The State Institute for Drug Control (hereinafter the “Institute”) informs about current service outages of Verso and DSŘ (documents of CAU administrative proceedings). The reason for these outages is unforeseen technical issues on the side of an external supplier. Intensive work is underway to resolve the problem with the aim of restoring full system functionality as soon as possible. System adjustments have been implemented to eliminate the causes of the issues, along with improved monitoring and control of errors arising from this situation.
At this time, we can confirm that access to case files via the Verso application when logged in using the National Identification and Authentication Point (NIA), i.e. the so-called citizen identity, is functioning without limitations. Unfortunately, complications persist with access without login, which we are actively addressing.
We therefore recommend using login via citizen identity when accessing Verso.
Recommended Procedures for Affected Parties to Administrative Proceedings
In-person access to the case file Access to the case file pursuant to Section 38 of Act No. 500/2004 Coll., the Administrative Procedure Code, remains available at the Institute’s premises. When: Working days, 8:00–16:00 Where: SÚKL headquarters – Building B (Benešovská 2538/40, 101 00 Prague 10) Contact for appointment booking: cau_sekretariat@sukl.gov.cz
Monitoring the Official Notice Board Due to the technical outage, participants in administrative proceedings are advised to pay increased attention to monitoring the Institute’sOfficial Notice Board. Documents published by way of public notice in proceedings under Part Six of Act No. 48/1997 Coll., on Public Health Insurance, may be posted there and may include deadlines for procedural actions.
Procedural Deadlines and Applications If a technical obstacle on the part of the Institute objectively prevents a party from performing a procedural act within the prescribed time limit, the following instruments under the Administrative Procedure Code may be used: Extension of a deadline / suspension of proceedings: This may be requested if there is a risk of missing a deadline due to the unavailability of remote access. The request must be submitted sufficiently in advance. Waiver of missed deadline: If a deadline has already expired, the party may request a waiver pursuant to Section 41(2) of the Administrative Procedure Code. Each such request will be assessed individually, taking into account the current technical situation.
Note: Information on the restoration of the Verso system will be published on this page without delay. We apologise for the inconvenience caused and thank you for your understanding.
FAQ
1) Is it currently possible to access a case file?
Yes, in person at the Institute’s premises, Monday–Friday, 8:00–16:00. The Verso service may be temporarily unavailable.
2) What is DSŘ and can it be used instead of case file access?
DSŘ is an automated method for downloading selected documents (system-to-system communication). It is not an alternative to access to the case file under Section 38 of the Administrative Procedure Code and cannot replace it. DSŘ availability may be limited.
3) I am unable to meet a deadline due to the outage — what should I do?
Submit a timely request for an extension of the deadline or suspension of proceedings; after the deadline has expired, you may request a waiver pursuant to Section 41(2) of the Administrative Procedure Code.
4) How should I proceed if I need a specific document?
Book an in-person file inspection; for general orientation in the proceedings, continuously monitor the Official Notice Board.
The text of this article was taken in full from the SÚKL website.
SÚKL warns of possible limitations affecting remote access to case files via the Verso application and automated access to documents of administrative proceedings in CAU (DSŘ).
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
