Medicines

Counter of citizens' requests

Licensing of activity on circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants

In accordance with the Federal Law dated November 21, 2011 № 323-FZ “On Fundamentals of Healthcare Protection of the Citizens in the Russian Federation” and the Resolution of the Government of the Russian Federation dated November 21, 2011 № 957 “On Organization of Licensing of Certain Types of Activities” the Federal Service for Surveillance in Healthcareperforms licensing of circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants.

Roszdravnadzor (Division for licensing and supervision over observation of mandatory requirements, department for licensing of pharmaceutical activity and activity on circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants and control over circulation of medicines) performs licensing of activity on circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants as to: 

- circulation of narcotic drugs and psychotropic substances set out in the lists I,II,III of the register carried out by organizations engaged into wholesale of medicines;

- circulation of precursors of narcotic drugs and psychotropic substances set out in the list I of the register;

- circulation of precursors of narcotic drugs and psychotropic substances set out in the table I of the list IV of the register carried out by organizations manufacturing medicines;

- cultivation of drug-containing plants.

Territorial bodies of Roszdravnadzor in the constituent entities of the Russian Federation perform licensing of activity on circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plant as to:

- circulation of narcotic drugs and psychotropic substances set out in the lists I, II,III of the register carried out by pharmacy institutions subordinate to federal executive bodies, national academies of science;

- circulation of precursors of narcotic drugs and psychotropic substances set out in the table I of the list IV of the register (except for organizations manufacturing medicines).

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

- issue (refusal in issue) of a license;

- re-licensing (refusal in 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 license;

- provision of extracts from the Unified Register of Licenses to applicants.

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

Main tasks/Activities/Primary objectives:

- Provision of state service for licensing of activity on circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants.

- The state service is provided in accordance with the Federal Law dated May 4, 2011 № 99-FZ “Оn Licensing of Certain Types of Activity” and the Federal Law dated July 27, 2010 № 210-FZ “On Organization of Provision of State and Municipal Services”

- Supervision over licensing of circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants. Control over observance of licensing requirements 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 circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants”

I. Issue of a license

Documents submitted by an applicant personally:

1. Application

2. Notarized copies of the constituent documents.

3.Copies of documents confirming that an applicant owns or legally possesses premises or land property which comply  with the set requirements and are required for circulation of narcotic drugs, psychotropic substances and their precursors, as well as cultivation of drug-containing plants, and there is no record of rights thereto in the Unified State Register of Real Property Rights and Transactions Therewith 

4. Copies of documents confirming that an applicant owns or legally possesses equipment which complies with the set requirements and is required for circulation of narcotic drugs, psychotropic substances and their precursors, cultivation of drug-containing plants.

5. A copy of the professional certificate confirming that a legal entity or a head of a legal entity department has appropriate professional  qualification for conducting the circulation of narcotic drugs and psychotropic substances included into the lists I-III of the register, precursors included into the list I of the register and for cultivation of drug-containing plants.

6. Copies of academic credentials issued to persons performing circulation of narcotic drugs and psychotropic substances included into the lists I-III of the register, precursors included into the list I of the register as well as of certificates of qualification of pharmaceutical and medical workers.

7. Copies of medical certificates duly issued by state or municipal institutions confirming that workers who when performing their professional duties have access to narcotic drugs, psychotropic substances and their precursors set out in the list I and table I of the register, or to cultivated drug-containing plants, do not have drug addiction, toxicomania, or chronic alcoholism.

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

1. Information/documents about an applicant from the Unified Register of Legal Entities (state registration number of a note on creation of a legal entity, document data confirming the fact of introduction of data on an applicant to the Unified State Register of Legal Entities; tax ID and data of a document confirming applicant’s registration with a tax authority); tax ID and data of a document confirming  applicant’s registration with a tax authority) (Federal Tax Service of Russia).

2. Copies of documents confirming that an applicant owns or legally possesses premises or land property which comply  with the set requirements and are required for carrying out activity on circulation of narcotic drugs, psychotropic substances and their precursors, as well as cultivation of drug-containing plants, and there is no  record of rights thereto in the Unified State Register of Real Property Rights and Transactions Therewith (Rosreestr – Federal Service for State Registration, Cadaster and Cartography).

