Medicines

Roszdravnadzor performs the state service for issuing to legal entities approvals on import/export of human organs and tissues, blood and its components with the exception of import/export of samples of cells, tissues, biological fluids, secretions and  metabolic byproducts, physiological or pathologic discharges, swabs, scrapes, lavages intended for diagnostic and scientific purposes during biological and medical investigations. 

The Decision of the Board of the Eurasian Economic Commission dated August 16, 2012  № 134 “On Regulatory Legal Acts in Non-Tariff Regulation” includes section 2.21 “Human Organs and Tissues, Blood and Its Components Restricted to Movement across the Customs Border of the Customs Union  while Importing and (or) Exporting”, which lists the goods subject to restrictions. You can find this document in the “Documents” section.

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

 In the section “Documents” you can find the Order of Ministry of Healthcare and Social Development (Minzdravsotsrazvitiya) of Russia 1471н dated December 5, 2011 №  “On Approval of the Federal Service for Surveillance in Healthcareand Social Development Administrative Regulation  on Provision with the State Service of Approval of the Issue of Licenses for Export and (or) Import of Human Organs and (or) Tissues, Blood and Its Components”, which lists the documents required by Roszdravnadzor to issue of an approval for granting a license for export and (or) import of human organs and (or) tissues, blood and its components.

In this section you can find regulatory acts, specifying requirements for import (export) of human organs and tissues and informative letters of Roszdravnadzor about the results of provision of this service.

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 issue of an approval for export (import) of human organs and (or) tissues, blood and its components.

2. An electronic copy of an 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;

3. A copy of a foreign trade agreement (contract), annexes and (or) supplements thereto, in a case of absence of a foreign trade agreement (contract) – a copy of any document confirming intentions of the parties.

4. Permissions issued by state authorities of third countries empowered to take decisions on the possibility of import or export of human organs and (or) tissues, blood and its components. 

* 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. Information about a legal entity (individual entrepreneur) from the Unified State Register of Legal Entities (Unified State Register of Individual Entrepreneurs).

2. License for manufacture of medicines (in a case of use in production).

3. License for medical activity.

** Documents submitted on applicant’s own initiative

 

Service period

- issue an approval of possibility of granting a license for the import of human tissues, blood and its components   - within three working days from the date of registration of documents  submitted by an applicant to Roszdravnadzor;

– issue an approval for the import and (or) export of human organs   - within one working day from the date of 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, 109012.

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.