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.
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”.
Decree of the Government of Russia dated 06.04.2021 No. 545 approved the Procedure for the acquisition of medicinal products, medical devices and technical means of rehabilitation for a specific child with a serious life-threatening and chronic disease, including a rare (orphan) disease, or for groups of such children (hereinafter referred to as the “Procedure”).
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 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, within the framework of the federal project “Industrial Export” of the national project “International Cooperation and Export”.
The Russian Ministry of Health has developed a draft Rules for the Dispensing of Medicines for Medical Use” (project ID 01/02 / 04-21 / 00114788) (hereinafter referred to as the Rules).
- Roman Shabrov, attorney at BRACE, spoke at the PHARMAPAK forum
- The courts have determined the interchangeability of the drug “Kashnol” on the basis of data from the State Register of Medicines
- Webinar on the topic: “The practice of reducing costs and risks during transportation and storage of medicinal products”
- The rules for the destruction of seized falsified, substandard and counterfeit medical devices have been approved