Uzbekistan

On 12 May 2025, the Minister of Health of the Republic of Uzbekistan (the “Uzbekistan”) issued the Order “On Amendments and Additions to the Order ‘On Approval of the Regulation on the Procedure for Accounting Medicine Prices within the Reference Pricing System’” No. Order-3242–1 dated 12 May 2025 (the “Order No. 3242–1”). Below is an overview of the key changes introduced to the regulation of the reference pricing for prescription medicines as set forth in the Order No. 3242–1. Deregulation of prices to OTC medicines Pursuant to the Order No. 3242–1, in the Regulation “On Approval of the Procedure for Accounting Medicine Prices within the Reference Pricing System” (the “Regulation”), approved by the Order of the Minister of Health of Uzbekistan No. Order-3242 dated 10 June 2020, the term “medicine” has been replaced with “prescription medicine.” As a result of these changes, the Regulation now governs prices solely for prescription medicines. Update of the List of Reference Countries In accordance with the Order No. 3242–1, Annex No. 2 to the Regulation, which contains the list of reference countries (the “List”), has been revised. Specifically, the List now excludes the following countries: the Republic of Tajikistan, the Republic of Slovenia, and the Kyrgyz Republic. At the same time, the List has been supplemented with the following countries: the Arab Republic of Egypt, the Republic of Turkey, and the Republic of Romania. Introduction of an Alternative Procedure for Price Confirmation in the Absence of Data from Reference Countries The Regulation has been supplemented with a provision establishing an alternative procedure for confirming prices of imported prescription medicines when price information is unavailable from two or more reference countries. In such cases, the applicant must provide an export customs declaration issued in the country of manufacture. If the declaration does not indicate the value of the produce or if the legislation of the country of origin does not require an export declaration, an alternative replacement document may be submitted. Specifically, such a document may be an agreement between the manufacturer and the distributor, provided the agreement is registered in the country of origin and includes the following information: the name and details of the exporter and importer, the value and quantity of the goods imported into the customs territory of Uzbekistan. Introduction of an Automatic Indexation Mechanism for Maximum Prices In accordance with the Order No. 3242–1, the maximum prices of imported prescription medicines in the register of maximum prices during their registration or re-registration are subject to automatic indexation to the national currency of Uzbekistan. The indexation is performed twice a year – on 1 January and 1 July – based on the official foreign currency exchange rate set by the Central Bank of Uzbekistan. Automatic indexation applies only to medicines whose last recorded maximum price has increased by at least 3% as a result of an increase in the foreign currency exchange rate relative to the price of the medicine in the national currency. If the increase in the foreign currency exchange rate causes the last recorded maximum price to rise by more than 5%, automatic indexation is carried out regardless of the scheduled dates of planned maximum price indexation (1 January and 1 July of each year). Revised Terms and Grounds for Re-registration of Maximum Prices for Medicines According to the amendments, an application for re-registration may be submitted no earlier than six months from the date of the initial registration of the maximum price. The revised Regulation stipulates that an application for re-registration of maximum prices may be submitted no earlier than six months from the date of the maximum price registration. The applicant is required to attach supporting documents specifying the particular reasons for the price increase. Furthermore, the Order No. 3242–1 revised the grounds for re-registration of maximum prices for prescription medicines. The updated Regulation provides that re-registration of maximum prices before the established six-month period is allowed exclusively in the event of force majeure circumstances arising in the country of manufacture of the respective medicines. Introduction of a Calculation Form for the Selling Price of Domestic Medicines In accordance with the Order No. 3242–1, a new Annex No. 1 has been added to the Regulation, establishing the form for calculating the selling price of domestic prescription medicines. The form is structured according to the main cost categories and includes the following elements: the cost price of the medicine, detailed by its constituent components, other expenses, including administrative costs, promotional expenses, operational, and financial costs, the total expenses line, calculated as the sum of all specified costs, the net profit margin expressed as a percentage, the