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.
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.
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.
A draft order of the Ministry of Health has been developed “On Amending the List of Diseases and Conditions and Corresponding Medicines Containing Narcotic Drugs or Psychotropic Substances in order to import them into the territory of the Russian Federation for the provision of health care according to the vital indications of a specific patient or group of patients, approved by the order of the Ministry Healthcare of the Russian Federation No. 80n dated February 13, 2020”.
- Subsidized certification of Russian medicines supplied to foreign markets has been launched
- The Government has settled the purchase of medicinal products for children with severe life-threatening and chronic diseases
- The Ministry of Health of Russia proposes to establish new rules for the dispensing of medicinal products
- Roman Shabrov, attorney at BRACE, spoke at the PHARMAPAK forum