Medicines

Counter of citizens' requests

Import/export of hematopoietic stem cells and bone marrow

By the Order of the Government of the Russian Federation dated September 23, 2010 № 1567-р Roszdravnadzor is vested with the power to issue approval for import/export of human organs and tissues, blood and its components.

The Decision of the Board of the Eurasian Economic Commission dated by August 16, 2012  № 134 “On Regulatory Legal Acts in the Field of Non-Tariff Regulation” includes section 2.21 “Human Organs and Tissues, Blood and Its Components Restricted for Carrying across the Customs Border of the Customs Union while Importing and (or) Exporting”, which specifies a list of goods subject to restrictions.  Customs formalities regarding import/export of hematopoietic stem cells and bone marrow for the purposes of allotransplantation are subjected to regulations specified by the Regulation for the procedure of import into the territory of the Customs Union and export from the territory of the Customs Union of human organs and (or) tissues, blood and its components, which is approved by the Decision. 

By the Decision of the Board of the Eurasian Economic Commission dated May 16, 2012 № 45 the unified form of a permission for import, export and transit of certain goods included into the Unified list of goods subject to bans and restrictions for import or export by the member states of the Customs Union within the Eurasian Economic Community when trading with third countries. The document also contains the Recommended Practices for filing the unified form of permission for import, export and transit of certain goods included into the Unified list of goods subject to bans and restrictions for import or export by the member states of the Customs Union within the Eurasian Economic Community in trading with third countries.

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Description of the state service “Issue of permit to import into the territory of the Russian Federation and export from the territory of the Russian Federation of hematopoietic stem cells and bone marrow for the purposes of allotransplantation”.

Documents received on paper from an applicant /Documents received in electronic form via the electronic system of interagency cooperation

Documents submitted by a licensee personally*:

1) an application for the license, containing the following:

– desirable term of the permit (not exceeding one year);

– a person, responsible for notifying Roszdravnadzor about any case of carrying of hematopoietic stem cells and bone marrow for the purposes of allotransplantation according to the procedure established by the Decision of the Commission of the Customs   Union dated 25. 01. 2012, № 919.

2) An electronic copy of the application in the form approved by the Board of the Customs Union and created by means of software developed by the Commission of the Customs Union and distributed among the participants of foreign trade free of charge.

An applicant may use his/her own software, which creates an electronic copy of the application in strict accordance to the customs format approved by the Commission;

* Each sheet of the copies presented should be signed and stamped by an applicant or the copies should be laced and signed and stamped by an applicant.

Information received by Roszdravnadzor via interagency cooperation**:

1) about applicant’s tax registration;

2) Information, confirming that an applicant holds a license for medical activity, which includes such services as performance of  allotransplantation, involving  hematopoietic stem cells and bone marrow. 

** Documents submitted on applicant’s own initiative

 

Service period

Issue of the permit – within three working days from the date of the registration of documents submitted by an applicant to Roszdravnadzor 

               

State duty

free of charge

 

Institutions for documents submission, working hours, contacts, responsible officers

Postal address:

4, bld.1 Slavyanskaya Square, Moscow, 109074.

Working hours:

Monday to Thursday: 9:00 am -  6:00 pm

Friday: 9:00 am – 4:45 pm;

Lunch break: 1:00 pm – 1:45 pm.

For more information, call:

+7 (499) 578-01-26 Trapkova Alla;

+ 7 (499) 578-01-27 Tarasova Svetlana;

Fax: +7(495) 698-15-73.

E-mail: info@roszdravnadzor.ru.

Call center:    

+7 (499) 578-02-30, +7 (495) 698-45-38.

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