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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of April 2, 2018 No. 142

About approval of Rules of carrying out preclinical (not clinical) researches, clinical trials, clinical laboratory testing of medical products for diagnostics of in vitro, and also requirements to preclinical and clinical bases

(In edition of the Order of the Minister of Health of the Republic of Kazakhstan of 24.06.2019 No. KR DSM-96)

According to Item 2 of Article 72, Item 3 of Article 74 and Item 11 of article 180 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, clinical trials, clinical laboratory testing of medical products for diagnostics of in vitro, and also requirements to preclinical and clinical bases.

2. Recognize invalid some orders of the Ministry of Health of the Republic of Kazakhstan according to appendix 2 to this order.

3. To provide to department of science and human resources of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation 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 from the date of state registration of this order the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "The republican center of legal information" for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) within ten calendar days after state registration of this order the direction it the copy on official publication in periodic printing editions;

4) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

5) within ten working days after state registration of this order submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2), 3) and 4) of this Item.

4. To impose control of execution of this order on the vice-Minister of Health of the Republic of Kazakhstan Aktayeva L. M.

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

Minister of Health of the Republic of Kazakhstan

E.Birtanov

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of April 2, 2018 No. 142

Rules of carrying out preclinical (not clinical) researches, clinical trials, clinical laboratory testing of medical products for diagnostics of in vitro, and also requirement to preclinical and clinical bases

Chapter 1. General provisions

1. Rules of carrying out preclinical (not clinical) researches, clinical trials, clinical laboratory testing of medical products for diagnostics of in vitro (further - Rules), and also requirements to preclinical and clinical bases are developed according to Item 2 of Article 72 and Item 3 of article 74 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 procedure for carrying out preclinical (not clinical) researches, clinical trials of medicines and medical products, clinical laboratory testing of medical products for diagnostics of in vitro, and also establish requirements to preclinical and clinical bases.

2. These rules extend on:

1) preclinical (not clinical) researches, medicines and research (testing) of assessment of biological effect of medical products;

2) clinical trials of medicines, medical products, clinical laboratory testing of medical products for diagnostics of in vitro.

3. In these rules the following terms and determinations are used:

1) the informed consent - the procedure of voluntary confirmation by the subject of research or its legal representative of consent to participation in specific research after receipt of information on all significant for adoption of the decision by it aspects of research;

2) unforeseen undesirable reaction - undesirable reaction, nature, severity or outcome of which do not correspond to information the existing instruction on medical application of medicine or the brochure of the researcher for the unregistered medicine;

3) biological equivalence (bioequivalence) - lack of significant distinctions on the speed and degree with which active ingredient or active part of molecule of active ingredient of pharmaceutical equivalents or pharmaceutical alternatives become available in the place of the action in case of introduction in identical molar dose in similar conditions in research with proper design;

4) bioequivalence research - comparative studying of bioavailability for the purpose of establishment of pharmacokinetic equivalence between the tested medicine and medicine of comparison;

5) bioethical examination - consideration of biomedical research and issue of the reasonable conclusion of the Commission on bioethics from line item of the ethical acceptability, safety for participants and feasibility of this research;

6) medicine - the means representing or containing the substance or combination of substances coming into contact with human body, intended for treatment, prevention of diseases of the person or recovery, correction or change of its physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;

7) exception of the standard procedure of clinical trial of medicine - the procedure of the admission of the unregistered medicine to clinical application in exclusive procedure in one medical organization for individual indications;

8) the sponsor - physical person or legal entity, responsibility for its organization and (or) financing being the initiator of clinical trial and bearing;

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