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BRACE Law Firm renders legal services to corporate and private clients on issues of Russian and international law. The basis of our practice is dispute resolution and litigation. At the same time, our areas of expertise include such areas of legal practice as support of commercial activities, antitrust law, real estate...

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A new regulation on state control of medicinal products circulation

11-07-2021

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...

New rules for the import of medicinal products into the territory of Russia have been adopted

11-07-2021

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...

The EAEU Collegium approved the Guidelines for Technology Transfer in the Production of Medicinal Products

11-07-2021

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 the provision of medical care to children with severe and rare diseases were approved

10-06-2021

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.

New procedure for the import and export of potent and toxic substances

10-06-2021

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...

Subsidized certification of Russian medicines supplied to foreign markets has been launched

14-05-2021

Resolution of the Government of Russia dated April 30, 2021, No. 687 “On state support of organizations to compensate for part of the costs associated with the certification of products, including products of the pharmaceutical and medical industry, in foreign markets” (hereinafter – “Resolution No. 687”) sets goals, conditions and procedure the provision of subsidies from the federal budget to...

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