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Main  >  News  >  A number of permits in the field of drug circulation in electronic form

A number of permits in the field of drug circulation in electronic form

02/12/2020 | drug research, Ministry of Health of Russia, Roszdravnadzor, pharmaceutical activities

The Government of the Russian Federation approved a plan for the transition of federal executive bodies to the execution of priority state functions for issuing permits in electronic form. Decree of the Government of the Russian Federation dated February 6, 2020 No. 218-r was published on the portal static.government.ru. The plan provides for an accelerated transition of 15 ministries and departments to the issuance of permits for 47 most demanded public services and business representatives.

One of the points of the document is the translation of the accreditation procedure of specialists in order to obtain the right to carry out medical activities and pharmaceutical activities in electronic form. The plan stipulates that the results of accreditation can be obtained in your personal account on the Unified Portal of the State Service without a mandatory visit to the MFC or public authority. Also, an extract from the Federal Register of Medical Workers on accreditation will be issued automatically, without the participation of a person, which will reduce the time for obtaining the right to carry out activities from 30 days to 1 business day.

To this end, the Ministry of Health, by the end of 2020, should prepare and amend Federal Law 323 of the Federal Law “On the Basics of Health Protection” and Order No. 334n “Regulation on the Accreditation of Specialists”, which will allow keeping a register of all pharmaceutical and medical specialists in the Unified Information System in the field of health care. The development of such amendments began at the end of last year. According to the government’s plans, it will be possible to receive an extract on accreditation through the State Services Internet portal from July 1, 2021.

Also, the public service “Issuing permits for the import of medical devices into the Russian Federation for the purpose of their state registration” should go into electronic form. Both the submission of an application for the provision of public services and the documents attached to it will be allowed, as well as the receipt of the results of the provision of public services in electronic form on a single portal of state and municipal services without a mandatory personal visit to a public authority or multifunctional centers for the provision of state and municipal services for the presentation of original documents.

Until June 1, 2020, amendments will be made to Order No. 7n of the Ministry of Health of June 15, 2012 “On Approving the Procedure for the Importation of Medical Devices into the Russian Federation for State Registration,” and on December 25, 2020, trial operation and ensuring the provision of public services in electronic form on a single portal of state and municipal services.

Procedure “Issuing permits for the import into the territory of the Russian Federation of a specific consignment of registered and (or) unregistered medicinal products intended for conducting clinical trials of medicinal products, a specific consignment of medicinal products intended for conducting examination of medicinal products for the purpose of state registration of medicinal products, a specific consignment life-saving medications specifically “patient” will also undergo a transformation.

By July 30, 2020, relevant amendments will be made to the Decree of the Government of the Russian Federation of September 29, 2010 No. 771 “On the Procedure for the Importation of Medicines for Medical Use into the Territory of the Russian Federation”. The trial operation and provision of the provision of public services in electronic form on a single portal of state and municipal services should take place on October 1, 2021.

As for the procedure “Issuance of permits for the 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 a clinical trial of a medicinal product for medical use”, corrections to the decree of the Government of the Russian Federation dated September 3, 2010 No. 673 “On approval of the Rules for the import into the territory of the Russian Federation and export outside the territory of the Russian Federation of biological materials obtained under and conducting a clinical trial of a medicinal product for medical use. " The deadline is September 30, 2020. Pilot operation and provision of the provision of public services in electronic form is scheduled for October 30, 2021.

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