Article 23. Expert Examination of Quality of a Medicine and Expert Examination of Correlation between Anticipated Benefit and Possible Risk from Use of Medicinal Product for Medical use

1. Expert examination of the quality of a medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of a medicinal product for medical use, generation of conclusions by the expert councils based on the results of clinical trials and forwarding of such conclusions to the authorized federal executive body shall be exercised within the period not exceeding one hundred and ten business days from the date of receipt by the expert institution of the relevant assignment issued by the authorized federal executive body together with the documents specified in Sub-clauses 1 – 8 and 15 - 17 of Clause 3 of Article 18 hereof and a report on the clinical trial of the medicinal product for medical use conducted.

2. For the purpose of expert examinations specified in Clause 1 of this article, the applicant shall submit to the authorized federal executive body:

1) application for renewal of state registration of the medicinal product and performance of the expert examinations specified in Clause 1 of this article;
2) report on the clinical trial of the medicinal product for medical use conducted;
3) document certifying payment of the state duty for performance of expert examination of the quality of the medicine and expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product for medical use when applying for state registration.

3. Within the period not exceeding five business days from the date of receipt of the application together with the documents specified in Clause 1 and Sub-clauses 2 and 3 of Clause 2 of this article, the authorized body shall:

1) examine the data contained in the report on clinical trial of the medicinal product for medical use submitted by the applicant for completeness and reliability;
2) take decision on renewal of state registration of the medicinal product and performance of the expert examinations specified in Clause 1 of this article, or on refusal to renew state registration of the medicinal product and carry out such expert examinations;
3) notify the applicant in writing of the positive decision or, in case of refusal, of the grounds for such refusal.

4. Failure to submit a complete set of the documents listed in Clause 1 and Sub-clauses 2 and 3 of Clause 2 of this article, or submission of the report on the clinical trial of the medicinal product for medical use lacking a comprehensive list of necessary information is considered grounds for refusal to renew state registration and carry out expert examinations specified in Clause 1 of this article.

5. Within fifteen business days from the date of receipt of the decision on renewal of state registration of the medicinal product and performance of expert examinations specified in Clause 1 of this article, issued by the authorized federal executive body, the applicant shall submit samples of the medicine product for medical use manufactured in compliance with the requirements of the experimental industrial regulations and (or) industrial regulations approved by the head of the medicines manufacturing company, as well as, in appropriate cases, sample of the pharmaceutical substance, test strain of microorganisms, cultured cells, samples of substances used for quality control of a medicinal product be means of comparison of a medicinal drug to them, in the quantities necessary to reproduce the quality control methods, for the purpose of expert examination of the quality of the medicinal product.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

6. On receipt of samples of a medicinal product and pharmaceutical substance the expert institution shall provide the applicant with a document certifying the receipt of such samples, and notify the authorized executive body thereof in writing within the period not exceeding three business days.

7. The period of submission of samples of a medicinal product and pharmaceutical substance by the applicant and the period of a written notification thereof of the authorized federal executive body by the expert institution specified in Clauses 5 and 6 of this article are not included in the period of performance of expert examinations specified in Clause 1 of this article.

8. The documents submitted to the expert institution for performance of expert examinations specified in Clause 1 of this article are subject to return to the authorized federal executive body concurrently with the conclusions based on the results of such expert examinations.