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ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of November 25, 2022 No. 953

About approval of Rules of forming, maintaining and content of national collections of pathogenic and industrial microorganisms and the list of the organizations authorized on their forming, maintaining and content

According to the subitem 2) of article 8 of the Law of the Republic of Kazakhstan "About biological safety of the Republic of Kazakhstan" the Government of the Republic of Kazakhstan DECIDES:

1. Approve enclosed:

1) Rules of forming, maintaining and content of national collections of pathogenic and industrial microorganisms;

2) the list of the organizations authorized on forming, maintaining and content of national collections of pathogenic and industrial microorganisms.

2. This resolution becomes effective since November 24, 2022 and is subject to official publication.

Prime Minister of the Republic of Kazakhstan

A. Smailov

Approved by the Order of the Government of the Republic of Kazakhstan of November 25, 2022 No. 953

Rules of forming, maintaining and content of national collections of pathogenic and industrial microorganisms

Chapter 1. General provisions

1. These rules of forming, maintaining and content of national collections of pathogenic and industrial microorganisms (further – Rules) are developed according to the subitem 2) of article 8 of the Law of the Republic of Kazakhstan "About biological safety of the Republic of Kazakhstan" (further – the Law) and determine procedure for forming, maintaining and content of national collections of pathogenic and industrial microorganisms, including procedure for replenishment, accounting and centralized storage of unique pathogenic and industrial strains of the microorganisms including used as reference, isolated from various sources, test strains for standardization and control of immunobiological medicines and nutrient mediums, the production, deposited, patented and reference strains of microorganisms, and also other strains of the microorganisms which are of scientific, educational and practical value.

2. In these rules the following concepts are used:

1) the depositor – the legal entity who submitted the application for deposition of strain of microorganism;

2) strain simulator – the microorganism strain with the weakened virulence used for training, assessment (verification) of their quality characteristics, standardization and control of immunobiological medicines and nutrient medium;

3) deposition of strain of microorganism – transfer of strain of microorganism to national collection of pathogenic and industrial microorganisms, its registration and dead storage;

4) culture of microorganism – set (population) of the viable microorganisms which are grown up on nutrient medium;

5) reference (reference) strain – the microorganism strain used as an example for the purpose of comparison of taxonomical properties for diagnostic or other testings;

6) natural strain – the microorganism strain isolated (allocated) from people and components of the environment (animals, plants, water, the soil, air);

7) test strain (control) – strain of microorganism which is used in case of monitoring procedure of quality of laboratory researches (control of nutrient mediums, medicines, confirmation of correctness of laboratory methods, interpretations of results of the researches and other works requiring standardization);

8) national collection of pathogenic and industrial microorganisms (further – national collection) – collection of strains of pathogenic or industrial microorganisms;

9) microorganism strain – uniform culture of species of microorganism with certain biological properties;

10) the courier – the employee who is directly accompanying microorganisms to destination, having the admission to work with microorganisms of the corresponding group of pathogenicity;

11) working collection of pathogenic and industrial microorganisms (further – working collection) – the collection of strains of pathogenic and (or) industrial microorganisms created by the subject performing the treatment of pathogenic biological agents which is intended for the solution of specific current objectives within the scientific, production, diagnostic, research purposes.

3. National collections share on:

1) national collection in the sphere of sanitary and epidemiologic wellbeing of the population;

2) national collection in the field of veterinary science;

3) national collection in the field of science and biotechnologies.

4. The main requirement to maintenance of cultures in national collections is preserving their viability, authenticity and purity.

5. Forming, maintaining and content of national collections are performed by the organization included in the list of the organizations authorized on forming, maintaining and content of national collections of pathogenic and industrial microorganisms, approved according to the subitem 2) of article 8 of the Law (further – authorized organization), and got permission to the treatment of pathogenic biological agents (further – PBA) and appendix to it.

6. For the purpose of forming, maintaining and content of national collection by authorized organization obtaining, studying (identification), certification, deposition, accounting and temporary storage of strains of microorganisms are carried out.

7. The structure of national collections is created on signs of origin, specific relationship, method of their impact on human body, animal or plants and is supported in viable condition with preserving initial characteristics.

8. The authorized organization for the purpose of implementation of collection activities has the right to create working collection which forming, maintaining and content are performed according to the procedure, stipulated by the legislation the Republic of Kazakhstan.

The authorized organization in the presence of permission to the address from PBA and appendix to it stores the strains of microorganisms necessary for implementation of the current tasks, stipulated in Item 6 these rules in working collection:

1) reference (reference) strains;

2) test strains (control);

3) strains simulators;

4) the arrived natural strains;

5) the strains of microorganisms which are of scientific interest and which properties require additional studying.

9. Authorized organizations carry annually out inventory count of strains of the microorganisms which are stored in national and working collections with submission of information on results of the carried-out inventory count to authorized body of the respective area (sphere) of state regulation.

Authorized organizations within 24 months after enforcement of these rules carry out studying of strains of the microorganisms which are stored in working collections for the purposes of their further deposition to national collections and contents with submission of information on results of the carried-out studying and deposition to authorized body of the respective area (sphere) of state regulation.

The authorized body of the respective area (sphere) of state regulation within a month from the moment of receipt of information specified in the paragraph the second this Item provides this information in authorized body in the field of biological safety.

10. Financial provision of national collections is performed at the expense of budgetary funds.

National collections are property of the state and privatizations are not subject.

11. Authorized organizations give advisory and scientific and methodical help to physical persons and legal entities concerning systematization, studying, search and matching of strains of microorganisms by the established criteria taking into account the requirements provided for distribution of information of limited access according to the legislation of the Republic of Kazakhstan.

12. The first heads of authorized organizations are responsible for safety of collections of microorganisms.

13. In national collection in the sphere of sanitary and epidemiologic wellbeing of the population are subject to deposition:

1) the strains of microorganisms of I and II groups of pathogenicity which are unique, in particular:

strain of microorganism which analog is absent in national collection, including new, delivered from abroad;

microorganism strain, atypical on gene and phenotypical signs;

the microorganism strain isolated from atypical (various) sources (objects, regions);

2) atypical on gene and phenotypical signs or the strains of microorganisms of I and II groups of pathogenicity isolated from atypical (various) sources (objects, regions) used in case of production in the territory of the Republic of Kazakhstan of medicines and medical products for medical and veterinary application including attenuirovanny;

3) the strains of microorganisms of the I-IV groups of pathogenicity which are reference (reference) strains, test strains (control), strain simulators.

14. In national collection in the field of veterinary science are subject to deposition:

1) the strains of microorganisms causing especially dangerous diseases among animals and being unique, except for the I groups of pathogenicity, in particular:

strain of microorganism which analog is absent in national collection, including new, delivered from abroad;

microorganism strain, atypical on gene and phenotypical signs;

the microorganism strain isolated from atypical (various) sources (objects, regions);

2) the strains of microorganisms used in case of production and control in the territory of the Republic of Kazakhstan of veterinary medicines;

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