Article 21. Issuance of a permit for the handling of pathogenic biological agents and its appendices Code on the Health of the People and the Healthcare System of the Republic of Kazakhstan

     The footnote. Title of Article 21 as amended by the Law of the Republic of Kazakhstan dated 05/21/2022 No. 123-VII (effective six months after the date of its first official publication).

     1. The state body in the field of sanitary and epidemiological welfare of the population shall issue a permit for the handling of pathogenic biological agents and its attachment to microbiological laboratories, regardless of their forms of ownership, based on the conclusion of the commission for monitoring compliance with requirements in the field of biological safety (regime commission).

     2. The regulations on the commission for monitoring compliance with requirements in the field of biological safety (regime commission) and its composition are approved by the state body in the field of sanitary and epidemiological welfare of the population.

     3. For carrying out research, experimental, industrial, field and diagnostic work with pathogenic biological agents, subject to laboratory containment measures, including engineering, operational and technical requirements (laboratory biosafety level), a permit is issued for the handling of pathogenic biological agents and its annex, depending on the risk group used in the work. pathogenic biological agents.

     For each facility (stationary or mobile) where activities for the management of pathogenic biological agents will be carried out, a permit for the management of pathogenic biological agents and an annex to it are issued, taking into account the group of pathogenicity and the degree of danger, indicating the names of pathogenic biological agents.

     4. The basis for issuing a permit for the handling of pathogenic biological agents and its appendices is the compliance of the activities of the entity handling pathogenic biological agents with the qualification requirements for this activity.

     5. The grounds for refusal to issue a permit for the handling of pathogenic biological agents and its appendices are:

     1) failure to submit or provide false documents and information necessary to obtain permission to handle pathogenic biological agents and its appendices;

     2) the absence of a sanitary and epidemiological conclusion on an object of high epidemic significance;

     3) a negative conclusion of the commission for monitoring compliance with requirements in the field of biological safety (regime commission) on the basis of non-compliance with the qualification requirements for handling pathogenic biological agents.

     6. The grounds for revoking a permit for handling pathogenic biological agents and its appendices are:

     1) failure to eliminate, within the prescribed period, the violation that was the basis for suspending the permit for handling pathogenic biological agents and its appendices;

     2) repeated detection within the last twelve calendar months of a violation having a dangerous effect on the health of humans, animals, plants and the environment, which served as the basis for suspending the permit for the handling of pathogenic biological agents and its appendices;

     3) other cases stipulated by the laws of the Republic of Kazakhstan.

     The revocation or suspension of the permit for handling pathogenic biological agents and its appendices is carried out in accordance with the Code of the Republic of Kazakhstan on Administrative Offenses.

     7. The grounds for termination of the permit for handling pathogenic biological agents and its appendices are:

     1) revocation of permission to handle pathogenic biological agents and its appendices;

     2) cancellation of the permissive procedure;

     3) termination of activity, liquidation of a legal entity;

     4) the applicant's voluntary request for termination of the permit for handling pathogenic biological agents and its appendices;

     5) other cases stipulated by the laws of the Republic of Kazakhstan.

     From the moment of termination of the permit for the treatment of pathogenic biological agents and its annex, it is not allowed to carry out activities for the treatment of pathogenic biological agents.

     The footnote. Article 21 as amended by the Law of the Republic of Kazakhstan dated 05/21/2022 No. 123-VII (effective six months after the date of its first official publication).

President    

Republic of Kazakhstan     

© 2012. RSE na PHB "Institute of Legislation and Legal Information of the Republic of Kazakhstan" of the Ministry of Justice of the Republic of Kazakhstan  

 Constitution Law Code Standard Decree Order Decision Resolution Lawyer Almaty Lawyer Legal service Legal advice Civil Criminal Administrative cases Disputes Defense Arbitration Law Company Kazakhstan Law Firm Court Cases