ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

of December 5, 2022 No. 777n

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 March 14, 2022 No. 363 "About approval 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, and recognition voided some acts and separate provisions of some acts of the Government of the Russian Federation" (The Russian Federation Code, 2022, No. 12, the Art. 1848), and also the order of the Government of the Russian Federation of March 24, 2022 No. 454 "About features of the organization of provision of the state services, and also developments and adoptions of administrative regulations of provision of the state services in 2022" (The Russian Federation Code, 2022, No. 13, Art. 2114; No. 36, the Art. 6214), the order of the Government of the Russian Federation of July 20, 2021 No. 1228 "About approval of Rules of development and approval of administrative regulations of provision of the state services, about introduction of amendments to some acts of the Government of the Russian Federation and recognition voided some acts and separate provisions of acts of the Government of the Russian Federation" (The Russian Federation Code, 2022, 31, of the Art. 5904) I order to No.:

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 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" (registration No. 64040) is registered by the Ministry of Justice of the Russian Federation on June 30, 2021.

Approved by the Order of the Ministry of Health of the Russian Federation of December 5, 2022, No. 777n

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 the 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, scrapes, washouts, microorganisms, biopsiyny 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 approved by the Decision of Board of the Eurasian economic commission of April 21, 2015 No. 30 "About measures of non-tariff regulation" <1> is established.

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<1> The official site of the Eurasian Economic Union of http://www.eaeunion.org/, on April 22, 2015, became effective on May 22, 2015. Is obligatory for the Russian Federation according to the Agreement on the Eurasian Economic Union of May 29, 2014 ratified by the Federal Law of October 3, 2014 No. 279-FZ "About ratification of the Agreement on the Eurasian Economic Union" (The Russian Federation Code, 2014, No. 40, the Art. 5310) (The agreement became effective for the Russian Federation on January 1, 2015).

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 <2>.

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