Following our existing experience with reviews of applications for approval of clinical trials on the above mentioned investigational medicinal products and the compexity thereof, the applicants are kindly requested to inform the Institute of the planned submissions in advance (by e-mail:
alice.nemcova@sukl![_](/modules/marwel/images/tecka.gif)
Please note that the medicinal products of the nature mentioned above are reviewed within a 90-day period, which can be, when appropriately justified, extended by additional 90 days. No timelines are set for the review of medicinal products of xenogeneic origin.
Although there are no legal grounds for this guidance, we would highly appreciate if this approach could be put into practice, helping us organise our work more effectively. Thank you for you co-operation.