ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of January 23, 2026 No. 6

About modification and amendments in the order of the acting minister of health care 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"

I ORDER:

1. Bring in the order of the acting minister of health care 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 (it is registered in the Register of state registration of regulatory legal acts at No. 21923) the following changes and amendments:

in 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, approved by the specified order:

state item 4 in the following edition:

"4. The state body till October 1 sends to the expert organization by means of electronic document management system information in any form of medicines and medical products with the revealed discrepancies for the previous 3rd years by results of pharmaceutical control, inspection, according to the order of the Minister of Health of the Republic of Kazakhstan of January 27, 2021 to No. KR DSM-9 "About approval of rules of conducting pharmaceutical inspections on proper pharmaceutical practicians" (it is registered in the Register of state registration of regulatory legal acts at No. 22143) (further - the order No. KR DSM-9), and the order of the Minister of Health of the Republic of Kazakhstan of December 23, 2020 No. KR DSM-315/2020 "About approval of rules of conducting inspections of medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 21898) (further - the order No. KR DSM-315/2020), pharmakonadzor according to the order of the Minister of Health of the Republic of Kazakhstan of December 23, 2020 No. KR DSM-320/2020 "About approval of rules of carrying out pharmakonadzor and monitoring of safety, quality and efficiency of medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 21896) (further - the order No. KR DSM-320/2020).

The expert organization annually till October 15 develops and directs by means of electronic document management system to state body the plan of sampling for quality evaluation of the medicines and medical products which are in circulation in the territory of the Republic of Kazakhstan the next calendar year (further - the Plan) in any form for approval.

In case of availability of discrepancies with Item 5 of these rules, regarding inclusion of medicines and medical products in the Plan, state body within 5 working days from the date of receipt of the Plan sends to the expert organization by means of electronic document management system the draft of the Plan for completion.

The expert organization within 3 working days from the moment of receipt of notes from state body directs the modifed Plan for approval of state body.

The state body annually till November 1 approves the Plan and sends by means of electronic document management system to the expert organization for placement it in open entry on official Internet resource of the expert organization.";

add with Item 4-1 of the following content:

"4-1. Review and entering of adjustments into the Plan is performed on semi-annual basis taking into account information from the single distributor on medicines and medical products according to the trade names which were purchased within the guaranteed amount of free medical care and (or) system of compulsory social medical insurance after forming of the plan of selection and also by results of the state control in the field of drug circulation and medical products, including pharmakonadzor and inspections.

The expert organization annually till June 15 sends by means of electronic document management system to state body the project about modification and (or) amendments to the Plan in any form for approval.

In case of availability of discrepancies with Item 5 of these rules, regarding inclusion of medicines and medical products in the Plan, state body within 5 working days from the date of receipt of the project about modification and (or) amendments in the Plan sends to the expert organization by means of electronic document management system the project about modification and (or) amendments in the Plan for completion.

The expert organization within 3 working days from the moment of receipt of the project about modification and (or) amendments in the Plan sends the modifed project about modification and (or) amendments to the Plan for approval of state body.

The state body till July 1 approves modification and (or) amendments in the Plan and sends by means of electronic document management system to the expert organization for placement of the updated Plan in open entry on official Internet resource of the expert organization.";

add with Item 4-2 of the following content:

"4-2. The expert organization signs the contract with the producer (the holder of registration certificates of medicines, the authorized representative of the producer of medical products) or his authorized representatives (further - the producer) products included in the Plan, on carrying out testing of product samples, selected from the market taking into account risk - the oriented approach, within 15 working days from the moment of the appeal of producer.

The expert organization within 10 working days from the date of the conclusion of the contract for carrying out testing of product samples, selected from the market taking into account risk - the oriented approach, creates the schedule of sampling of products and sends it for approval to the producer.

The producer approves the schedule of sampling of products within 30 calendar days from the date of its obtaining. In the absence of approval 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.

Review or entering of adjustments into the schedule of sampling of products is performed by the expert organization within 10 working days after receipt of the written request (in any form) from the producer.";

add with Item 4-3 of the following content:

"4-3. For decision making about suspension of the existing certificates of conformity of products issued according to the 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" (it is registered in the Register of state registration of regulatory legal acts at No. 21836), the expert organization following the results of calendar year till January 15 of year of the following behind the accounting period sends to state body information (in any form) on products:

1) included in the plan, but not last selection, in connection with not conclusion the producer of the contract for carrying out testing of product samples, selected from the market taking into account risk - the oriented approach;

2) included in the plan on which the contract for carrying out testing of product samples is signed, selected from the market taking into account risk - the oriented approach, but carrying out sampling in accordance with the terms of the agreement is not provided.";

2) of Item 5 to state the subitem in the following edition:

"2) the medicines and medical products according to trade names which were purchased within the guaranteed amount of free medical care and (or) system of compulsory social medical insurance by the single distributor as of date of forming of the plan of selection, except for orphan medicines, the implanted medical products and medical products for diagnostics of in vitro, and also medical equipment;".

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.

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info