Article 29. Confirmation of State Registration of a Medicinal Product

1. Confirmation of state registration of a medicinal product shall be carried out when issuing a permanent registration certificate for the medicinal product in the case specified in Clause 2 of Article 28 hereof, within the period not exceeding ninety business days from the date of receipt of an application for confirmation of state registration of the medicinal product executed in accordance with Clause 2 of Article 18 hereof.

2. Confirmation of state registration of a medicinal product is carried out based on the results of expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product as well as expert examination of the quality of the medicine, carried out in the case of amendments to normative documentation or normative document.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

3. The document certifying payment of the state duty for confirmation of state registration of the medicinal product for medical use or the medicinal product for veterinary use, and the document containing the results of safety monitoring of the medicinal product conducted by the applicant, executed as prescribed by the relevant authorized federal executive body, shall be enclosed with the application for confirmation of state registration of the medicinal product. Normative documentation or normative document, draft instructions for use of the medicinal product, draft designs of primary packages and secondary (retail) packages for the medicinal product shall be enclosed with the application for confirmation of state registration of the medicinal product again only in the case of amendments to them.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

4. Within ten business days upon the date of receipt of an application for confirmation of state registration of a medicinal product and necessary documents, the relevant authorized federal executive body shall:

1) examine the data contained in the materials submitted by the applicant for completeness and reliability;
2) make a decision on whether to carry out or refuse carrying out expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product as well as expert examination of the quality of the medicine, carried out in the case of amendments to normative documentation or normative document;
(as amended by Federal Law of November 29, 2010, No. 313-FZ)
3) notify the applicant in writing of the positive decision or, in case of refusal to carry out expert examination, of the grounds for such refusal.

5. Failure to submit a complete set of the documents listed in Clauses 1 and 3 of this article, or submission of the documents lacking comprehensive information which shall be reflected therein is considered grounds for refusal to carry out expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product and (or) expert examination of the quality of the medicinal drug.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

6. Expert examination of the quality of the medicine and (or) expert examination of a correlation between the anticipated benefit and possible risk from the use of the medicinal product for the purpose of confirmation of state registration of a medicinal product shall be carried out based on the documents specified in Clause 3 of this Article, in the manner prescribed in Clauses 5 - 8 of Articles 23 and 24 hereof.
(as amended by Federal Law of November 29, 2010, No. 313-FZ)

7. While the procedure of confirmation of state registration of a medicinal product is on, civil circulation thereof is conducted within the territory of the Russian Federation.