Medicines

Counter of citizens' requests

Licensing of pharmaceutical activity

In accordance with the Federal Law dated November 21, 2011 № 323-FZ “On Fundamentals of Healthcare Protection of the Citizens of the Russian Federation” and with the Resolution of the Government of the Russian Federation dated November 21, 2011 № 957 “On Organization of Licensing of Certain Types of Activity” the Federal Service for Surveillance in Healthcareconducts licensing of pharmaceutical activity:

Roszdravnadzor (Division for licensing and control over observance of mandatory requirements, Department of licensing of pharmaceutical activity and activities on circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants and control over circulation of medicines) performs licensing of pharmaceutical activity by organizations involved  into wholesale of medicines for medical use.

Regional authorities of Roszdravnadzor in the constituent entities of the Russian Federation perform licensing of pharmaceutical activity by pharmaceutical institutions subordinate to federal executive bodies and to national academies of science.

The results of provision of the state service of licensing are:

- issue (refusal to issue) of a license;

- re-licensing (refusal of re-licensing);

- issue of a duplicate of a license, copy of a license;

- decision on suppression of a license, renewal of a license, termination of a  license and cancellation of a license;

- applicant’s provision of  extracts from the Unified Register of Licenses.

Applications and documents (copies of documents) for issuing of a license or for re-licensing can be submitted by a license applicant (licensee) in  a form of electronic document via  information and communication technologies including the Unified Portal of State and Municipal Services: www.gosuslugi.ru.

Main functions:

- Provision of the state service of licensing of pharmaceutical activity

- The service is provided in accordance with the Federal Law dated May 05, 2011 № 99-FZ “On Licensing of Certain Types of Activity” and the Federal Law dated  July 27, 2010 № 210-FZ “On Organization of Provision with State and Municipal Services”. 

- License supervision of pharmaceutical activity. Control of observance of requirements for licensing is performed in accordance with the schedule of inspections agreed with the Office of the Attorney General of the Russian Federation in compliance with the provisions of the Federal Law dated December 26, 2008 № 294-FZ “On Protection of the Rights of Legal Entities and Individual Entrepreneurs in the Process of State Control (Surveillance) and Municipal Supervision”.

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To download forms of the documents used in the process of licensing and bank details required to effect payment of the state duty click here.

Description of the state service “Licensing of pharmaceutical activity”

I. Licensing

Documents submitted by an applicant personally:

1. Application.

2. Notarized copies of constituent documents.

3. Copies of documents confirming that an applicant owns or legally possesses all equipment and premises necessary, for conducting pharmaceutical    activity and compliant with the established requirements and the rights thereto are not registered in the Unified State Register of Real Property Rights and Transactions Therewith.

4. Copies of documents confirming higher or secondary pharmaceutical education and certificates of a specialist.

5. Copies of documents or duly notarized extracts from documents confirming that the head of an institution has required professional experience.

Information/documents, received by Roszdravnadzor via the electronic system of interagency cooperation*:

1.Information  /documents about an  applicant from in the Unified Register of Legal Entities (state registration number of an incorporation note, data of a document confirming introduction of information about a legal entity into the state register of legal entities);

tax ID number and data on registration of an applicant with a tax authority); tax ID number and data on registration of an applicant with a tax authority) (Federal Tax Service of Russia).

2. Information / documents confirming that an applicant owns or legally possesses all equipment and premises necessary, for conducting pharmaceutical    activity, which are compliant with the established requirements and the rights thereto  are not registered in the Unified State Register of Real Property Rights and Transactions Therewith.

3.Information/documents confirming that an applicant holds a duly issued sanitary and epidemiological finding of compliance of premises with sanitary requirements, are provided by the Register of Sanitary and Epidemiological findings of compliance (Non-compliance) of Types of Activities (operations, services) with the Sanitary Requirements (Rospotrebnadzor).

