Rospotrebnadzor Licences

1. Activities involving the use of ionizing radiation sources (generating sources) — except where used in medical activities. The list of work under the appendix to Government Resolution No. 45 comprises 10 items:

1. Design of ionizing radiation sources (generating sources).
2. Engineering of ionizing radiation sources (generating sources).
3. Manufacture of ionizing radiation sources (generating sources).
4. Placement of ionizing radiation sources (generating sources).
5. Operation of ionizing radiation sources (generating sources).
6. Maintenance of ionizing radiation sources (generating sources).
7. Storage of ionizing radiation sources (generating sources).
8. Design of radiation-protection equipment for ionizing radiation sources (generating sources).
9. Engineering of radiation-protection equipment for ionizing radiation sources (generating sources).
10. Manufacture of radiation-protection equipment for ionizing radiation sources (generating sources).

2. Activities involving human and animal infectious disease agents (except for medical purposes) and genetically modified organisms of potential hazard Classes III and IV (in contained systems).

Use of ionizing radiation sources under Government Resolution No. 45:

• production premises at the place of business, held on a lawful basis and compliant with radiation-safety and sanitary-epidemiological requirements;
• equipment, including radiation sources, and technical documentation; compliant operating, storage and disposal conditions for operation, manufacture and storage activities;
• systems for accounting, production control, physical and radiation protection, and accounting and monitoring of individual exposure doses of employees and the public;
• employees with higher or secondary vocational education and additional professional education in radiation safety, including advanced training of at least 72 hours;
• plans for protecting employees and the public in the event of a radiation accident;
• a sanitary and epidemiological expert conclusion confirming compliance with sanitary rules.

Infectious agents and GMOs under Government Resolution No. 46:

• a biological-safety regime, a sanitary and epidemiological conclusion, trained personnel, and compliant premises and equipment.

• Federal Law No. 99-FZ; Federal Law No. 3-FZ “On Radiation Safety of the Population”; Federal Law No. 52-FZ “On the Sanitary and Epidemiological Wellbeing of the Population”.
• Ionizing radiation sources (generating sources) — Government Resolution No. 45 of 25 January 2022 valid until 1 September 2028.
• Infectious disease agents and GMOs — Government Resolution No. 46 of 25 January 2022 valid until 1 September 2028.

Indefinite.

The general processing time is 45 business days; certain procedures submitted through the Unified Portal of State and Municipal Services may be completed more quickly.

Established by the Tax Code of the Russian Federation at RUB 7,500.