Licensing of activities associated with pathogenic infectious disease agents is conducted by the Ministry of Health of the Russian Federation, hereinafter referred to as the “licensing authority.”
Licensing requirements and conditions for engaging in activities associated with pathogenic infectious disease agents are as follows:
The license applicant or licensee must possess production facilities compliant with norms and rules established by the state and belonging to him on terms of ownership or any other legal terms (and in case of operations with infectious disease agents of pathogenicity groups I – II, the facilities must be equipped with protective devices and an alarm system), as well as equipment, instruments, and anything else necessary to conduct the activities subject to licensing;
Sanitary and epidemiological norms and rules established by the state for operations with infectious disease agents of pathogenicity groups I – IV must be observed;
Employees of legal entities and individual entrepreneurs alike must possess education or specialized vocational training in accordance with the requirements and nature of their jobs.
To obtain a license, applicants must submit the following documents to the licensing authority:
License request, which includes:
For a legal entity: name, form of organizational and legal ownership, and location, as well as locations of its territorially-autonomous subsidiaries and facilities to be used for activities subject to licensing;
For an individual entrepreneur: last name, first name, patronymic, place of residence, personal identification information, and location of business;
A description of activities subject to licensing that the legal entity or individual entrepreneur in question intends to conduct;
Copies of articles of association and of documents certifying that the legal entity is listed in the Unified Legal Entity Register.
(Resolution of the Russian Government, as revised October 3, 2002, No. 731) (See previous version of the text)
A copy of the state registration certificate of the license applicant as an individual entrepreneur;
A copy of the license applicant’s tax registration certificate;
Document confirming payment of fees for the licensing authority’s review of the applicant’s license request;
Copies of documents confirming the expertise of the individual entrepreneur and employees of the legal entity;