ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of June 23, 2025 No. 58

About modification and amendments in the order of the Minister of Health of the Republic of Kazakhstan of June 7, 2023 No. 110 "About approval of rules of the organization and carrying out purchase of medicines, medical products and specialized medical products within the guaranteed amount of free medical care, additional amount of medical care for persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system at the expense of budgetary funds and (or) in system of compulsory social medical insurance, pharmaceutical services"

I ORDER:

1. Bring in the order of the Minister of Health of the Republic of Kazakhstan of June 7, 2023 No. 110 "About approval of rules of the organization and carrying out purchase of medicines, medical products and specialized medical products within the guaranteed amount of free medical care, additional amount of medical care for persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system at the expense of budgetary funds and (or) in system of compulsory social medical insurance, pharmaceutical services" (it is registered in the Register of state registration of regulatory legal acts at No. 32733) the following changes and amendments:

in rules of the organization and carrying out purchase of medicines, medical products and specialized medical products within the guaranteed amount of free medical care, additional amount of medical care for persons containing in pre-trial detention centers and organizations of criminal and executive (penitentiary) system at the expense of budgetary funds and (or) in the system of compulsory social medical insurance, pharmaceutical services (further – Rules) approved by the specified order:

in Item 2:

19) to state the subitem in the following edition:

"19) not reduced inventory of medicines and medical products - the inventory of the medicines and medical products necessary for uninterrupted provision of medicines established and which is systematically filled up by the single distributor at the expense of own means in amount to twenty five percent from the declared amount of medicines and (or) medical products subjects of health care according to the order of the Minister of Health of the Republic of Kazakhstan of August 20, 2021 No. KR DSM-88 "About determination of the list of the medicines and medical products which are purchased from the single distributor" (it is registered in the Register of state registration of regulatory legal acts at No. 24078) (further – the Order 88);";

add with subitem 33-1) of the following content:

"33-1) component part of medical product – the part of medical product which is not independent medical product including blocks, parts, the product elements, materials, spare parts provided by the producer for use according to functional purpose, operational characteristics, management of the producer on field service;";

state item 4 in the following edition:

"4. For the purpose of optimum and effective expenditure of the budgetary funds allocated for purchase of medicines and medical products within the guaranteed amount of free medical care, and means of compulsory social medical insurance medicines and medical products are bought at the prices which are not exceeding No. KR DSM-94 established by the Order 96 and the Order 77, the order of the acting minister of health care of the Republic of Kazakhstan of August 27, 2021 "About ceiling approval of prices of the producer for the trade name of medicine, ceiling prices for the trade name of medicine for retail and wholesale" (it is registered in the Register of state registration of regulatory legal acts at No. 24229) (further – the Order 94) except for of the unregistered medicines and medical products, imported on the territory of the Republic of Kazakhstan based on the conclusion (the allowing document) issued by authorized body in the field of health care.";

state Item 5-2 in the following edition:

"5-2. Customers perform purchase of medicines and medical products of 4-1 Section 3 of these rules which is not included in the Order 88 according to Chapters 1, in 3, of 4,.";

2) of Item 7 to state the subitem in the following edition:

"2) from one source, including by means of the web portal;";

1) of Item 11 to state the subitem in the following edition:

"1) availability of state registration in the Republic of Kazakhstan, except for the medicines made in the drugstores, component parts which are part of product of medical appointment, not used as independent product, the unregistered medicines, medical products imported on the territory of the Republic of Kazakhstan based on the conclusion (the allowing document).

In case of purchase of medical equipment in the special vehicle – availability of state registration in the Republic of Kazakhstan as single portable medical complex.

Lack of need of registration of the component part of medical equipment (from delivery set) is confirmed by the letter of the expert organization or authorized body in the field of health care;

At the same time exceeding of the offered functional, technical, quality and operational characteristics of medical equipment to requirements of the technical specification is allowed;";

state Item 14 in the following edition:

"14. If one potential supplier who is domestic producer and (or) the producer of state members of the Eurasian Economic Union (further – EEU), submitted the request corresponding to conditions of the announcement or invitation to purchase and conditions of these rules participates in purchase on lot, such potential supplier is recognized the winner, and requests of other potential suppliers automatically are rejected, except for purchase of medical equipment worth over 20 million tenges for unit, performed through the Single distributor.

