Article 27. Decision on State Registration of a Medicinal Product

1. Within the period not exceeding five business days from the date of receipt of the conclusions issued by the expert commission based on the results of 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 the medicinal product the relative authorized federal executive body shall:

1) evaluate such conclusions in order to determine compliance thereof with the assignment for performance of such expert examinations;
2) take a decision on whether to approve state registration of the medicinal product or to refuse approving state registration of the medicinal product;
3) in case of a positive decision on state registration of the medicinal product, enter the data on the registered medicinal product, including, but not limited to the data on the pharmaceutical substance contained in the medicinal product, into the state register of medicines and issue to the applicant a registration certificate, the form of which is to be approved by the authorized federal executive body, approved normative documentation, the normative document, Package Leaflet for the medicinal product and designs of the primary and secondary (retail) packages bearing the number of the registration certificate for the medicinal product and the date of state registration thereof or, in case of refusal of state registration of the medicinal product, notify the applicant in writing of the grounds for such refusal;

2. Decision of the relevant authorized federal executive body stating that the data obtained do not confirm quality and(or) efficacy of the medicinal product to be registered, or possible health hazard to human beings and animals taking the medical product exceeds the efficacy thereof is considered grounds for refusal of state registration of the medicinal product.
(as amended by Federal Law of October 11, 2010, No. 271-FZ)

3. When registering a medicinal product included in the list of vital and essential medicinal products, necessary data shall be entered into the state register of maximum ex-works manufacturers’ prices for the medicinal products included in such list.