ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of March 18, 2021 No. 218n

About approval of Administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in issue of the conclusions (allowing documents) for import to the Russian Federation and export from the Russian Federation of the biological materials received when performing clinical trial of medicine for medical application

According to Item 2 of Rules of import to the Russian Federation and export from the Russian Federation of the biological materials received when performing clinical trial of medicine for medical application, approved by the order of the Government of the Russian Federation of September 3, 2010 No. 673 (The Russian Federation Code, 2010, No. 37, Art. 4688; The official Internet portal of legal information (http://pravo.gov.ru), 2020, on December 22 No. 0001202012220021) and the Rules of development and approval of administrative regulations of provision of the state services approved by the order of the Government of the Russian Federation of May 16, 2011 No. 373 "About development and approval of administrative regulations of implementation of the state control (supervision) and administrative regulations of provision of the state services" (The Russian Federation Code, 2011, No. 22, Art. 3169; 2018, to No. 46, of the Art. 7050), I order:

1. Approve the enclosed Administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in issue of the conclusions (allowing documents) for import to the Russian Federation and export from the Russian Federation of the biological materials received when performing clinical trial of medicine for medical application.

2. Declare invalid the order of the Ministry of Health of the Russian Federation of October 29, 2019 No. 900n "About approval of Administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in issue of the conclusions (allowing documents) for import to the territory of the Russian Federation and export out of limits of the territory of the Russian Federation of the biological materials received when performing clinical trial of medicine for medical application" (registration No. 57263) is registered by the Ministry of Justice of the Russian Federation on January 23, 2020.

3. This order becomes effective since July 1, 2021.

Approved by the Order of the Ministry of Health of the Russian Federation of March 18, 2021, No. 218n

Administrative regulations of the Ministry of Health of the Russian Federation on provision of the state service in issue of the conclusions (allowing documents) for import to the Russian Federation and export from the Russian Federation of the biological materials received when performing clinical trial of medicine for medical application

I. General provisions

Subject of regulation of Administrative regulations

1. The administrative regulations of the Ministry of Health of the Russian Federation (further - the Ministry) on provision of the state service in issue of the conclusions (allowing documents) for import to the Russian Federation and export from the Russian Federation of the biological materials received when performing clinical trial of medicine for medical application (further - Administrative regulations), establish terms and the sequence of ministerial procedures (actions) of the Ministry in the course of provision of the state service, order of interaction between structural divisions of the Ministry, his officials, and also interactions of the Ministry with applicants, other public authorities and local government bodies, organizations and the organizations in the course of provision of the state service.

2. The state service is provided concerning samples of biological materials of the person (samples of the biological liquids, fabrics, secrets and waste products of the person, physiological and pathological allocations, dabs, scrapings, washouts, microorganisms, biopsy material) received when performing clinical trial of medicine for medical application, included in Section 2.21 of the Inventory concerning which the allowing procedure for import to customs area of the Eurasian Economic Union and (or) export from customs area of the Eurasian Economic Union is established (the decision of Board of the Eurasian economic commission of April 21, 2015 to No. 30, the Official site of the Eurasian Economic Union of http://www.eaeunion.org/, on April 22, 2015, on October 11, 2019).

3. The state service is provided when importing to the Russian Federation from the third countries and export from the Russian Federation to the third countries of samples of the biological materials of the person received when performing clinical trial of medicine for medical application (further - import (export) of biological materials), for their studying in the Russian Federation and (or) outside the Russian Federation.

Information from the conclusions is provided by the Ministry in customs authorities in electronic form by means of use of single system of interdepartmental electronic interaction.

Circle of applicants

4. Applicants on provision of the state service (further - applicants) are the following legal entities performing the organization of performing clinical trials of medicines for medical application (further - clinical trial):

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