Amendment to the Reimbursement Decree effective as of January 1, 2026
On January 1, 2026, amendment to Decree No 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the Institute for State Control of Veterinary Biologicals and Medicines, amending reimbursements of costs in the sphere of payments relevant for the State Institute for Drug Control including payments for marketing authorisation of medicinal products and annual maintnance payments, becomes effective.
Payment of reimbursement of costs associated with applications submitted until December 31, 2025
For applications submitted until December 31, 2025 (incl.), the amounts of reimbursement of costs set forth by Decree No 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the Institute for State Control of Veterinary Biologicals and Medicines (hereinafter referred to as the Reimbursement Decree”) before the aforementioned amendment shall be applicable.
Payment of reimbursement of costs associated with applications submitted from January 1, 2026
For applications submitted from January 1, 2026 (incl.), the new amounts of reimbursement of costs set forth by the amendment to the Reimbursement Decree shall apply (link: The Amendment to the Reimbursement Decree No. 501/2025 Coll.)
Annual maintenance payments
Annual maintenance payments for the year 2026 are subject to payments from the pre-amendment reimbursement decree (even in cases where the payment is made only after the request, i.e., after January 1, 2026). The new amounts from the amended reimbursement decree apply only to maintenance payments for 2027.
Reimbursement payment form
For selecting the amount before/after the amendment of the reimbursement decree, in the next few days a toggle will be added to the specific expense reimbursement forms, allowing you to choose whether you are generating a payment for an application submitted before or after January 1, 2026. The correct relevant amount will be generated based on the selection.
For annual maintenance payments, the toggle is not yet relevant because payments are currently being generated for 2026, which are subject only to the pre-amendment compensation decree.
Administrative fees
The amendment to the reimbursement decree only regulates the amount of reimbursement of expenses. The amount of administrative fees is therefore unchanged.