Important information
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18. 12. 2025
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…
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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…