Article 13. State Registration of Medicinal Products

1. Medicinal products are put into civil circulation in the Russian Federation provided they have been registered with the relevant authorized federal executive body.

2. State registration is required for:

1) originator medicinal products;
2) generic medicinal products;
3) new combinations of previously registered medicinal products;
4) new dosage forms or new dosage rates of previously registered medicinal products.

3. State registration of medicinal products for medical use shall be carried out based on the results of expert examination of the medicines and ethical expert examination of the possibility of a clinical trial of the medicinal product for medical use (hereinafter – the “ethical expert examination”). State registration of medicinal products for veterinary use is carried out based on the results of expert examination of the medicines for veterinary use.

4. State registration of medicinal products shall be carried out by the relevant authorized federal executive body within the period not exceeding two hundred and ten business days upon filing an application for state registration of the medicinal product. The period specified above includes the time necessary to carry out repeated expert examination of the medicines and (or) repeated ethical expert examination in accordance with Article 25 hereof. The period of state registration of a medicinal product is calculated from the date of filing by the relevant authorized federal executive body of an application for state registration of the medicinal product together with required documents as enclosed to the date of issuance of the registration certificate for the medicinal product. The time spent on a clinical trial of the medicinal product is not considered when calculating the period of state registration.

5. No state registration is required for:

1) medicinal products compounded by pharmacy institutions, veterinary pharmacy institutions and individual entrepreneurs holding pharmaceutical licenses under medicinal product prescriptions and orders of medical institutions and veterinary institutions;
2) herbal medicinal raw materials;
3) medicinal products acquired by individuals outside the Russian Federation and intended for personal use;
4) medicinal products intended for export;
5) radiopharmaceutical medicinal products compounded directly in medical institutions in the manner prescribed by the authorized federal executive body.

6. State registration is forbidden for:

1) different medicinal products under the same trade name;
2) one and the same medicinal product manufactured by the manufacturer under different trade names and submitted for state registration as two or more medicinal products.