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, 109012,
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
