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13. 11. 2025
The document Recommendation Paper on Frequent Issues Identified during…
This paper summarises the most common comments and observations raised by Member States and Ethics Committees during the assessment of clinical trial applications. It also provides recommendations…
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9. 7. 2025
Zero Day Procedure: Request for New Marketing Authorisation in the Czech…
The Marketing Authorisation Section of the State Institute for Drug Control (SÚKL) informs about the authorisation of medicinal products through the mutual recognition procedure with an accelerated…
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6. 6. 2025
Information about the change in SÚKL practice of a DCP slots allocation
SÚKL informs about the planned changes in the system of allocation of slots for decentralised procedures (DCP) with SÚKL as a reference member state (RMS).
