Among the most important changes in the regulation of foreign economic activity in the 1st quarter of 2023, the following can be distinguished:

Among the most important changes in the regulation of the Russian pharmaceutical industry in the 1st quarter of 2023, the following can be distinguished:

Roman Shabrov, partner at BRACE commented for Pharmaceutical Bulletin magazine on the case of an anti-competitive agreement on the Chlorhexedine antiseptic market, identified by the FAS Russia, the resolution of which was appealed by the companies held liable.

In July 2021, the Eurasian Economic Commission issued an update that from July 1, 2021, medicinal products should be registered according to the unified rules of the EAEU. These rules were approved by the Decision of the Council of the Economic Commission dated 03.01.2017 No. 78 “On the rules for registration and examination of medicines for medical use”. At the same time, for the Russian Federation, the establishment of compulsory registration under the EAEU Rules was carried out from January 1, 2021.

Recall that earlier by Appendix No. 5 to the Rules of Compulsory Medical Insurance, approved by order of the Ministry of Health of the Russian Federation No. 108n dated February 28, 2019, determining the coefficients of the amount of non-payment or incomplete payment of the costs of a medical organization for the provision of medical care as a basis for non-payment and incomplete payment it was established that the patient or his representative purchased medicinal products for medical use, included in the list of vital and essential medicinal products, and (or) medical products included in the list of medical products implanted into the human body, on the basis of clinical guidelines, taking into account the standards of medical care and / or the use by a medical organization of drugs provided by a patient or another organization acting in the patient’s interests, from other sources of funding (with the exception of the provision of medical care on an outpatient basis).

By the Decree of the Government of the Russian Federation of June 30, 2021 No. 1069 “On Amendments to the Regulation on the Monitoring System for the Movement of Medicinal Products”, this period was determined until February 1, 2022. Thus, the simplified procedure for working in the medicinal product labeling and tracking system in Russia is prolonged for another 7 months.

Decree of the Government of the Russian Federation of June 29, 2021 No. 1049 “On federal state control (supervision) of medicinal products circulation” approved a new Regulation on federal state control (supervision) in the field of drug circulation (hereinafter referred to as the “Regulation”). The Regulation entered into force on 01.07.2021. At the same time, the Decree of the Government of the Russian Federation of October 15, 2012 No. 1043 “On Approval of the Regulation on Federal State Supervision in the Sphere of Medicines Circulation” and a number of other Government acts were declared invalid.

Decree of the Government of Russia dated 01.06.2021 No. 853 approved new Rules for the import of medicines for medical use into the Russian Federation and invalidating some acts and certain provisions of some acts of the Government of the Russian Federation and invalidated the Decree of the Government of the Russian Federation dated 29.09.2010 No. 771 “On the procedure for importing medicines for medical use into the territory of the Russian Federation”. From September 1, 2021, the new rules for the import of medicines into the territory of Russia will take effect.

On December 10, 2021, the Recommendation of the Board of the Eurasian Economic Commission dated June 8, 2021 No. 11 “On the Guidelines for the Transfer of Technologies and (or) Analytical Methods in the Production of Medicines” comes into force.

The Rules for ensuring the provision of medical care (if necessary outside the Russian Federation) to a specific child with a serious life-threatening or chronic disease, including a rare (orphan) disease, or to groups of such children (hereinafter – the “Rules”) were approved by Decree of the Government of Russia dated May 21, 2021 No. 769.