I don't understand the documentation request, I'm not sure what to submit. What should I do?
In case of any doubts, always ask as soon as possible. If it is not possible to provide the requested information (or not within the required timeframe), it is recommended to inform the inspectors as early as possible. If there is a planned change in written procedures during the inspection, submit the current valid procedures and at the same time inform SÚKL about the upcoming changes.