Amendments to the List of Medicines Subject to Price Regulation for Wholesale and Retail Sale

By Order of the Minister of Health of the Republic of Kazakhstan dated June 18, 2025 No. 394 ("Order No. 394"), amendments were made to the List of Medicines Subject to Price Regulation for Wholesale and Retail Sale approved by Order of the Acting Minister of Health of the Republic of Kazakhstan dated December 1, 2022 No. KR DSM-150.

In accordance with the amendments, the number of medicines on the List Subject to Price Regulation for Wholesale and Retail Sale has been reduced from 6,060 to 5,408. Over-the-counter Medicines have been excluded from the list. Order No. 394 came into force on July 5, 2025.

Amendments to the Rules for Regulation of Prices for Medicines and Medical Devices

By the Order No. 59 of the Minister of Healthcare of the Republic of Kazakhstan dated June 24,

2025 ("Order No. 59"), amendments were made to the Rules for Regulating, Setting Maximum Prices and Markups for Medicines, as well as Medical Devices ("MD") within the Guaranteed Volume of Free Medical Care ("GVFMC") and/or in the Obligatory Social Medical Insurance ("OSMI") System approved by Order No. ҚР ДСМ-247/2020 of the Minister of Healthcare of the Republic of Kazakhstan dated December 11, 2020 ("Rules for Regulation of Prices for Medicines and MD"). The amendments related to Medicines concerned the following:

the three minimum prices among the maximum prices for the trade name of the Medicine within the framework of the GVFMC and/or in the OSMI system[2].

MD

Amendments to the Rules for Registration and Examination of Medicines for Medical Use in the Eurasian Economic Union[7].

On June 21, 2025, amendments introduced by the Decision of the Council of the Eurasian Economic Commission (“EEC”) dated May 22 No. 34 (“Decision No. 34”) to the Decision of the Council of the EEC No. 78 dated November 3, 2016 “On the Rules for Registration and Examination of Medicines for Medical Use” (“Decision No. 78”) came into force.

In order to speed up the transition to EAEU regulation, restrictions on the simultaneous implementation of mutual recognition procedures and introduction of amendments to the registration dossier of a pharmaceutical product have been lifted.

Decision No. 34 contains clarifications of a number of provisions governing the procedure for registration of Medicines during the transition period. Thus, the registration certificates issued in accordance with the legislation of the EAEU member states remain in force until their expiration but not later than December 31, 2025. In the event that an application for bringing the registration dossier of a pharmaceutical product into compliance with the requirements of the EAEU has been submitted to the authorized body or expert organization of the reference state before December 31, 2025, the registration certificates shall be extended8:

If the procedure has already been completed in the reference state before 31 December 2025, marketing authorizations shall be extended in the recognition states for the period of completion of the procedure - but not more than for 2 years from 31 December 2025[8].

The authorized bodies of the Member States have the right to indicate information on the registration status of a pharmaceutical product in their registers[9].

In addition, the possibility of providing an alternative package of GMP supporting documents subject to inspection within 3 years of registration provided by paragraph 30 of Decision No. 78

is now given indefinitely without a certain deadline. At the same time, paragraph 159 has been clarified on the consequences of failure to fulfill this obligation.

An updated structure of the expert report and its annexes, consistent with the practice of authorized bodies and expert organizations, has also been introduced. The provisions concerning the possibility of making changes to the registration dossier in the reference state during the recognition procedure in the recognition states being carried out, as well as approaches to making changes that relate exclusively to the recognition states, have been clarified.

Amendments to the Rules for the Procurement of Medicines and Medical Devices

By Order No. 58 of the Minister of Health of the Republic of Kazakhstan dated June 23, 2025

("Order No. 58"), amendments were made to the Rules for the Organization and Conduct of Procurement of Medicines, MD and Specialized Medical Products within the Framework of the GVFMC, Additional Volume of Medical Care for Persons Held in Pre-trial Detention Facilities and Institutions of the Penal (Penitentiary) System, at the Expense of Budgetary Funds and/or in the OSMI system, Pharmaceutical Services, approved by Order No. 110 of the Minister of Health of the Republic of Kazakhstan dated June 7, 2023 ("Procurement Rules"). The amendments include the following:

Republic of Kazakhstan dated August 27, 2021 No. КР ДСМ-94 "On Approval of the

Maximum Prices of the Manufacturer for the Trade Name of the Medicine, Maximum Prices for the Trade Name of the Medicine for Retail and Wholesale Sale"[11].

Tender

2) to purchase Medicines containing narcotic, psychotropic substances and precursors.

requesting price quotations from domestic and foreign manufacturers or through international organizations established by the UN) [20].

Purchase of Medical Equipment through Tender

Purchase by Requesting Price Quotations from Domestic and Foreign Manufacturers or through International Organizations Established by the UN

▪ A rule has been introduced that if the procurement of Medicines and/or MD through international organizations established by the UN is recognized as having failed, the procurement shall be carried out in accordance with paragraph 2 of Chapter 2 of Section 3 of the Procurement Rules entitled “Procedure for Procurement from a Domestic or Foreign Manufacturer” (previously - through a special purchase procedure)[26].

