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The Ministry of Industry and Trade of Russia performs licensing of the manufacture of drugs for medical use in accordance with the approved Administrative Regulations (the Order of the Ministry of Industry and Trade of Russia dd. June 07, 2013 No. 877 «On approval of the Administrative Regulations of the Ministry of Industry and Trade of the Russian Federation for the provision of public service of licensing of manufacture of drugs for medical use»)

List of documents

1. To obtain a license for manufacture of drugs for medical use:

  1. A license application signed by a head of a legal entity’s permanent executive body or by another person authorized to act on behalf of such legal entity (hereinafter — the license application), which specifies:
    • Full and abbreviated (if available) name, including the corporate identification and the legal form of a legal entity;
    • The address of its location;
    • The addresses of locations of the licensed activity, which the license applicant intends to exercise;
    • The state registration number of a record on foundation of a legal entity and details of a document confirming the fact of entering the information about a legal entity to the Unified State Register of Legal Entities, with indication of the address of the body that conducted the state registration;
    • Telephone and the e-mail addresses (if available) of a legal entity;
    • Taxpayer identification number, data of the document about the license applicant’s registration with the tax authority;
    • The licensed activity — the manufacture of drugs for medical use, with indicating the list of works that constitute the activities of manufacture of drugs for medical use;
    • Details of a document confirming the payment of a state fee for granting the license, or other information confirming the payment of a specified state fee;
    • Details of a document (name of a body (an organization) which issued the document, date, number), confirming the license applicant’s right of ownership or other legal basis for use of the facilities, buildings, constructions and other objects needed to carry out the activities of manufacture of drugs;
  2. The license application shall be accompanied by:
    • Copies of a legal entity’s constituent documents certified by a notary;
    • Copies of documents confirming the license applicant’s right of ownership or other legal basis for use of the facilities, buildings, constructions and other objects, instrumentalities, equipment, and technical documentation needed to carry out the activities of manufacture of drugs and complying with the established requirements, in relation to which the rights are not registered in the Unified Public Register of Real Property Titles and Transactions (in case if such rights are registered in the above register, the information about such buildings and facilities shall be specified in the application), as well as copies of title pages of industrial regulations;
    • Copies of documents confirming the education, qualification and work experience of an authorized person of the manufacturer of drugs for medical use, as well as the education of specialists responsible for manufacture and labeling of drugs, which comply with the licensing requirements;
    • The record statement of documents attached.

2. For re-licensing of the manufacture of drugs for medical use, in case of reorganization of a legal entity, change of its name, address of its location and addresses of the locations of a legal entity’s licensed activity, the list of the works performed, services rendered, that constitute the licensed activity, the following documents shall be submitted by a licensee, the licensee’s successor or another person as specified by federal law:

  1. The re-licensing application;
  2. The original of a current license;
  3. The record statement of documents attached;
  4. The document confirming the payment of the state fee.

The applicant is entitled to present details of a document confirming the payment of a state fee for re-licensing, or other information confirming payment of the specified state fee.

The licensee shall specify in the re-licensing application:

  1. In case of reorganization of a legal entity in the form of reconstruction, the re-licensing application shall specify any new information about the licensee or the licensee’s successor, under Sub-clause 1 of Clause 27 of these Administrative Regulations, and the data of a document confirming the appropriate changes to have been entered in the Unified State Register of Legal Entities. The re-licensing application and the documents attached shall be submitted to the Ministry of Industry and Trade of Russia within fifteen working days, after the date, the appropriate changes are made in the Unified State Register of Legal Entities on;
  2. In case if a legal entity’s name or its location is changed, the re-licensing application shall specify new information about the licensee, and the data of the document confirming the fact of making the appropriate changes in the Unified State Register of Legal Entities;
  3. In case if the licensee intends to carry out the licensed activity at a new address of performing works and rendering services and (or) intends to perform new works and render new services that constitute the licensed activity not specified in the license, the licensee shall specify an address and (or) the works, which the licensee intends to perform, in the re-licensing application, and shall also submit the following information confirming the licensee’s compliance with the licensing requirements:
    • Information that the licensee has the right of ownership or other legal basis for the use of the facilities, buildings, constructions and other objects, instrumentalities, equipment and technical documentation complying with the established requirements, as well as the use of manufacturing specifications needed for manufacture of drugs for medical use at the specified new address and (or) to perform the new works;
    • Information about of employment of workers that have concluded employment contracts and have corresponding higher or secondary vocational education, who are responsible for manufacture and labeling of drugs and intend to carry out activities at the specified new address or to perform new works.
  4. In case of termination of activities at one or several addresses of locations of performing such activities specified in the license, the re-licensing application shall specify the addresses at which the activities are terminated and the date on which they are actually terminated.

In case of reorganization of legal entities in the form of merger, re-licensing is permitted only on condition that each of the legal entity participating in the merger is licensed to the same type of activity at the date of the state registration of the successor of the reorganized legal entities.

3. To obtain a duplicate of the license, the licensee shall submit an application and details of a document confirming the payment of the state fee for granting the license, or other information confirming the payment of a specified state fee for granting of such duplicate. In case of damage of the license, the application for granting of the duplicate shall be accompanied with the damaged license sheet.

4. To obtain a copy of the license, the licensee shall submit an application to the Ministry of Industry and Trade of Russia.

5. For premature termination of the license, the licensee shall submit an application for termination of the performed licensed activity within fifteen working days before the date of the actual termination of the licensed activity.

6. In case if the license application, the re-licensing application, the application for the termination of the license, the application for a duplicate license or a copy of the license contains information on the need of providing it in the form of an electronic document, the Ministry of Industry and Trade of Russia shall send the license, a duplicate of the license or a copy of the license to the applicant in the form of an electronic document with the electronic signature.

  • Payment details

    • Granting of a license — 7,500 rubles
    • Re-licensing, due to addition of any information on the addresses of locations of the licensed activity, on the works performed and the services rendered as part of the licensed activity — 3,500 rubles
    • For re-licensing or issuing a duplicate of the license, the state fee of 750 rubles shall be paid
    • The state fee for issuing a duplicate of the license — 750 rubles

    State fee for granting the license:

    • Account — 40101810500000001901;
    • Beneficiary’s bank — Operations Department-1 of Bank of Russia;
    • BIC — 044501002;
    • Beneficiary — Transregional FTD (Ministry of Industry and Trade of the Russian Federation), INN  (Taxpayer identification number)— 7705596339, KPP  (Tax registration reason code) — 770501001.

    The WBS code of the administered income shall be specified in the box 104 of the payment order:

    • 020 108 07081 01 0300 110 — when granting of license;
    • 020 108 07081 01 0400 110 — when re-licensing (change of manufacture addresses, list of works);
    • 020 108 07081 01 0500 110 — when re-licensing (change of the organization identification, legal entity address, legal entity reconstruction);
    • 020 108 07081 01 0700 110 — when granting a duplicate of the license;
    • GAC code 45381000 shall be specified in the box 105 of the payment order.

    The title of the payment directed as the federal budget income shall be specified in the destination box.

    The Department of Pharmaceutical and Medical Industry coordinates the procedure of rendering the public service in the Ministry of Industry and Trade of Russia.



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Address: c. Moscow, 2-й Syromyatnicheskiy str., д.1
Phone: +7(495)665-81-35
Address: г. Kazan, Pr. Yamasheva 46/33
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