Waivers and refunds of reimbursements of costs for expert activities conducted upon request

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.