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, 109012 (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
