On licensing requirements for medical activities

INFORMATION LETTER OF 05/28/2020 No. 01I-981/20

FEDERAL HEALTH SUPERVISION SERVICE
(ROSZDRAVNADZOR)

Legal entities, individual entrepreneurs engaged in medical activities

Licensing authorities of the constituent entities of the Russian Federation

Territorial bodies of Roszdravnadzor for the constituent entities of the Russian Federation

On licensing requirements for medical activities

The Federal Service for Supervision of Healthcare informs interested parties that from July 1, 2020, changes in licensing requirements will come into force when legal entities and individual entrepreneurs carry out medical activities.

By the Decree of the Government of the Russian Federation of 05.15.2020 No. 688 “On Amending Clause 5 of the Regulation on the Licensing of Medical Activities (with the exception of the specified activities carried out by medical organizations and other organizations that are part of the private healthcare system in the territory of the Skolkovo Innovation Center)” amendments were made to paragraph 5 of the Regulation on the licensing of medical activities (with the exception of the specified activities carried out by medical organizations and other organizations that are part of the private healthcare system in the territory of the Skolkovo innovation center), approved by Decree of the Government of the Russian Federation of April 16, 2012 No. 291.

Thus, the licensing requirements for medical organizations in carrying out their medical activities are supplemented by the requirement to comply with Part 7 of Article 67 of Federal Law dated 12.04.2010 No. 61-FZ “On the Circulation of Medicines”: legal entities and individual entrepreneurs engaged in production and storage , the importation into the Russian Federation, the vacation, sale, transfer, use and destruction of medicines for medical use, is ensured in the order and composition established by the Government of the Russian Federation, taking into account the type of activity they carry out, entering information about medicines for medical use into the system monitoring the movement of drugs for medical use.

Head of the Federal Service for Health Supervision
A.V. Samoilova