On 8 March 2022, Federal Law No. 46 “On Amending Certain Legislative Acts of the Russian Federation” entered into full force and effect, suggesting considerable changes in regulations and intellectual property in the pharmaceutical sphere.

On March 04, 2022, the Council of Federation has approved and sent to the President the Federal Law “On Amending Certain Legislative Regulations of the Russian Federation” (the “Law”). This Law provides for a number of changes in the regulation of procurement and circulation of medical products (“MP”) and medical devices (“MD”), corporate and financial relations, and even social matters.

The Russian Government brought a draft law “On amendments to the Part IV o the Russian Civil Code” to the State Duma. 

Amendments to the Federal Law “On fundamental healthcare principles in the Russian Federation” will come into force on June 29, 2022, allowing doctors to prescribe off-label drugs to minors, i.e. for indications not specified in their instructions for use.

In December 2021, new amendments to the Law “On Veterinary Medicine” and the Federal Law “On Circulation of Medicines” in terms of the procedure for circulation of medicinal drugs for veterinary use were adopted.

Council of the Eurasian Economic Commission considered amendments to the Agreement on Uniform Principles and Rules for Circulation of Medical Devices (Medical Devices and Medical Equipment) from 23 December 2014 regarding prolongation of national registration till 31 December 2022.

Ministry of Industry and Trade prepared a draft on amending the Regulations of the Russian Government No. 1289 of 30 November 2015. Under the draft the drugs from the List of Strategically Important Drugs produced in a foreign country shall be rejected to supply by the customer if there is at least one offer to supply a drug produced (all manufacturing stages) exclusively in the territory of the Eurasian Union member states.

During the meeting with foreign companies on 16 September 2021, the Ministry of Economic Development announced that it prepared a draft law on the Register of the pharmaceutically active ingredients protected by patents.

From September 1, 2021, amendments to the Rules for issuing Permits for the Retail Sale of Medicines for Medical Use by remote Means, the Implementation of such sale and the delivery of medicines to Citizens, approved by the Decree of the Government of the Russian Federation dated 31.05.2021 N 827 (hereinafter – the Rules), came into force.

From 1 January 2022, the registration of medical devices will proceed only under the Eurasian Economic Union rules.