’s website. Please note: while this form is being completed, the entered account number, which must be in the IBAN format, is being checked for correctness. For details concerning the completion of this form please refer to guidelines UST-29 and UST-36.
Following the completion and posting of the form, the data you have entered will be recorded in the database and the “Payment order covering expenditures for expert activities conducted upon request” will be displayed showing the variable symbol under which you will pay the payment. This Payment order has to be submitted together with the application. Once the payment is credited to the relevant account, we will issue the Proof of payment covering expenditures that will serve as your accounting proof of payment covering expenditures.
Please note: if you submit incorrect data in the form and identify the error only subsequently, please complete the form again using correct data and generate the new Payment order. SÚKL processes only data on forms submitted to SÚKL, e.g. together with an application. If the application with incorrectly generated Payment order has already been submitted to SÚKL, it is necessary to inform SÚKL to this fact and apply for deletion of the original form from the database and for refund of the payment made (based on the completed application). The application can be found on the SUKL website (UST-24, Annex 1 or Annex 2).
The payments set in the guidance documents UST-29 and UST-36 should be made 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.
If the payment is not made under the correct variable symbol, it is possible to ask the SÚKL accounting unit for a transfer from the original VS to the new VS. If the payment is made collectively for several variable symbols, it will be considered as an incorrect payment and shall be either refunded as a whole, or – where collective payments are concerned – partly assigned with the correct variable symbol and the rest refunded as overpayment.
Should you encounter any problems while completing or printing the form, please contact us at: infs@sukl.gov.cz. We will be happy to help you.
With regard to the provision of Act No 634/2004 Coll., on Administrative fees, as amended, an applicant is obliged to pay administrative fees for the submission of an application.
The amounts of administrative fees are specified in the Annex to the above mentioned Act, and for better orientation, services subjected to fees within the scope of administrative procedures performed by the State Institute for Drug Control and the amounts of the respective administrative fees are listed in guidelines UST-29 and UST-36. More details regarding administrative fees are also provided in the said guidelines.
Applicants are advised to pay the administrative fees by bank transfer prior to the submission of the application. The variable symbol for the payment to be made can be obtained from the interactive form. For details concerning the completion of this form please refer to guidelines UST-29 and UST-36.
Following the completion and posting of the form, the data you have entered will be recorded in the database and you will be presented with the Administrative Fee Payment Confirmation screen which will give the variable symbol for you to use when making the payment. This payment receipt is to be presented in two copies together with the application (If application submitted in hard-copy). Once the payment is credited to the relevant account, we will endorse this fact using the Administrative Fee Payment Receipt. We will send this receipt back to you. The document endorsed as mentioned above will serve as your accounting proof of payment of the administrative fee.
Administrative fees may be also paid using a revenue stamp (up to 5 thous. CZK) affixed to the free space in the upper left part of the form (UST-29). The form is identical to the one for the payment of the administrative fee via bank transfer.
The State Institute for Drug Control may, in cases referred to in the Act, waive the full amount of reimbursed costs or part of it. In justified cases it may also refund the reimbursed costs.
Waiving the reimbursement of costs
The State Institute for Drug Control (hereinafter referred to as the “Institute”) shall, pursuant to no other reasons than stated in Section 112, paragraph 3, letter (b) of Act No 378/2007 Coll., on Pharmaceuticals, as last amended (hereinafter referred to as the “Act on Pharmaceuticals”) and pursuant to Section 27, paragraph 3, letter b) of Act No 296/2008 Coll. , on Safeguarding the Quality and Safety of Human Tissues and Cells Intended for Use in Man and on Amendments to Related Acts (Act on Human Tissues and Cells), fully or partly waive the reimbursement of costs if associated with activities:
- performed in relation to adoption of marketing authorisation or
- whose conduct is in the public interest or
- which may have particularly significant implications for a wide scope of persons.
The Institute shall consider waiving of the reimbursement of costs only if requested to do so.
Refunds of reimbursed costs based on a request
The Institute shall fully or partially refund the reimbursed costs to the applicant in the following cases:
a) If the applicant has reimbursed the costs without being obliged to do so, the Institute shall refund the full amount;
b) If the procedure or the requested activity have not commenced at all, the Institute shall refund the full amount;
c) If the applicant has paid a higher amount than established in SUKL Pricelist (guideline UST-29, UST-36), the Institute shall refund the difference between the two amounts;
d) If the applicant has paid and consequently upon his request the Institute has waived the reimbursement of costs, the Institute shall refund the full amount,
e) If an administrative procedure is suspended upon the applicant’s request or if an expert activity carried out outside the scope of an administrative procedure is terminated upon the applicant’s request, the Institute shall refund an amount of the reimbursed costs which is proportionate to the expert activities which have not yet been conducted at the time of termination the processing of the application; if an assessment report has been prepared, all expert activities shall be rendered completed;
The Institute shall refund the reimbursed costs on the basis of a signed application.
For more details regarding the waivers and refunds of cost reimbursement please refer to SÚKL guideline UST-24.
Pursuant to Section 112, paragraph 3 (b) of Act No 378/2007 Coll., on Pharmaceuticals, as amended, the Institute shall, upon request, waive the full amount of reimbursement of costs or part of it, where take-over of a marketing authorisation or acts conducted in public interest or those which may be of special relevance to a wider group of people, are concerned, and which involve, in particular, the following:
- orphan human medicinal products;
- medicinal products intended for use solely in persons under the age of 18 years;
- acts conducted upon request of entities to which support referred to in a directly applicable Community regulation, e.g. Regulation no. 726/2004 (EC) of the European Parliament and of the Council, applies.
Pursuant to Section 3, letter b) Decree No 427/2008 Coll., on reimbursement of expert activities conducted by the State Institute for Drug Control and the Institute for the State Control of Veterinary Biologicals and Medicaments, the applicant shall reimburse as much as 50% of the amount of costs established by the Pricelist for the requested expert activity conducted on the basis of an application where the applicant meets the conditions for the classification as a micro, small or medium-sized enterprise referred to in Section 5, paragraph 2 and has not been contracted or otherwise engaged by any other entity which does not meet the criteria of a micro, small or medium company, to conduct an activity associated with the requested activity, hereto in compliance with a directly applicable regulation of the European Communities
Pursuant to Section 5, article 2. Decree No 427/2008 Coll., on reimbursement of expert activities conducted by the State Institute for Drug Control and the Institute for the State Control of Veterinary Biologicals and Medicaments, for the purposes of this decree, a micro, small and medium-sized enterprise shall mean an enterprise meeting the conditions stipulated by other legal regulations.
Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (Text with EEA relevance)