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I.O'S ORDER. MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of December 24, 2020 No. KR DSM-323/2020

About approval of rules of selection from the market, including in the medical organizations, medicines and the medical products which are subject to quality control taking into account risk - the oriented approach

According to the subitem 20) article 10 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 selection from the market, including in the medical organizations, medicines and the medical products which are subject to quality control taking into account risk - the oriented approach.

2. To provide to committee of medical and pharmaceutical control 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 submission to 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 after day of its first official publication.

Acting minister of health care of the Republic of Kazakhstan

M. Shoranov

Appendix

to the Order of the Acting minister of health care of the Republic of Kazakhstan of December 24, 2020 No. KR DSM-323/2020

Rules of selection from the market, including in the medical organizations, medicines and the medical products which are subject to quality control taking into account risk - the oriented approach

Chapter 1. General provisions

1. These rules of selection from the market, including in the medical organizations, medicines and the medical products which are subject to quality control taking into account risk - the oriented approach (further - Rules) are developed according to the subitem 20) of article 10 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 establish procedure for selection from the market, including in the medical organizations, medicines and the medical products which are subject to quality control taking into account risk - the oriented approach (further - sampling).

2. For the purposes of these rules the following terms and determinations are applied:

1) authorized body in the field of health care (further - authorized body) - the central executive body performing management and cross-industry coordination in the field of protection of public health of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation and medical products, qualities of rendering medical services (help);  

2) state body in the sphere of drug circulation and medical products (further - state body) - the state body performing management in the sphere of drug circulation and medical products, control of drug circulation and medical products;

3) the state expert organization in the sphere of drug circulation and medical products (further - the 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) products - the medicines and medical products registered according to the procedure, stipulated in Item 3 articles 23 of the Code and allowed for medical application in the Republic of Kazakhstan.

3. Sampling is made annually by specialists of the expert organization performing quality evaluation of medicines and medical products according to the procedure, stipulated in Item 1 article 241 of the Code.

4. The expert organization annually till December 10 creates the plan of sampling for quality evaluation of the medicines which are in circulation in the territory of the Republic of Kazakhstan and medical products and sends it for review to producers (holders of registration certificates of medicines, authorized representatives of the producer of medical products) or their authorized representatives (further - the producer). In the absence of coordination by the producer within 30 calendar days from the date of receipt of request from the expert organization, the expert organization within 10 calendar days sends the notification (in any form) to state body about acceptance of adequate measures.

Review or entering of adjustments into the plan of sampling is performed by the expert organization quarterly depending on again registered medicines and medical products, and also absence in the market of the medicines and medical products included in the plan of selection.

5. Are subject to inclusion in the plan of sampling:

1) the medicines requiring special storage conditions;

2) the medicines which are purchased within the guaranteed amount of free medical care and obligatory system of medical insurance;

3) the medicines for the first time registered in the territory of the Republic of Kazakhstan;

4) medicines, parenteral introduction;

5) the sterile medicines and medical products, and also the medical products which are individual protection equipment, intended by the producer for protection of patients or medical personnel and applied in the medical purposes to individual protection except for implanted and medical products for diagnostics of in vitro, and also medical equipment.

Chapter 2. Procedure for selection from the market, including in the medical organizations, medicines and the medical products which are subject to quality control taking into account risk - the oriented approach

6. Sampling is made in the organizations for production of the medicines and medical products, the organizations enabling the wholesale and retail realization of medicines and medical products (the drugstore including enabling the realization on the Internet, pharmaceutical Items in the organizations of health care, pharmaceutical, distributor warehouses, warehouses of temporary storage of medicines, medical products, shops of optics, shops of medical products) and also in the organizations of health care in the presence of the manufacturer representative.

7. Sampling is performed in the quantity necessary for single laboratory testing.

When sampling the sampling report of products in form according to appendix to these rules is drawn up.

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