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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of December 20, 2020 No. KR DSM-282/2020

About approval of rules of evaluating quality of the medicines and medical products registered in the Republic of Kazakhstan

(as amended on 07-06-2023)

According to the subitem 44) article 7 of the Code of the Republic of Kazakhstan "About health of the people and health care system" PRIKAZYVAYU:

1. Approve rules of evaluating quality of the medicines and medical products registered in the Republic of Kazakhstan according to appendix 1 to this order.

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 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.

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

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

Minister of Health of the Republic of Kazakhstan

A. Tsoi

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of December 20, 2020 No. KR DSM-282/2020

Rules of evaluating quality of the medicines and medical products registered in the Republic of Kazakhstan

Chapter 1. General provisions

1. These rules of evaluating quality of the medicines and medical products registered in the Republic of Kazakhstan (further – Rules) are developed according to the subitem 44) of article 7 of the Code of the Republic of Kazakhstan "About health of the people and health care system" (further – the Code) and determine procedure for evaluating quality of the medicines and medical products registered in the Republic of Kazakhstan.

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

1) 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;

2) 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;

3) quality evaluation of medicines and medical products (further – products quality evaluation) – determination of compliance of quality of medicines and medical products to data of the registration file, regulating documents on quality of medicines or documents on quality of medical products based on which they were registered in the Republic of Kazakhstan;

4) the supporting document quality of series of medicine – the document of the producer (the quality certificate / certificate the analysis / certificate of series / the analytical passport / protocol the analysis / test report) confirming compliance of quality of the declared medicine series to the quality indicators established in the regulating document on quality;

5) the supporting document quality of series of medical product – the document of the producer (the quality certificate / certificate the analysis / certificate the series / passport / the analytical passport / protocol the analysis / test report) confirming compliance of quality of medical product to the technical characteristics and parameters declared in the document on quality;

6) 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;

7) the applicant – the physical person or legal entity performing pharmaceutical activities in the Republic of Kazakhstan which provides products for quality evaluation;

8) the analysis of tendencies – methods of detection of the hidden main regularities of behavior of series of vaccines in the temporary sequence

9) the registration file – set of the documents and materials represented for examination of medicine, medical product.

3. Products quality evaluation according to Item 2 of article 241 of the Code belongs to the state monopoly and is performed by the expert organization on purpose:

1) determinations of quality of the registered products;

2) determinations of product quality, selected from the market taking into account risk - the oriented approach;

3) prevention of the address of counterfeited products in the market of the Republic of Kazakhstan.

4. Fee on evaluating product quality is made by the applicant into the account of the expert organization according to the prices established by authorized body in the field of health care in coordination with antimonopoly authority according to the order of the acting minister of health care of the Republic of Kazakhstan of January 20, 2021 No. KR DSM-7 "About price approval on the goods (works, services) made and (or) realized by the subject of the state monopoly" (further – the Order No. 7) (it is registered in the Register of state registration of regulatory legal acts at No. 22096).

5. The quality evaluation of products is performed in the following types:

1) examination of documents when declaring medicines on each series (batch), being specific amount of the medicine received as a result of engineering procedure or series of processes;

2) examination of documents when declaring medical products on each series (batch), the being set of assigned amount of the medical products made on general engineering procedure or the standard of the company;

3) examination of documents and laboratory researches of samples of medicines in case of serial assessment for producers of the Republic of Kazakhstan;

4) examination of documents and laboratory researches of samples of medical products in case of serial assessment for producers of the Republic of Kazakhstan;

5) examination of documents and laboratory researches of vaccines;

6) sampling of products from the market taking into account risk - the oriented approach.

To selection from the market taking into account risk - the oriented approach the medicines and medical products which passed quality evaluation according to subitems 1), 2), 3) and 4) of this Item according to Item 5 of the order of the acting minister of health care of the Republic of Kazakhstan of December 24, 2020 are subject to No. Ќ P 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" (it is registered in the Register of state registration of regulatory legal acts at No. 21923) (further – the Order No. 323).

6. The quality evaluation of products is carried out on each series (batch) of medicine and each series (batch) of medical product, made in the Republic of Kazakhstan or delivered to the Republic of Kazakhstan before the end of action of the registration certificate issued according to the order of the Minister of Health of the Republic of Kazakhstan of February 9, 2021 to No. KR DSM-16 "About approval of rules of state registration, re-registration of medicine or medical product, modification of the registration file of medicine or medical product" (it is registered in the Register of state registration of regulatory legal acts at No. 22175), the Eurasian economic commission registered according to the decision of Council of November 3, 2016 No. 78 "About rules of registration and examination of medicines for medical application" and the decision of Council of the Eurasian economic commission of February 12, 2016 No. 46 "About rules of registration and examination of safety, quality and efficiency of medical products".

7. For evaluating product quality by the types specified in subitems 1), 2), 3), 4), 5) of Item 5 of these rules, the applicant according to the Civil code of the Republic of Kazakhstan signs with the expert organization the contract for work on products quality evaluation.

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