Important information
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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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11. 11. 2024
New application for reporting the marketing of medicinal products
SÚKL has created a new application for reporting the launch, interruption, renewal or termination of marketing.
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1. 11. 2024
Unavailability of Market Report and launch of new application
Outage of the drug shortage reporting system from Thursday 7 November 2024 to Monday 11 November 2024 in connection with the upgrade to the new application.