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
- 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
free of charge
Institutions for documents submission, working hours, contacts, responsible officers
4, bld.1 Slavyanskaya Square, Moscow, 109074.
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.
+7 (499) 578-02-30, +7 (495) 698-45-38.