4. Information/documents, confirming the payment of duty for licensing (Russian Federal Treasury).

* Documents submitted on applicant’s own initiative

Service period

45 (forty five) working days from the date of the receipt   of a  duly completed application  for  the license and a set of documents by the licensing authority

State duty

licensing – 7500 rubles

 

II. Re-licensing (due to  reorganization (transformation) of a legal entity, change of its name, address or location)

Documents submitted by an applicant personally:

1. Application.

2. Original valid license.

Service period

10 (ten) working days from the date of the receipt of a  duly completed application for re-licensing and all necessary documents by a licensing authority

State duty

re-licensing  - 750 rubles

 

III. Re-licensing (due to change of address where a legal entity carries out activity subject to licensing or to changes in the  list of  activities and services provided that are subject to licensing)

Documents submitted by an applicant personally:

1. Application.

2. Original of the current license.

3. Copies of the documents confirming that an applicant owns or legally possesses all equipment and premises necessary, for conducting pharmaceutical    activity, and which are compliant with the established requirements and the rights thereto are not registered in the Unified State Register of Real Property Rights and Transactions Therewith.(if an applicant intends to conduct an activity subject to licensing at address, which is not specified in a license).

Information/documents, received by Roszdravnadzor via the electronic system of interagency cooperation *:

1. Information/documents confirming that an applicant owns or legally possesses all equipment and premises necessary for conducting pharmaceutical    activity, which are compliant with the established requirements and the rights thereto  are not registered in the Unified State Register of Real Property Rights and Transactions Therewith.(Rosreestr)(if an applicant intends to conduct an activity subject to licensing at address, which is not specified in a license).

2. Information/documents confirming that an applicant possesses a duly issued sanitary and epidemiological finding of compliance of premises with sanitary requirements are provided by the Register of Sanitary and Epidemiological Findings of Compliance (Non-compliance) of Types of Activities (operations, services) with the Sanitary Requirements (Rospotrebnadzor).

3. Information or a document, confirming payment of the state duty for re-licensing (Russian Federal Treasury).

* Documents submitted on applicant’s own initiative

Service period

30 (thirty) working days from the date of receipt of  duly completed application for re-licensing and all necessary documents by a licensing authority

State duty

re-licensing - 3500 rubles

 

IV. Issue of a duplicate of a license (if lost  or damaged), copy of a license

Documents submitted by an applicant personally:

An application.

Information/documents, received by Roszdravnadzor via the electronic system of interagency cooperation *:

Information or a document confirming payment of a duty for re-licensing (Russian Federal Treasury).

* Documents submitted on applicant’s own initiative

Service period

3 (three) working days from the date of receipt of an application for a duplicate of a license with a copy of a damaged license (if applicable)

State duty

issue of a duplicate of a license – 750 rubles

 

V. Provision of information from the Unified Register of Licenses 

Documents submitted by an applicant personally:

An application.

Service period

5 (five) working days from the date of receipt of an application for provision of such data

State duty

free of charge

 

Institutions for documents submission, working hours, contacts, responsible officers

Information on the procedure of provision of the state service is provided at:

4, bld.1 Slavyanskaya Square, Moscow, 109074,

room 210 (access control office).

Working hours:

Monday - Thursday:

from 9-00 am to 6-00 pm;

Friday: from 9-00 am to  4:45 pm;

Lunch break: form 1-00 pm to 1:45 pm

Telephones:

+7(499) 578-01-43;

+7(499) 578-01-44;

fax: +7(495) 698-31-18

E-mail: info@roszdravnadzor.ru

Call center:

+7(495) 698-16-14;

+7(495) 698-45-38.

Guskova Irina  -  Deputy Head of Division .

Tel.: +7(499) 578-01-43

e-mail: guskovaia@roszdravnadzor.ru

Gurancheeva Svetlana –  Deputy Head of the Department of licensing of activity on circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants

Tel.: +7(499) 578-01-44

e-mail: GurancheevaSV@roszdravnadzor.ru

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