New Rules for the destruction of seized counterfeit medicines, substandard and counterfeit medicines (hereinafter – Rules for the destruction of medicinal products) were approved by the Decree of the Government of Russia dated September 15, 2020 No. 1447.
Decree of the Government of Russia dated October 1, 2020 No. 1583 approved the Rules for the circulation of generic drugs and biosimilars until the end of the period established for conducting studies of their bioequivalence or therapeutic equivalence (hereinafter – the Rules), which entered into force on October 5, 2020.
On September 8, 2020, the Administrative Regulations of the Federal Service for Surveillance in Healthcare on the provision of state services for issuing a permit for the retail sale of medicinal products for medical use remotely, approved by order of the Federal Service for Surveillance in Healthcare N 5161 (hereinafter referred to as the “Administrative Regulations”), came into force.
On September 28, 2020, new rules for determining the maximum size of wholesale and retail markups to the actual selling prices of manufacturers of medicines included in the vital and essential drugs list came into force.
On August 31, 2020, the decree of the Ministry of Health of the Russian Federation of May 15, 2020, N 450n “On approval of the procedure for determining the initial (maximum) contract price, the price of a contract concluded with a single supplier (contractor, performer), and the initial unit price of goods” came into force, work, services in the procurement of medical products.
- A number of legal acts in the field of circulation of medical devices fell under the regulatory guillotine
- The order of putting drugs for medical use into circulation until January 1, 2021, has been approved
- The Ministry of Health has developed a procedure for maintaining a register of citizens entitled to subsidized medicines
- Supervision over the circulation of medicinal products and medical devices have been included in the experiment on pre-trial online appeal of decisions of control authorities