Article 15. Implementation of activities related to the management of pathogenic biological agents of the Law on Biological Safety of the Republic of Kazakhstan

Home / RLA / Article 15. Implementation of activities related to the management of pathogenic biological agents of the Law on Biological Safety of the Republic of Kazakhstan

1. The process of handling pathogenic biological agents includes their detection, carried out by selecting and examining substances and materials, including from individual components of the natural environment, vectors and carriers of particularly dangerous infectious and (or) parasitic diseases (including their waste products), which may contain pathogenic biological agents (potentially dangerous biological substances).

2. Entities handling pathogenic biological agents are required to:

1) obtain a permit for handling pathogenic biological agents and its attachment;

2) comply with requirements in the field of biological safety;

3) undergo the accreditation procedure in the field of conformity assessment in accordance with the procedure established by the legislation of the Republic of Kazakhstan on accreditation in the field of conformity assessment;

4) comply with the requirements of the legislation of the Republic of Kazakhstan when working with restricted access information;

5) provide statistical information and other accounting and reporting documentation (information) in the field of biological safety in accordance with the rules of accounting, monitoring and forecasting (modeling) in the field of biological safety;

6) organize and carry out measures to ensure the biological protection of potentially dangerous biological objects, taking into account the level of biological risks in accordance with the rules for ensuring biological protection;

7) to monitor the safe handling of pathogenic biological agents at all stages of their handling;

8) to assist the authorized body in the field of biological safety, the state bodies specified in Article 10 of this Law, in matters of ensuring biological safety;

9) immediately inform the territorial divisions of the state body in the field of sanitary and epidemiological welfare of the population, authorized bodies in the field of veterinary medicine, plant protection, plant quarantine, territorial bodies of the authorized body in the field of civil protection, authorized body in the field of science about the facts of accidents (emergencies), infection of workers with infectious diseases in the process of handling pathogenic biological agents;

10) organize, in accordance with the legislation of the Republic of Kazakhstan, periodic medical examinations and examinations, training, knowledge testing on biological safety and labor protection for managers, specialists and support staff;

11) comply with the requirements of the legislation of the Republic of Kazakhstan in the field of control of specific goods during import, export, re-export or transit through the territory of the Republic of Kazakhstan of pathogenic biological agents subject to control of specific goods.

3. Entities handling pathogenic biological agents of pathogenicity groups I and (or) II, in addition to the duties provided for in paragraph 2 of this Article, must:

1) ensure the availability of trained specialists who handle pathogenic biological agents of pathogenicity groups I and (or) II;

2) provide a regime of restricted access to potentially dangerous biological objects in accordance with the legislation of the Republic of Kazakhstan;

3) in accordance with the procedure defined by the rules of accounting, monitoring and forecasting (modeling) in the field of biological safety:

integrate information systems used in the implementation of activities with the state information system in the field of biological safety;

provide information about specialists who handle pathogenic biological agents of pathogenicity groups I and (or) II to the state body in the field of sanitary and epidemiological welfare of the population, authorized bodies in the field of veterinary medicine, science for inclusion in the relevant register.

4. Based on the conclusion of the commission for monitoring compliance with requirements in the field of biological safety (regime commission), in accordance with the Code of the Republic of Kazakhstan "On Public Health and the Healthcare System" and the Law of the Republic of Kazakhstan "On Permits and Notifications", the state body in the field of sanitary and epidemiological welfare of the population issues a permit for the treatment of pathogenic biological agents. and an appendix to it.

5. The management of pathogenic biological agents causing particularly dangerous infectious diseases is carried out by state-owned enterprises and state institutions, as well as other legal entities, one hundred percent of the voting shares (participation shares in the authorized capital) of which belong to the national holding company.

6. Reference research in the field of biological safety is carried out:

1) in diagnostically difficult and expert cases;

2) in order to identify pathogenic biological agents, including conducting research in particularly difficult cases;

3) in order to study newly identified pathogenic biological agents;

4) to issue an expert opinion in doubtful or controversial cases.

7. Reference (reference) research in the field of biological safety is carried out by organizations authorized for this activity, in accordance with the rules for the implementation and admission to the implementation of reference (reference) research.

8. Subjects conducting reference research in the field of biological safety must comply with national standards and carry out organizational and methodological work on the implementation and functioning of an external quality assessment system, as well as an external assessment of the quality of activities related to the management of pathogenic biological agents.

The Law of the Republic of Kazakhstan dated May 21, 2022 No. 122-VII SAM.

This Law defines the legal basis of state regulation in the field of biological safety of the Republic of Kazakhstan and is aimed at preventing biological threats.

President

Republic of Kazakhstan

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