Scientific Advice provided by the Marketing Authorization branch

The Marketing Authorization branch of the State Institute for Drug Control (hereinafter the “Institute”) provides Scientific Advice upon request concerning procedural-regulatory issues and scientific requirements related in particular to applications for marketing authorization, variation applications and marketing authorisation renewal applications. Scientific Advice is a paid service of the Institute and is provided only outside the ongoing administrative proceedings (e.g. before submission of a marketing authorization application in the phase of “medicinal product development”, before submission of a marketing authorisation variation or renewal application).