of November 28, 2022 No. 393
About approval of Rules of implementation and the admission to implementation reference (referens-) researches
According to the subitem 11) Item 3 of article 10 of the Law of the Republic of Kazakhstan "About biological safety of the Republic of Kazakhstan" PRIKAZYVAYU:
1. Approve the enclosed Rules of implementation and the admission to implementation reference (referens-) researches.
2. To provide to committee of the state inspection in agro-industrial complex of the Ministry of Agriculture of the Republic of Kazakhstan in the procedure established by the legislation:
1) the state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;
2) placement of this order on Internet resource of the Ministry of Agriculture of the Republic of Kazakhstan after its official publication.
3. To impose control of execution of this order on the supervising vice-Minister of Agriculture of the Republic of Kazakhstan.
4. This order becomes effective after ten calendar days after day of its first official publication.
Acting minister of agricultural industry of the Republic of Kazakhstan
A. Saparov
It is approved Ministry of Health of the Republic of Kazakhstan |
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Approved by the Order of the deputy. The Minister of Agriculture of the Republic of Kazakhstan of November 28, 2022 No. 393
1. These rules of implementation and the admission to implementation reference (referens-) researches (further – Rules) are developed according to the subitem 11) of Item 3 of article 10 of the Law of the Republic of Kazakhstan "About biological safety of the Republic of Kazakhstan" (further – the Law) and determine procedure and the admission to implementation reference (referens-) researches.
2. In these rules the following basic concepts are used:
1) the organization – the legal entity allowed to implementation reference (referens-) researches in the field of biological safety according to these rules;
2) authorized body on plant quarantine (further – authorized body) – the central executive body performing management and cross-industry coordination in the field of plant quarantine.
3. According to Item 6 of article 15 of the Law reference (referens-) researches in the field of biological safety are performed:
1) in diagnostic complex and expert cases;
2) for the purpose of identification of pathogenic biological agents, including carrying out researches in particularly complex cases;
3) for the purpose of studying of again revealed pathogenic biological agents;
4) for issue of the expert opinion in case of doubtful or disputable cases.
4. According to Item 7 of article 15 of the Law reference (referens-) researches in the field of biological safety are performed by the organizations allowed to these activities according to these rules.
5. In case of the admission to implementation reference (referens-) researches in the field of biological safety the organization performs:
1) organizational and methodical work on implementation and functioning of system of external quality evaluation, namely:
participation in preparation of projects of organizational, methodical managements and instructions, information letters and research opinions concerning measurements of referensny sizes in the field of biological safety;
participation in development of the regulating and methodical documents regulating organization activity on performing laboratory diagnostics and external quality evaluation of laboratory researches in the field of biological safety;
implementation of techniques reference (referens-) researches in the field of biological safety;
implementation of standard laboratory procedures of researches;
participation in research of the new or already existing techniques and (or) measurements concerning their validity;
studying, development and deployment of modern methods and standards of laboratory researches, diagnostic algorithms, use of results of external quality evaluation for rejection of methods, the equipment, technologies in the field of biological safety;
2) implementation of external quality evaluation of activities for the address with pathogenic biological agents, namely:
carrying out validation and assessment of comparability of the different analytical methods applied to laboratory diagnostics of different analyses in the field of biological safety;
implementation of expert laboratory researches in the field of biological safety in case of disputable and complex cases of laboratory diagnostics (arbitral researches);
rendering the advisory and methodical and organizational help to the organizations in enhancement of their activities by standardization of engineering procedures, carrying out estimates of the control samples represented by producers, estimates of correctness of carrying out in laboratory control of quality and reliability of the conducted laboratory researches in the field of biological safety;
participation in the international programs of external quality evaluation, the international projects and scientific programs in the field of biological safety.
6. Appellate procedure of results reference (referens-) the researches conducted by the organizations is carried out according to the Administrative procedural Procedure Code of the Republic of Kazakhstan.
7. The authorized body places on official Internet resource of authorized body the announcement of order taking for receipt of the admission to implementation reference (referens-) researches in the field of biological safety (further – the announcement) within 30 (thirty) working days prior to order taking.
In the announcement the following information is specified:
1) date and time of the beginning and completion of order taking;
2) the commitment form according to appendix 1 to these rules.
The term of final date of submission of requests by the organizations constitutes 7 (seven) working days from the date of placement of the announcement.
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