Medicines

Counter of citizens' requests

Import/export of superpotent substances

Procedures of completing import/export of superpotent substances which are not precursors of narcotic drugs and psychotropic substances are regulated by the Decision of the Board of the Eurasian Economic Commission dated May 16, 2012 № 45. The Decision sets a uniform procedure of filing a form for a permission for import, export of 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 within the Eurasian Economic Community in trading with third countries, as well as provides the Recommended Practices for filing a unified form (for 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 within the Eurasian Economic Community in trading with third countries.

The nomenclature of superpotent substances, which are not precursors of narcotic drugs and psychotropic substances covered by the Decision of the Board of the Eurasian Economic Commission dated by August 16, 2012 № 134 “On Regulatory Legal Acts in Non-Tariff Regulation” (Section 2.12) is specified by the Resolutions of the Government of the Russian Federation dated March 16, 1996 № 278 and August 3, 1996 № 930, which could be found in the “Documents” section.

Documents required to obtain the permission for import into the territory of the Russian Federation and export from the territory of the Russian Federation of superpotent substances which are not precursors of narcotic drugs and psychotropic substances are listed in the Order of the Ministry of Health (Minzdrav) of Russia dated May 28, 2014 № 245н “On Approval of Administrative Regulation of the Federal Service for Surveillance in Healthcareand Social Development for the Performance of the State Duty of Issuing the Certificate for Import (Export) of Narcotic Drugs, Psychotropic Substances and Their Precursors”. You can find this list in the “Documents” section. 

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Description of the state service “Issue of permissions for import into/ export from the Russian Federation of superpotent substances which are not precursors of narcotic drugs and psychotropic substances” 

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

Documents submitted by a licensee in person*:

1) a request letter containing the following:

- applicant information: name, legal address of an applicant – a legal entity (for individual entrepreneurs – full name, residential address);

- tax ID number;

- information about a manufacturer and a consumer of superpotent substances which are not precursors of narcotic drugs and psychotropic substances:  name, registered address, postal address of a manufacturer and a consumer of superpotent substances which are not precursors of narcotic drugs and psychotropic substances, tax ID number;

- country of destination of superpotent substances  which are not precursors of narcotic drugs and psychotropic substances;

- country of origin of superpotent substances  which are not precursors of narcotic drugs and psychotropic substances;

- customs point on a border crossing;

- information about a buyer and a seller of superpotent substances which are not precursors of narcotic drugs and psychotropic substances, registered address, postal address, tax ID number;

- country of a buyer and a seller of superpotent substances which are not precursors of narcotic drugs and psychotropic substances;

- permit duration;

- currency of payment;

- conversion rate (in a case currency of a contract is not in USD);

- name and full description of each position of goods (superpotent substances which are not precursors of narcotic drugs and psychotropic substances),

- information about state registration on the territory of the Russian Federation (regarding medicines);

- unit of measurement;

- quantity;

- price per unit (in USD);

- sum total (in USD);

- statistic value (in USD);

- ground for permission request (number and date of a contract for delivery of superpotent substances which are not precursors of narcotic drugs and psychotropic substances);

- number, date and period of validity of license for the applicant’s activity;

- code of the goods according to the Foreign Economic Activity Commodity Nomenclature  of the Customs Union approved by the Customs Union Commission;            

- Full name, position of an applicant or a person authorized by an applicant;

A request letter should be signed and stamped by an applicant;

2) a copy of a contract (agreement) for delivery containing information about conditions of purchasing superpotent substances which are not precursors of narcotic drugs and psychotropic substances and which are specified in application for issue of the permission laced and signed by an applicant or by a responsible party;

3) a copy of a commission agreement in a case an applicant is a legal entity – a commission agent;

4) a submission issued by an authorized healthcare agency confirming expediency of import of superpotent  substances which are not precursors of narcotic drugs and psychotropic substances (only for import of such substances into the territory of the Russian Federation);

5) applicant’s written commitment to present to a territorial body of the Federal Service of the Russian Federation on Supervision over Circulation of Narcotics a report on actual import into the territory of Russian Federation and export from the territory of Russian Federation of superpotent substances which are not precursors of narcotic drugs and psychotropic substances;

6) Notarized copies of constituent documents of an exporter (importer).

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

 

Information received by Roszdravnadzor from interagency cooperation of **:

1) Ministry of Industry and Trade (Minpromtorg) of Russia – information on an applicant from the register of licenses– a legal entity having the license for manufacture of medicines (if superpotent substances imported into the territory of the Russian Federation or exported from the territory of the Russian Federation, are not precursors of narcotic drugs and psychotropic substances, and/or are medicines);

2) Federal Tax Service of Russia (FNS of Russia) – information confirming the registration of an applicant in the Unified State Register of Legal Entities (EGRYUL) or Unified State Register of Individual Entrepreneurs (EGRIP);

3) Ministry of Health (Minzdrav) of Russia:

information about state registration of medicines, containing superpotent substances, which are not precursors of narcotic drugs and psychotropic substances from the State Register of Medicines;

information about registration of manufacturer’s maximum ex-works price for a medicine containing superpotent substances, which are not precursors of narcotic drugs and psychotropic substances (regarding medicines included into the list of vital and essential medicines);

4) Roszdravnadzor – information from the register of licenses to perform pharmaceutical activity (if superpotent substances imported into or exported from the territory of the Russian Federation, which are not precursors of narcotic drugs and psychotropic substances, are medicines).

 ** Documents submitted on applicant’s own initiative

 

Service period

issue of the permission or notification about refusal in the license – 15 working days upon the receipt of the documents by Roszdravnadzor;

issuing of a duplicate of the permission – 5 working days from the date of the receipt of the application by Roszdravnadzor.

 

State duty

free of charge

 

Institution 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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