Single Source Procurement

▪ A rule has been introduced that if a single-source procurement fails, the purchase price of the Medicines and/or MD which haven’t been purchased must not exceed the purchase price for the relevant financial year, in case the trade name, characteristics, unit of measurement, manufacturer and country of manufacture specified in the application (price offer) of the potential supplier are identical to the Medicine and/or MD, the single-source procurement of which was declared as having failed[27]. A rule has also been introduced that in the event of a full or partial refusal by the supplier to supply an additional volume, as well as in the event of unilateral termination of the supply agreement by the SD in the current financial year, a repeat purchase shall be made at a price not exceeding the fixed price established in the previously concluded supply agreement in the same financial year[28].

Purchase by Request for Quotations

▪ New grounds for conducting procurement by requesting price quotations have been added, such as[29]:

­ violation by the SD of delivery deadlines under a purchase agreement concluded between the SD and a customer;

­ failed purchases of Medicines, MD or pharmaceutical services carried out by the SD in the ways established by the Procurement Rules. In this case, the purchase shall be carried out for up to a sixty-day need for Medicines or MD, as well as up to a ninety-day need for pharmaceutical services.

Conclusion of a Supply Contract

▪ A provision has been introduced that if the maximum price for the INN and/or trade name of a Medicine and/or MD changes upward during the supply contract being performed, the supply contract shall remain in effect until the parties have fully fulfilled their obligations at the previous price. If the maximum price for the INN and/or trade name of a Medicine and/or MD changes downward during the supply contract being performed, the SD shall negotiate with the supplier in order to reduce the price of the supply contract. In the event of disagreement regarding the reduction of the price of the supply contract or the supplier's refusal to negotiate, the SD has the right to

terminate the supply contract and conduct the procurement in the manner established by the Procurement Rules[30].

Competition for the Conclusion of Long-term Supply Contracts for the Creation and/or Modernization of the Production of Medicines and/or MD

▪ The requirement to provide the CT-KZ certificate in order to conclude an addition

al agreement for the relevant financial year has been omitted[31].

The Procedure for the Formation and Use of Medicines and MD of the Minimum Stock of the SD

Amendments were also introduced to the annexes to the Procurement Rules, namely:

The following new annexes have been added:

The Order No. 58 entered into force on July 11, 2025, with the exception of the provisions that enter into force on July 31, 2025 (see the text of this Alert above).

Contacts:

Zafar Vakhidov

Partner, Vakhidov & Partners   Kazakhstan/ Uzbekistan

[email protected]

Saltanat Zhakhina                           

Associate,  Vakhidov & Partners   Kazakhstan

[email protected]

[1] sp. 1, p. 24, sp. 1, p. 51 of the Rules for Regulation of Prices for Medicines and MD as amended by Order No. 59;

[2] p. 62, Rules for Regulation of Prices for Medicines as amended by Order No. 59;

[3] p. 41, 57, Rules for Regulation of Prices for Medicines as amended by Order No. 59;

[4] p. 42, Rules for Regulation of Prices for Medicines as amended by Order No. 110;

[5] sp. 1, p. 5, Rules for Regulation of Prices for Medicines as amended by Order No. 59;

[6] . 26 Rules for Regulation of Prices for Medicines as amended by Order No. 59;

[7] https://pharmreviews.kz/novosti/novosti-eaes/vstupili-v-silu-izmeneniya-uproshchayushchie-registratsionnye-protsedurylekarstv-na-rynke-eaes ; 8 sp. д, е, p.2, Decision No. 78;

[8] sp. е, p. 2, Decision No. 78;

[9] sp. ж, p. 2, Decision No. 78;

[10] p. 2 of the Procurement Rules;

[11] p. 4 of the Procurement Rules;

[12] sp. 1, p. 11 of the Procurement Rules as amended by Order No. 58;

[13] . 14 of the Procurement Rules as amended by Order No. 58;

[14] p. 146-1 of the Procurement Rules as amended by Order No. 58;

[15] p. 146 -2 of the Procurement Rules as amended by Order No. 58;

[16] p. 197 of the Procurement Rules as amended by Order No. 58;

[17] p. 200 of the Procurement Rules as amended by Order No. 58;

[18] p. 210 of the Procurement Rules as amended by Order No. 58;

[19] . 210 of the Procurement Rules as amended by Order No. 58;

[20] p. 221 of the Procurement Rules as amended by Order No. 58;

[21] p. 221 of the Procurement Rules as amended by Order No. 58;

[22] p. 228 of the Procurement Rules as amended by Order No. 58;

[23] p. 153 of the Procurement Rules as amended by Order No. 58;

[24] p. 198 of the Procurement Rules as amended by Order No. 58;

[25] p. 206 of the Procurement Rules as amended by Order No. 58;

[26] . 237-1 of the Procurement Rules as amended by Order No. 58;

[27] p. 241 of the Procurement Rules as amended by Order No. 58;

[28] p. 241-1 of the Procurement Rules as amended by Order No. 58;

[29] sp. 5, 6, p. 245-1 of the Procurement Rules as amended by Order No. 58;

[30] p. 259 of the Procurement Rules as amended by Order No. 58;

[31] p. 344 of the Procurement Rules as amended by Order No. 58;

[32] p. 441-3 of the Procurement Rules as amended by Order No. 58;

[33] . 445 of the Procurement Rules as amended by Order No. 58;