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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of December 22, 2020 No. KR DSM-312/2020

About approval of rules of the admission to application, application and monitoring of efficiency and safety of use of medicines of the advanced therapy

According to Item 2 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 the admission to application, application and monitoring of efficiency and safety of use of medicines of the advanced therapy.

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 supervising vice-Minister of Health of the Republic of Kazakhstan.

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

Minister of Health of the Republic of Kazakhstan

A. Tsoi

No. KR DSM-312/2020 are approved by the Order of the Minister of Health of the Republic of Kazakhstan of December 22, 2020

Rules of the admission to application, application and monitoring of efficiency and safety of use of medicines of the advanced therapy

Chapter 1. General provisions

1. Rules of the admission to application, application and monitoring of efficiency and safety of use of medicines of the advanced therapy (further - Rules), are developed according to Item 2 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 the admission to application, application and monitoring of efficiency and safety of use of medicines of the advanced therapy.

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

1) the combined medicines for the advanced therapy - medicines of the advanced therapy, provided to combinations with medical product;

2) 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;

3) the state expert organization in the sphere of drug circulation and medical products (further - the state expert organization) - the subject of the state monopoly performing production economic activity in the field of health care on safety, efficiency and qualities of medicines and medical products;

4) 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;

5) the medical organization (further - MO) - the organization of health care which main activities is delivery of health care;

6) 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;

7) 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. The informed written consent is drawn up in the form approved by authorized body.

Chapter 2. Procedure for the admission to use of medicines of the advanced therapy

3. Medicines of the advanced therapy, made in industrial conditions, are allowed to application in clinical practice under condition:

1) availability of positive results of clinical trials;

2) state registration according to procedure for state registration, re-registration of medicine or medical product, modification of the registration file of medicine or medical product according to Item 3 of article 23 of the Code.

LSPT registered as medicines are allowed to medical application according to the indications specified in the relevant registration documents.

4. LSPT made for individual application concerning which positive results of clinical trials are received are allowed on the health care market based on the conclusion of the state expert organization without procedure of state registration.

5. For receipt of the conclusion on application of LSPT made for individual application, the applicant provides in the state expert organization:

1) the project of production schedules on production of LSPT;

2) description of physical properties and action of LSPT;

3) data of scientific and clinical trials on the offered LSPT and nozologiya to which treatment it is directed, and (or) the systematic reviews generalizing results of clinical trials at the republican and (or) world levels;

4) data on qualification of the specialists participating in production and medical process;

5) the certificate on compliance to requirements of the Standard of proper production practice (GMP).

6. In case of issue of the conclusion on application of LSPT made for individual application compliance to the requirements assuming risk assessment of LSPT is considered. For risk assessment of LSPT to consider factors: source of cages (autologichny, allogenny, ksenogenny), capability to profile, be differentiated and cause the immune answer, extent of change of cages, combination of cages with bioactive molecules or structural materials, long functionality onkogennost, method of application. Initial material, production process, the product characteristic and the strategy of control, ekstsipiyenta, scientific research, referensny materials is exposed to assessment. For issue of the conclusion on application of LSPT made for individual application the following requirements are observed:

1) LSPT are made for the specific patient on individual appointment of the attending physician;

2) LSPT are made not in industrial conditions and made from biological materials, including from cages and fabrics. LSPT are subdivided on autologichny, allogenny or ksenogenny origin;

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