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Important information

  • 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…

  • 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…

  • 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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