The Government of the Russian Federation has approved the plan of transition of federal executive bodies to the implementation of priority state functions on issuing permits in electronic form. Order of the Government of the Russian Federation No. 218-r dated February 6, 2020 was published on the static.government.ru portal. The plan provides for an accelerated transition of 15 ministries and agencies to the issuance of permits
The state service “Issuance of permits for import into the territory of the Russian Federation of medical devices for the purposes of their state registration” should switch to electronic form. It will be allowed both to submit an application for public service and the documents attached thereto, and to receive the result of public service provision in electronic form on a single portal of state and municipal services without mandatory personal visit of a state authority or multifunctional centers for provision of state and municipal services for submission of original documents.
By June 1, 2020 amendments will be made to the Order of the Ministry of Health of Russia from June 15, 2012 No. 7n “On Approval of the Order of import into the territory of the Russian Federation of medical devices for state registration”, and by December 25, 2020 pilot operation and provision of public services in electronic form on a single portal of state and municipal services should be conducted.
Also, the procedure “Issuance of permits for import into the territory of the Russian Federation of a specific batch of registered and/or unregistered medicinal products intended for clinical trials of medicinal products, of a specific batch of medicinal products intended for conducting expert examination of medicinal products for the purposes of state registration of medicinal products, of a specific batch of medicines to provide life-saving medical care for a specific patient” will be transformed.
Relevant amendments will be made to the Resolution of the Government of the Russian Federation No. 771 of September 29, 2010 “On the Procedure for Import of Medicines for Medical Use into the Russian Federation” by July 30, 2020. Test operation and provision of the state service in electronic form on the unified portal of state and municipal services should take place on October 1, 2021.
With regard to the procedure of “Issuance of permits for import into the territory of the Russian Federation and export outside the territory of the Russian Federation of biological materials obtained in the course of clinical trial of medicinal product for medical use”, adjustments will be required to the Decree of the Government of the Russian Federation of September 3, 2010 № 673 “On approval of the Rules for import into the territory of the Russian Federation and export outside the territory of the Russian Federation of biological materials obtained in the course of clinical trials of medicinal product for medical use”. The deadline is September 30, 2020. Pilot operation and provision of the public service in electronic form is scheduled for October 30, 2021.