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*:
To obtain the certificate:
1. An application for issue of the certificates for import (export) of narcotic drugs, psychotropic substances and their precursors
2. If it is provided by the law of an importing country, a copy of permission issued by an authorized body of this country for import of a particular batch of narcotic drugs and psychotropic substances or their precursors in the territory of this country. Otherwise, an official note issued by this body and confirming that this permission is not required.
3. A copy of a foreign trade contract (agreement) related to narcotic drugs, psychotropic substances or their precursors or a commission agreement (if an applicant is a commission agent).
4. A copy of certificate or of any other document confirming quality of a narcotic drug, psychotropic substance or a precursor (it they are medicines). If narcotic drugs, psychotropic substances or precursors intended for import are not manufactured by the date of submission, the copy should be submitted to Roszdravnadzor within 10 days from the date of their import.
5. A copy of a document confirming the powers of a head of organization or of another person who signed an application to act on behalf of an applicant: a decision on appointment or election of a CEO or another person to his/her position, and an extract from applicant’s constituent documents in accordance to which a CEO or another officer is entitled to act on behalf of an applicant without a letter of authorization. If another person acts on behalf of an applicant, a letter of authorization to act on behalf of an applicant signed by an applicant or a person authorized by him should be submitted. The letter of authorization signed by an authorized person should be accompanied with a document confirming the powers of the authorized person.
To reissue certificate due to change of a type of a legal entity, name or address of an applicant after making appropriate changes in the Unified State Register of Legal Entities:
1. An application for reissue of the certificate;
2. Copies of documents confirming the changes.
To reissue the certificate due to a mistake in it:
1. An application for reissue of the certificate addressed to the Head of Roszdravnadzor.
To obtain a duplicate of the certificate:
1. An application addressed to the Head of Roszdravnadzor for issuing a duplicate of the certificate stating circumstances of its loss.
To cancel the certificate:
1. An application addressed to the Head of Roszdravnadzor for cancellation of the certificate stating the reason for the cancellation of the issued certificate.
* Each page (or sheet if written on both sides) of the copies of submitted documents should be signed and sealed by an applicant or the copies of all documents should be laced, signed and sealed by an applicant.
Information received by Roszdravnadzor via interagency cooperation**:
1. Information about legal entity (individual entrepreneur) contained in the Unified State Register of Legal Entities (Unified State Register of Individual Entrepreneurs).
2. Documents confirming state registration of a medicine in case of import (export) of medicines.
3. Documents confirming state registration of manufacturer’s maximum sale prices for imported medicines included into the list of vital and essential medicines, which is annually approved by the Government of the Russian Federation.
3. License for manufacture of medicines (in a case of import-export of medicines).
4. License for pharmaceutical activity (in a case of import-export of medicines).
5. License for circulation of narcotic drugs, psychotropic substances and their precursors, for cultivation of drug-containing plants
** Documents submitted on applicant’s own initiative.
issue of the certificate – 30 days from the date of the receipt of the applications and copies of documents by Roszdravnadzor,
reissue of the certificate - 15 days from the date of the registration in Roszdravnadzor the application and copies of documents;
issue of a duplicate of the certificate - 15 days from the date of registration in Roszdravnadzor the application and copies of documents;
cancellation of the certificate –
a) 10 days from the registration of the application in Roszdravnadzor;
b) 5 days from the date of registration of information submitted in written form by an authorized body of an importing country on that the certificate presented by an applicant has not been issued, has been cancelled or contains unreliable data;
c) 5 days from the date of the registration in Roszdravnadzor the information about court decision on cancellation of the license for activity related to circulation of narcotic drugs and psychotropic substances or to circulation of precursors included into Table 1 of List IV.
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.
Call center: +7 (499) 578-02-30, +7 (495) 698-45-38.