Article 24.  Expert Examination of Quality of a Medicine and Expert Examination of Correlation between Anticipated Benefit and Possible Risk from Use of Medicinal Product for Veterinary 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 veterinary use, generation of conclusions based on the results of expert examinations by expert councils 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, 10, Items a-e, g-l and o-t of Sub-clause 16 and Sub-clause17 of Clause 3 of Article 18 hereof.

2. Within fifteen business days from the date of receipt of the decision on performance of the expert examinations specified in Clause 1 of this article issued by the authorized federal executive body, the applicant shall submit samples of the medicinal product for veterinary use manufactured in compliance with the requirements of the technological regulations approved by the head of the medicines manufacturing company, as well as sample of the pharmaceutical substance in the quantities necessary to reproduce the quality control methods, for the purpose of expert examination of the quality of the medicinal product.

3. On receipt of samples of the 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.

4. The period of submission of samples of the 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 2 and 3 of this article are not included in the period of performance of expert examinations specified in Clause 1 of this article.

5. 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.