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.
According to the new rules, participants in the pharmaceutical market will be able to apply for permits to import medicines into Russia through the Unified Portal of Public Services.
It is allowed to import medicines into the territory of the Eurasian Economic Zone that are entered in the Unified Register of Registered Medicines of the EAEU or in the corresponding register of a member state of the Union. When importing, it is necessary to comply with the requirements that are established by each country that is a member of the EAEU.
The following persons will be able to import medicines into Russia:
- manufacturers of medicinal products for the purposes of their own production;
- organization of wholesale trade in medicines;
- foreign developers of medicines and foreign manufacturers of medicines for clinical trials of a medicinal product, registration and examination of medicines intended for circulation in Russia or on the territory of the EAEU;
- research organizations, educational institutions of higher education and manufacturers of medicinal products for the development, research, control of the safety, quality and efficacy of medicines in the presence of a conclusion;
- medical organizations, as well as organizations listed above, for the provision of medical care according to the vital indications of a particular patient or for the provision of medical care to a limited contingent of patients with rare and (or) especially severe pathology in the presence of a conclusion.
It is stipulated that in Russia for the import of medicinal products, with the exception of certain cases, the conclusion of the Ministry of Health is required. The application for such a permit and the results of the decision made are registered in a special register, and the documents themselves are submitted in electronic form.
The grounds for refusal to issue an opinion are:
- presence of incomplete or inaccurate information in the documents submitted by the applicant to obtain an opinion;
- medicinal product declared for import into Russia for medical use is prohibited for medical use on the territory of the EAEU;
- legal entity that submitted the application and documents for the purpose of obtaining an opinion is not indicated in the relevant act of the Government of the Russian Federation as a person authorized to import a medicinal product not registered in the Russian Federation to provide medical care to a limited contingent of patients with rare and (or) especially severe pathology.
The import of a medicinal product not registered in Russia for the provision of medical care to a limited contingent of patients with rare and (or) especially severe pathology is carried out on the basis of the opinion of the Ministry of Health prepared in pursuance of an act of the Government of the Russian Federation, which specifies the legal entity importing the INN of the imported medicinal product , its forms, dosages, volumes to be imported, as well as the disease (condition) of patients, for a limited contingent of whom the drug is imported.
The new procedure does not apply to the import of narcotic drugs and psychotropic substances, in respect of which there is a special import procedure.
It is prohibited to import falsified, substandard, counterfeit medicines into the country.
July 11, 2021