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Appendix P
Regulation of the Russian Government on Licensing Activities Connected with the Use of Infectious Disease Antidotes, No. 7311

Approved
by a resolution of the Government
of the Russian Federation
July 4, 2002, No. 501

STATUTE ON LICENSING OF ACTIVITIES ASSOCIATED WITH PATHOGENIC AGENTS OF INFECTIOUS DISEASES

(Resolution of the Russian Government, as revised October 3, 2002, No. 731)

  1. This statute defines the protocol for the licensing of activities associated with pathogenic agents of infectious diseases by legal entities or individual entrepreneurs.

  2. Activities associated with the use of agents of infectious diseases, including those common to humans and animals are subject to state licensing. These include microorganisms, including genetically modified ones, bacterial toxins, protozoans, helminths and biological poisons of pathogenicity groups I – IV, their industrial and archival strains, sanitary-indicative microorganisms, and materials contaminated or suspected to be contaminated with infectious disease agents of pathogenicity groups I – IV.

1  

Translated from the Russian by Supernova Translations.com.



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OCR for page 133
Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security Appendix P Regulation of the Russian Government on Licensing Activities Connected with the Use of Infectious Disease Antidotes, No. 7311 Approved by a resolution of the Government of the Russian Federation July 4, 2002, No. 501 STATUTE ON LICENSING OF ACTIVITIES ASSOCIATED WITH PATHOGENIC AGENTS OF INFECTIOUS DISEASES (Resolution of the Russian Government, as revised October 3, 2002, No. 731) This statute defines the protocol for the licensing of activities associated with pathogenic agents of infectious diseases by legal entities or individual entrepreneurs. Activities associated with the use of agents of infectious diseases, including those common to humans and animals are subject to state licensing. These include microorganisms, including genetically modified ones, bacterial toxins, protozoans, helminths and biological poisons of pathogenicity groups I – IV, their industrial and archival strains, sanitary-indicative microorganisms, and materials contaminated or suspected to be contaminated with infectious disease agents of pathogenicity groups I – IV. 1   Translated from the Russian by Supernova Translations.com.

OCR for page 133
Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security 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;

OCR for page 133
Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security A copy of a legally-issued certificate confirming compliance with sanitary and epidemiological norms and rules. Documents submitted in order to obtain a license are accepted with reference to an inventory list, a copy of which, with an indication of date of acceptance, is forwarded by the licensing authority to the applicant. Copies of non-notarized documents are accepted upon presentation of the originals. It is unacceptable to require the license applicant to submit documents not specified in this statute. Submission of untrue, inaccurate, obsolete, or incomplete information by the license applicant is punishable under the laws of the Russian Federation. Licenses for activities associated with use of infectious diseases agents are issued for a five-year term. The licensing authority makes its determination on granting or refusing the license request within 60 days after the date when the request, along with all necessary documents, was received. If the license is lost, the licensee has the right to obtain a duplicate thereof. If the licensee has territorially autonomous subsidiaries and facilities to be used for activities subject to licensing, certified copies of the license corresponding to the number of such subsidiaries and facilities will be issued by the licensing authority in addition to the original license. Within five days after its determination of approval, extension, re-licensing, suspension, or nullification of the license, the licensing authority must provide written notification to the licensee, the appropriate tax authorities, and the State Sanitary and Epidemiological Surveillance Center. Within fifteen days after any change of domicile or location of territorially autonomous subsidiaries and facilities to be used for activities subject to licensing, the licensee must notify the licensing authority in writing. The licensing authority maintains a register of licenses, in which the following is indicated: Name of the licensing authority; Activities subject to licensing; Information regarding the licensee: For a legal entity: name, form of organizational and legal ownership and location of the legal entity, as well as locations of its territorially

OCR for page 133
Biological Science and Biotechnology in Russia: Controlling Diseases and Enhancing Security 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, as well as location of business for activities subject to licensing; Licensee code identifier (according to the Russian National Registry of Enterprises and Organizations) and taxpayer identification number; Date of license approval decision; License number; Term of license validity; Information regarding registration of the license in the license register; Information regarding extension of the term of license validity; Information regarding re-licensing; Grounds for and dates of suspension and renewal of the license; Grounds for and date of nullification the license. Through scheduled and unscheduled inspections, the licensing authority oversees, within the bounds of its expertise, the licensee’s compliance with license requirements and conditions. Scheduled inspections are conducted no more than once every two years. Unscheduled inspections are conducted to verify that the licensee has corrected violations discovered during a scheduled inspection, or in the event that the licensing authority should receive from a state authority, legal entity, or private individual any information (confirmed by documents and other proof) regarding violation by the licensee of license requirements and conditions. The licensing authority shall notify the licensee of an upcoming inspection ten days prior to its commencement. The licensee must provide conditions for the licensing authority to conduct its inspections, including by providing information and documentation. The duration of an inspection must not exceed one month. Inspections are conducted on the basis of the licensing authority’s order, which specifies the licensee, time frame for inspection, and members of the inspection team. Inspection results are documented in an inspection report (in duplicate), which spells out specific violations and deadlines by which they must be corrected. One copy of the report is given to the licensee against his signature. The licensee notifies the licensing authority in writing of correction of the violations by the deadline specified in the inspection report. When conducting its licensing activity, the licensing authority operates in compliance with the Federal Law on Licensing of Selected Types of Activities. SOURCE: Russian Federation (2002).