Licensing of medical activities in Russia

2021: The Ministry of Health has promulgated new rules for licensing medical activities in Russia

In August 2021, the Ministry of Health of the Russian Federation introduced new rules for licensing medical activities in the country. The document entered into force on March 1, 2022, it will be valid for six years. At the same time, points 3 and 4 will work earlier - in September 2021.

Paragraph 3 refers to the exclusion of rehabilitation nursing from the list of work and services constituting medical activities. Paragraph 4 supplements this list of identical works and services constituting medical activities with the positions of "health organization and public health" and "epidemiology."

Ministry of Health introduced new rules for licensing medical activities in the Russian Federation

The new resolution clarified the requirements for obtaining a license for medical activities on organ transplantation. Now they have the right to receive only state and municipal clinics. At the same time, a feature applies - first, institutions receive a license to operate, then apply to the Ministry of Health with an application for inclusion in the list of specialized clinics.

The new document on licensing medical activities provides for the exclusion of certain types of licensed medical services, but the draft order, published after the approval of the decision, proposes to exclude rehabilitation nursing in addition to the approved list.

Heads and deputies of organizations included in the system of federal sanitary and epidemiological supervision should also have higher medical education, accreditation of a specialist, additional vocational education in the specialty "Social Hygiene and Organization of the State Health Service."

In addition, individual entrepreneurs who want to obtain a license must have secondary medical education and accreditation of a specialist if they intend to provide primary care. The work experience of the above persons in the presence of higher medical education should be at least five years and at least three years in the presence of secondary medical education.^[1]

2020: Licensing of medicine and pharmaceuticals is translated completely into electronic format

Licensing of medicine and pharmaceuticals is translated completely into electronic format. This was announced on November 30, 2020 by Prime Minister Mikhail Mishustin, opening an operational meeting with deputy prime ministers.

We translate into numbers, simplify and make it more convenient for people to license several widespread activities at once. For them, from January 1, 2021, the so-called registry model for the provision of public services with a complete rejection of paper is being introduced, the head of government said.

According to him, licenses in electronic form will be issued in the field of medical, pharmaceutical activities, for the production of medicines, medical equipment and its service.

Licensing of medicine and pharmaceuticals in the Russian Federation is completely translated into electronic format

Mishustin noted that obtaining the necessary documents will take less time than it was before, and the process itself will become as transparent as possible.

At the same time, access to the license register is open and public. At the same time, entries in license registers made before the day of its entry into force are subject to bring into accordance with this law by January 1, 2022. Licenses issued prior to the effective date of this Law shall confirm that the licensee has a license on the effective date of this Law.

In September 2020, the Government of the Russian Federation approved new rules for licensing the production and maintenance of medical equipment. Manufacturers and companies engaged in the maintenance of medical equipment will have to re-issue the profile license according to the new rules until December 31, 2023.

Specialists of the Federal Antimonopoly Service (FAS) of Russia over the past few years point to another problem - the lack of licensing requirements for medical activities. The FAS is trying to oblige the Ministry of Health to develop such requirements, the last time the service commission determined the department another deadline - until December 1, 2020.^[2]

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