Annual maintenance fee

SÚKL informs marketing authorisation holders of their obligation to pay reimbursement of expenses for activities performed by SÚKL in connection with the maintenance of marketing authorisations for medicinal products in the form of annual maintenance fees.

Notice

The State Institute for Drug Control (SÚKL) would like to inform marketing authorisation holders that the annual maintenance fee rates for 2027 have been amended following the entry into force of Decree No. 427/2008 Coll., as amended (the reimbursement of expenses decree).

As a consequence of this amendment, the online form used for generating a variable payment reference number has been updated with a selector allowing users to choose the applicable fee schedule version, similarly to other types of expense reimbursements:

• The default pre-selected option “Payments applicable as of 1 January 2026” corresponds to the currently applicable legislation (i.e. the rates applicable to payments generated for 2027 and further).
• The alternative option “Previous payments” is intended exclusively for the subsequent generation of payments that should have been made for 2026 or earlier years.

Legal Basis and Due Date

Pursuant to Section 112(2) of Act No. 378/2007 Coll., on Pharmaceuticals, as amended (hereinafter referred to as the “Act on Pharmaceuticals”), marketing authorisation holders are required to reimburse the expenses incurred by SÚKL in connection with activities related to the maintenance of marketing authorisations for medicinal products.

• The annual maintenance fee for the following calendar year must be paid no later than 31 December of the preceding year and becomes due on 1 January of the relevant year.
• No fee is payable for the year in which the marketing authorisation is granted.

Reimbursement Amounts

The reimbursement amounts are laid down in Decree No. 427/2008 Coll., as amended.

The annual maintenance fee is not applicable:

• for centrally authorised medicinal products;
• for the year in which the marketing authorisation is granted.

Procedure in Case of Late Payment

If the fee is not paid within the prescribed time limit:

1. SÚKL will send a notice (by post or via data box) to the marketing authorisation holder requesting payment within 15 days of receipt of the notice.
2. If payment is not made within this additional period, the amount due will be increased by 50% (instructions for making such payment are provided in the section Instructions for Completing the Form below).
3. If the marketing authorisation holder fails to pay the increased amount without undue delay, the outstanding amount will be recovered in accordance with the applicable legal provisions.

Payment Method

• The fee must be paid separately for each medicinal product, identified by its marketing authorisation number.
• A separate variable payment reference number must be generated for each marketing authorisation number and calendar year using the online form (instructions provided below).
• Bulk payments cannot be accepted, i.e. a single payment covering several medicinal products, because without a unique variable payment reference number for each marketing authorisation number, the payment cannot be assigned to a specific medicinal product.
• Fees are set in Czech crowns (CZK). Any bank charges shall be borne by the payer (further information is available in guideline UST-29).

The online form for generating the variable payment reference number is available on the SÚKL website.

Instructions for Completing the Payment Form

• Select reimbursement code U-001 to U-005 according to the type of authorisation applicable to the medicinal product concerned. Multiple marketing authorisation numbers may be entered in a single form only if the same reimbursement code applies to all of them.
• After selecting the relevant code, it is possible to tick the “Late Payment” field, which automatically calculates the amount increased by 50%. This option should only be selected if you have received a payment notice from SÚKL requesting payment of the maintenance fee and the 15-day payment period specified in the notice has already expired.
• The marketing authorisation number must be entered correctly in the format, for example, AA/BBBB/XX-C or AA/BBBB/XX-S/C, while preserving the exact sequence of characters, slashes and hyphens. This is necessary to ensure automatic matching of the maintenance fee payment with the relevant marketing authorisation number.
• Upon submission of the form, a confirmation together with the generated variable payment reference number will be sent to the contact e-mail address provided. If one form is submitted for multiple marketing authorisation numbers, a separate variable payment reference number will be generated for each number.
• It is no longer necessary to submit the form entitled “Confirmation of Payment of Reimbursement of Expenses” to SÚKL. If the marketing authorisation number has been entered correctly, the medicinal product and the variable payment reference number will be matched automatically.
• Once payment has been verified, SÚKL will issue a “Confirmation of Payment of the Annual Maintenance Fee” to the payer.

Payment Details

Marketing Authorisation Section
update 6. 8. 2026