In case of the purchase of medical equipment worth over 20 million tenges for unit performed through the Single distributor one potential supplier who is domestic producer and (or) the producer of state members of the Eurasian Economic Union (further – EEU), submitted the request corresponding to conditions of the announcement or invitation to purchase and conditions of these rules participates in case when in purchase on lot, the conditional discount in the amount of 20% at auction stage of the purchase price is provided to such potential supplier.";

state Items 16 and 17 in the following edition:

"16. The status of domestic producer of the potential supplier when carrying out purchase is confirmed by the following documents:

1) the license for pharmaceutical activities for production of medicines and (or) medical products received according to the legislation of the Republic of Kazakhstan on permissions and notifications.

2) the registration certificate on medicine or medical product 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), with indication of domestic producer as the producer.

Within the conclusion of the agreement or the supplementary agreement to the long-term agreement of delivery the domestic producer represents by delivery to the delivered amount of medicines and medical products the certificate of origin of medicines, medical products for the internal address of "CT-KZ".

17. The status of the potential manufacturing supplier of state members of EEU is confirmed by the following documents:

1) the license for pharmaceutical activities for production of medicines and (or) medical products received according to the legislation of the Republic of Kazakhstan on permissions and notifications;

2) the registration certificate, corresponding to the decision of Council of EEU of November 3, 2016 No. 78 "About Rules of registration and examination of medicines for medical application" and to the decision of Council of EEU of February 12, 2016 No. 46 "About Rules of registration and examination of safety, quality and efficiency of medical products";

3) the certificate of ISO 13485, (for medical products 2a (sterile) safety of class and 2b and 3 classes of safety).";

add Section 1 with Chapter 4 following of content:

"Chapter 4. Examination

21-1. The customer, the organizer of purchase or the single distributor attracts to purchase (in need of) the expert or experts of profile specialties in the questions requiring special knowledge and (or) technical knowledge.

The customer and (or) the organizer of purchase determines experts for financial year by profile specialties for examination of requests regarding compliance of pharmaceutical service, medicines and (or) medical products to the description, characteristics or technical specifications in the announcement or the invitation.

At the same time customers and (or) organizers of purchase bear responsibility for compliance of experts to the subitem 45) of Item 2 of these rules.

The authorized body in the field of health care determines lists of experts in profile specialties for separate financial year for the purchase which is carried out by the single distributor.

For examination of the offered medicines experts in the field of clinical pharmacology in addition are attracted.

For examination of tenders in case of purchase of medical equipment worth over 20000000 (twenty million) tenges the authorized body determines at least two experts for ensuring interchangeability within financial year.

21-2. Person cannot be the expert:

1) interested in results of procedures of purchase (representatives of the single distributor, the potential supplier);

2) being the close relative, the spouse (spouse) or the cousin-in-law of the first head of the single distributor, the customer or the organizer of purchase.

21-3. The expert has no right to vote in case of decision making about purchase.

The expert opinion has advisory nature and is considered in case of decision making about purchase.

21-4. In case of involvement of the expert for purchase on the web portal conducting examination is performed in the following procedure:

1) experts are registered on the web portal as its users;

2) the member of the commission by means of the web portal sends to the secretary the notification on need of receipt of the expert opinion on the corresponding lot not later than 2 (two) working days before the expiration of the publication of the protocol of vote;

3) the secretary of the commission after receipt of the notification on need of receipt of the expert opinion by means of the web portal without delay sends to the corresponding expert the notification on need of submission of the expert opinion on lot. In case of receipt on the same lot of the notification on need of the expert opinion from other member of the tender commission, the renewed notification to the expert does not go. In case of purchase of medicines and products of medical appointment the notification goes with specification of the questions which are subject to studying by the involved experts.

4) the web portal automatically distributes to members of the commission the expert opinion after its signing by the expert.

21-5. In case of involvement of the expert for the purchase which is carried out on paper the expert opinion it is drawn up in writing, signed by the expert and applied to the minutes of the commission.

The expert opinion is registered the secretary and is not subject to response and (or) replacement.

21-6. The member of the commission in case of disagreement with the expert opinion does not take it into account.

If the request of the potential supplier is rejected based on the expert opinion, it is published by the secretary along with the protocol of vote.

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