Latest legislative initiatives in the Life Sciences sector impacting foreign manufacturers

There are plans to:

• prohibit manufacturers and distributors of medical devices from leaving the Russian market without at least six months prior notice; and
• permit the sale of foreign medicines in their original packages.

Exit notice for manufacturers and distributors of medical devices

The Russian government has developed and introduced to the State Duma a bill* to amend the laws “On the basics of public health protection in the Russian Federation”, “On the circulation of medicines” and “On the contract system in the procurement of goods, works, services for state and municipal needs”. 

To reduce the risk of unavailability of medical devices and the threat to the life and health of citizens (including due to untimely provision of medical care), there are plans to prohibit manufacturers and distributors of medical devices from suspending or terminating the production of medical devices or their import into Russia without giving the Russian Ministry of Health no less than six months’ notice.

Sale of foreign medicines in their original packages

It is proposed to accelerate the process of putting newly-registered medicines on the Russian market. In case of their shortage (or the risk of shortage) while sanctions are in place, it will be possible to import medicines, put them on the market and use them in Russia in the original (i.e. foreign) packaging without a Russian translation.

The relevant bill* has already passed first reading and, if adopted, will come into force on the date of its official publication. Given the promptness of the adoption of counter-sanctions in Russia, the adoption of this law can be expected in the coming days.

* In Russian