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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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14. 8. 2025
SÚKL Notice on Updated Guidance for Adverse Drug Reaction Reporting Listed…
SÚKL notification regarding the updated information on adverse drug reaction reporting in SmPC and PL due to the change of the SÚKL web address (introduction of the “sukl.gov.cz” domain) and…
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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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