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Important information
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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).
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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…