3. Information/documents confirming availability of the following certifications   issued by the authority for control over circulation of narcotic drugs and psychotropic substances: (Federal Drug Control Service of Russia):

a) of compliance of sites and premises where activity related to circulation of narcotic drugs, psychotropic substances and precursors included into the list I, and (or) cultivation of drug-containing plants are carried out, with   the requirements for equipment of such objects and premises with technical security tools;

b) certificates confirming that workers, who in course of their professional duties have access to narcotic drugs, psychotropic substances included into the list I, precursors or cultivated drug-containing plants, do not have outstanding or unexpunged convictions for commission of crimes of medium gravity or grave or especially grave crimes or crimes involving illegal trafficking of narcotic drugs and psychotropic substances, their precursors or illegal cultivation of drug-containing plants, including crimes committed outside the territory of the Russian Federation;

c) certificates confirming that workers, who in course of their professional duties will have a direct access to precursors included in the table I of the list IV of the register, do not have  outstanding or unexpunged convictions for commission crimes of medium gravity or grave or especially grave crimes or crimes involving illegal trafficking of narcotic drugs and psychotropic substances, their precursors or illegal cultivation of drug-containing plants, including crimes committed outside the territory of the Russian Federation.

4. Information/documents, confirming payment of the state duty for issue of a license (Russian Federal Treasury).

* Documents submitted on applicant’s own initiative

Service period

45 (forty five) working days from the date of receipt of an application for a license accompanied with all other necessary documents

State duty

issue of a license – 7500 rubles

 

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

Documents submitted by an applicant:

1. Application.

2. Original of a current license.

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

1. Information or a document about an applicant or his/her legal representative, as stipulated in Article 13, paragraph 1 of  the Federal Law FZ №99 dated May 4, 2011, details of a document confirming appropriate amendments into the Unified State Register of Legal Entities (Federal Tax Service of Russia).

2. Information/documents, confirming payment of the state duty for issue of a license (Russian Federal Treasury).

* Documents submitted on applicant’s own initiative

Service period

10 (ten) working days form the date of the receipt by a licensing authority  a duly completed application for re-licensing with a full set of documents

State duty

re-licensing - 750 rubles

 

III. Re-licensing (due to change of addresses of locations where a  licensed activity is performed by a  legal entity, or to changes in the list of operations and services provided, which  are licensed activities)

Documents submitted by an applicant personally:

1. An application.

2. Original of a current license.

3. Copies of documents confirming that an applicant owns or legally possesses premises or land property which comply  with the set requirements and are required for carrying out activity on circulation of narcotic drugs, psychotropic substances and their precursors, as well as cultivation of drug-containing plants, and there is no a record of rights thereto 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; if an applicant intends to perform operations (to provide with the service of cultivating drug-containing plants) which has not previously been specified in a license).

4. Copies of documents confirming that an applicant owns or legally possesses equipment which complies  with the set requirements and is required for carrying out activity on circulation of narcotic drugs, psychotropic substances and their precursors, as well as cultivation of drug-containing plants (if an applicant intends to conduct an activity subject to licensing at address, which is not specified in a license; if an applicant intends to perform operations (to provide with the service of cultivating drug-containing plants) which has not previously been specified in a license).

Data/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 – Federal Service for State Registration, Cadaster and Cartography) (if an applicant intends to conduct an activity subject to licensing at address, which is not specified in a license) (if an applicant intends to perform operations (to provide with the service of cultivating drug-containing plants) which has not previously been specified in a license.

2. Information/ documents confirming availability of a certificate of compliance of sites and premises where operations related to circulation of narcotic drugs, psychotropic substances and precursors included into the list I and (or) cultivation of drug-containing plants are carried out, with   the requirements for equipment of such sites and premises with technical security equipment (Federal Drug Control Service of Russia) (if an applicant intends to conduct an activity subject to licensing at address, which is not specified in a license) (if an applicant intends to perform operations (to provide with the service of cultivating drug-containing plants) which has not previously been specified in a license).

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 by a licensing authority a duly completed application with a full set of necessary documents 

State duty

re-licensing - 3500 rubles

 

IV. Issuing a duplicate license (due to loss or damage of a license), copy of a license

Documents submitted by an applicant personally:

An application.

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

Information/documents confirming payment of the state 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 license with a damaged license attached (in a case of damage of a license)

State duty

issue of a duplicate license – 750 rubles

 

V. Provision of data 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 requesting such information

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, office 210, Slavyanskaya Square, Moscow, 109074 (access control office).

Working hours:

Monday - Thursday:

from 9:00 am to 6:00 pm;

Friday: from 9 am to 4:45 pm;

Lunch break: from 1:00 pm to 1:45 pm.

Telephone:

+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 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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