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The document ceased to be valid since May 14, 2018 according to Item 2 of the Order of the Minister of Health of the Republic of Kazakhstan of April 2, 2018 No. 142

ORDER OF THE MINISTER OF HEALTH AND SOCIAL DEVELOPMENT OF THE REPUBLIC OF KAZAKHSTAN

of May 29, 2015 No. 415

About approval of Rules of carrying out preclinical researches, requirements to preclinical bases

According to Item 2 of article 72 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve Rules of carrying out preclinical (not clinical) researches of biologically active agents, pharmacological, medicines, products of medical appointment and medical equipment according to appendix to this order.

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) within ten calendar days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan the direction on official publication in periodic printing editions and information system of law of regulatory legal acts of the Republic of Kazakhstan of Ad_let;

3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan.

3. Declare invalid the order of the Minister of Health of the Republic of Kazakhstan of November 19, 2009 No. 745 "About approval of Rules of carrying out preclinical (not clinical) researches of biologically active agents" (registered in the Register of state registration of regulatory legal acts for No. 5914, No. published in the Collection of acts of the central executive and other central state bodies of the Republic of Kazakhstan 3, 2010).

4. To impose control of execution of this order on the vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.

5. This order becomes effective after ten calendar days after day of its first official publication.

Minister of health and social development of the Republic of Kazakhstan

T. Duysenova

Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of May 29, 2015 No. 415

Rules of carrying out preclinical (not clinical) researches

1. General provisions

1. These rules of carrying out preclinical (not clinical) researches (further – Rules) are developed according to Item 2 of article 72 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further – the Code) and determine complex of pilot pharmacological, toxicological and other scientific research of biologically active agents, pharmacological and medicines, products of medical appointment and medical equipment for the purpose of studying of their efficiency and safety.

2. The purpose of preclinical (not clinical) researches of pharmacological, toxicological and other scientific research of biologically active agents, pharmacological and medicines, products of medical appointment and medical equipment is studying of their efficiency and safety.

3. Preclinical (not clinical) researches are conducted in cases:

1) developments of new original biologically active agents, pharmacological, medicines, products of medical appointment and medical equipment as domestic manufacturers or developers for the purposes of performing clinical trials and registration;

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