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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of December 8, 2020 No. KR DSM-240/2020

About approval of rules of use of medicines of the advanced therapy within exception of the standard procedure of the admission of medicine on the market, and also the list of the medical organizations having the right to perform treatment within Hospital exemption

According to Item 7 of article 243 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" PRIKAZYVAYU:

1. Approve the enclosed rules of use of medicines of the advanced therapy within exception of the standard procedure of the admission of medicine on the market, and also the list of the medical organizations having the right to perform treatment within Hospital exemption.

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

3) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan provision in Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

3. To impose control of execution of this order on the vice-Minister of Health of the Republic of Kazakhstan Giniyat And.

4. This order becomes effective on the expiration of ten calendar days from the date of its first official publication.

Minister of Health of the Republic of Kazakhstan

A. Tsoi

No. KR DSM-240/2020 are approved by the Order of the Minister of Health of the Republic of Kazakhstan of December 8, 2020

Rules of use of medicines of the advanced therapy within exception of the standard procedure of the admission of medicine on the market, and also the list of the medical organizations having the right to perform treatment within Hospital exemption

Chapter 1. General provisions

1. Rules of use of medicines of the advanced therapy within exception of the standard procedure of the admission of medicine on the market, and also the list of the medical organizations having the right to perform treatment within Hospital exemption (further - Rules) are developed according to Item 7 of article 243 of the Code of the Republic of Kazakhstan of July 7, 2020 "About health of the people and health care system" (further - the Code) and determine procedure for use of medicines of the advanced therapy within exception of the standard procedure of the admission of medicine on the market, and also establish the list of the medical organizations having the right to perform treatment within Hospital exemption.

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

1) the informed consent - the procedure of written voluntary confirmation by person of the consent to receipt of medical care and (or) participation in specific research after receipt of information on all significant for adoption of the decision by it aspects of medical care and (or) research;

2) 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;

3) 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;

4) exceptions of the standard procedure of the admission of medicine on the market (Hospital exemption) - the procedure of the admission of the unregistered medicine to clinical application in exclusive procedure in one medical organization for individual indications;

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

6) the head of research - person responsible for general performing clinical trial of safety for health of the person and the environment;

7) the research center - the organization based on which the preclinical (not clinical) research, clinical trial of medicines, medical products, clinical laboratory testing of medical products for diagnostics of in vitro is conducted;

8) clinical trial - the research with participation of the person as the subject conducted for identification or confirmation of safety and efficiency of means, methods and technologies of prevention, diagnostics and treatment of diseases;

9) the protocol of clinical trial (further - the protocol) - the document describing the purposes, design, methodology, statistical aspects and the organization of research;

10) the medical organization - the organization of health care which main activities is delivery of health care;

11) medicines of the advanced therapy (further - LSPT) - the medicines received in the biotechnological or bioengineering way which offer new opportunities for treatment of diseases and injuries, including means for gene therapy, somatic cellular therapy, fabric engineering;

12) the expert organization - the state expert organization in the sphere of drug circulation, medical products;

14) the subject (the subject of research) - the physical person participating in clinical trial as a part of the group receiving the researched medicine or as a part of control group.

Chapter 2. Procedure for use of medicines of the advanced therapy within exception of the standard procedure of the admission of medicine on the market

3. Medicines of the advanced therapy are applied without performing clinical trial within exception of the standard procedure of the admission of medicine on the market under condition:

1) availability of the positive conclusion of the local commission on bioethics;

2) availability of the scientific bases on use of medicine of the advanced therapy for direct advantage to the patient;

3) receipts of the informed consent of the patient or his legal representative on use of medicine of the advanced therapy.

The doctor appointing medicine of the advanced therapy provides observance of the specified conditions and by results of use of medicine of the advanced therapy within exception of the standard procedure of the admission of medicine on the market submits the report in the state expert organization in the sphere of drug circulation and medical products and the Commission on bioethics within fifteen working days after the end of procedure of treatment of the patient of LSPT.

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