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Important information
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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).
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6. 5. 2025
Information on adverse drug reaction reporting in SmPC and PL
The State Institute for Drug Control (SÚKL) informs the marketing authorization holders on how to include the information on adverse drug reaction (ADR) reporting in the Product Information (section…
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6. 5. 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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