SÚKL has added a new folder in the clinical trial section called „REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL“ on his website, where it is possible to find all articles related to the regulation and the EU portal.
Also there will be updated all current information related to CTIS (Clinical Trials Information System). It also publishes requirements for the labeling of such products in the English version.
For more information click here.
