Article 22. Decision on Conducting of Clinical Trial of Medicinal Product for Medical use

1. To obtain a permit to conduct a clinical trial of a medicinal product for medical use, the applicant shall submit to the authorized federal executive body:

1) application for issuance of a permit to conduct such clinical trial;
2) information on the researchers’ experience in the relevant fields and in conducting clinical trials;
3) the copy of contract of compulsory insurance of the life and health of a patient involved in clinical trials of medicinal products for medical use (hereinafter “the contract of compulsory insurance”), made in accordance to the standard rules for compulsory life and health insurance of a patient involved in clinical trials of medicinal products for medical use approved by the Government of the Russian Federation (hereinafter “the standard rules for compulsory insurance”), with specifying the maximal number of patients involved in clinical trial of medicinal products for medical use ;
(as amended by Federal Law of November 29, 2010, No. 313-FZ)
4) the details of medical organizations which are scheduled to conduct clinical trials of  medicinal product for medical use (full and brief names of medical institution, legal form of medical institution, the seat and business location of medical institution, telephone, telefax, email address);
(as amended by Federal Law of November 29, 2010, No. 313-FZ)
5) estimated terms of the clinical trial of the medicinal product for medical use.
(sub-clause 5 introduced by Federal Law of October 11, 2010, No. 271-FZ)

2. Within the period not exceeding five business days from the date of receipt of the application specified in Clause 1 of this article together with necessary documents, the authorized federal executive body shall:

1) examine the data contained in the materials submitted by the applicant for completeness and reliability;
2) take decision on issuance of a permit to conduct the clinical trial of the medicinal product for medical use, or on refusal to issue such permit;
3) notify the applicant in writing of the positive decision or, in case of refusal, of the grounds for such refusal;
4) issue a permit to conduct the clinical trial of the medicinal product for medical use in the manner prescribed by the authorized federal executive body.

3. Failure to submit the documents specified in Clause 1 of this article, or non-compliance of the documents submitted with the requirements of this Federal Law, or the presence of the conclusion issued by the expert institution or the conclusion issued by the Ethical council on impossibility of conducting of clinical trial of a medicinal product for medical use on the base of results of performed expert examinations provided for in Article 20 of this Federal law is considered grounds for refusal to issue a permit to conduct the clinical trial of the medicinal product.
(as amended by Federal Law of October 11, 2010, No. 271-FZ)