Drug database
Christmas break for VHP procedures (2018)
SÚKL informs about a Christmas break for VHP procedures (Clinical Trial Applications submitted via VHP procedure). This break does not aplly to national submissions of Clinical Trial Applications.
For this year a Christmas break for VHP procedures will start from 21st December 2018 and will end on the 7th January 2019. This means that the procedures will be frozen at the respective step/date on 21st December 2018 and resumed on 7th January 2019. Practically this means for example that if day 8 of the 10 days to respond to GNA (Grounds for Non-Acceptance) is on 21st December 2018 then day 9 of the 10 will be on the 7th January 2019. This approach is applied to all other steps of the VHP and VHP-SA too.
Clinical Trials Department
7th December 2018