Article 21. Procedure for Obtaining Permit to Conduct Clinical Trial of Medicinal Product for Medical use

1. Within the period not exceeding five business days from the date of receipt of the conclusions specified in Article 20 hereof, the authorized federal executive body shall evaluate the conclusions received to determine their compliance with the assignments for performance of the relevant expert examinations, and notify the applicant in writing of the results of the expert examinations which have been carried out and of the possibility or non-possibility of issuance of a permit to the applicant with respect to conduct a clinical trial of the medicinal product for medical use.

2. In case of a positive decision on the possibility of issuance of a permit to conduct a clinical trial of the medicinal product for medical use, the authorized federal executive body suspends performance of state registration of the medicinal product until the applicant has applied for a permit to conduct a clinical trial of the medicinal product for medical use to the authorized federal executive body.

3. In case of a negative decision on the possibility of issuance of a permit to conduct a clinical trial of the medicinal product for medical use, the authorized federal executive body stops the procedure of state registration of the medicinal product.