Article 20. Expert Examination of Documents Necessary to Obtain Permit for Conduct of Clinical Trial of Medicinal Product for Medical use and Ethical Expert Examination

1. Expert examination of documents necessary to obtain a permit to conduct a clinical trial of a medicinal product for medical use in accordance with the objectives specified in Article 38 hereof, ethical expert examination, generation of conclusions on possibility or non-possibility of the conduct of such clinical trial by the expert council and ethical council, and forwarding of such conclusions to the authorized federal executive body shall be exercised within the period not exceeding thirty business days from the date of receipt by the expert institution of the assignment issued by the authorized federal executive body together with necessary documents specified in Sub-clauses 9, 11, 12 of Clause 3 of Article 18 hereof, and documents specified in Clause 4 of Article 18 hereof as submitted at the request of the applicant, and from the date of receipt by the expert council of the assignment issued by the authorized federal executive body together with necessary documents specified in Sub-clauses 11 – 14 of Clause 3 of Article 18 hereof.

2. The documents contained in the registration dossier and submitted to the expert institution and expert council for performance of expert examination thereof for the purpose of obtaining a permit to conduct a clinical trial of the medicinal product for medical use are subject to return to the authorized federal executive body concurrently with the relevant expert examination conclusions.