calculation of the retail price per packaging unit of the medicine – both excluding and including VAT. General Amendments to the Regulation Expanded Obligations of the Pharmaceutical Industry Development Agency  Regarding the Publication of Information on Maximum Prices According to the amendments introduced by the Order No. 3242–1, the Pharmaceutical Industry Development Agency is now required to continuously publish this information on registered and re-registered maximum prices on the Unified Portal of Interactive Public Services, in addition to the official website of the Pharmaceutical Industry Development Agency. The Maximum Share of Other Expenses Increased from 1% to 2% The Regulation was amended to revise the procedure for applying maximum trade margins in wholesale and retail sale of imported and domestic medicines, as well as the formula for calculating their purchase cost. Specifically, the “other expenses” (OE) component, included in the purchase cost, may now constitute up to 2% (previously 1%) of the contract price set under Incoterms CIP terms.   Priority Tasks Identified for Improving the Quality of Medical Services and Enhancing the Medical Education System On 7 May 2025, a video conference chaired by the President of Uzbekistan, Shavkat Mirziyoyev, was held to discuss issues related to improving the quality of medical services at the primary care level and specialized institutions, regulating the consumption of medicines, and enhancing the medical education system. Following the conference, a number of regulatory legal acts were adopted to implement the measures discussed at the conference. Among them are the Presidential Decree of Uzbekistan “On Measures for the Consistent Continuation of Healthcare Reform through the Improvement of the System and Principles of Medical Service Delivery to the Population in the Republic” No. UP-88 dated 19 May 2025 (the “UP №88”) and the Presidential Resolution of Uzbekistan “On Additional Measures for the Implementation of Reforms in the Healthcare System” No. PP-185 dated 19 May 2025 (the “PP №185”), which provide for measures aimed at further development of the healthcare system. According to the UP №88, inter alia, it is envisaged to introduce a new system of primary healthcare delivery, launch a new model for organizing the healthcare system as a pilot project, and increase the salaries of healthcare workers. In turn, the PP №185 sets out, inter alia, the goals and objectives aimed at implementing the pilot project, optimizing the staffing structure of the primary healthcare level, and reorganizing district healthcare institutions. Further details on the measures aimed at reforming the healthcare system are provided below. Strengthened Control of Prescription and Consumption of Medicines During the conference, it was noted that international best practices prioritize the principles of evidence-based medicine, according to which only medicines whose efficacy and safety have been confirmed by large-scale clinical trials are approved for use. At the same time, in Uzbekistan, medicines with unproven efficacy account for approximately 42% of total imports. In this regard, the President of Uzbekistan instructed the Ministry of Health to: exclude from clinical protocols medicines recognized internationally as ineffective or insufficiently studied, conduct an audit of the justification for antibiotic prescriptions in all medical institutions, with a primary focus on pediatric hospitals. Measures Approved for the Phased Implementation of Structural Changes in the Healthcare System The President addressed issues related to improving primary healthcare, disease prevention, enhancing the qualifications of medical personnel, and improving the quality of treatment. A new model for organizing the healthcare system was approved, which includes the following key measures for the phased reform of the healthcare system:   Reform of the Primary Care. The practice of concluding bilateral agreements between family medical teams and the assigned population will be introduced. Citizens will have the opportunity to freely choose their family doctor, and private medical institutions will be involved in providing medical care. The updated model of primary health care will be implemented in 2025 in the city of Samarkand, the Ishtikhan and Bulungur districts of the Samarkand region, as well as in one district of each of the other regions of the Republic. Starting from 2027, its implementation will be carried out gradually throughout the territory of Uzbekistan. It is worth noting that, in accordance with the UP №88, the implementation of the updated model of primary healthcare in the city of Samarkand, as well as in Ishtikhan and Bulungur districts of Samarkand region, has been postponed from 2025 to 2026. In execution of the UP №88, the Cabinet of Ministers of Uzbekistan adopted the Resolution “On Measures for the Implementation of the Pilot Project to Improve the Primary Healthcare System in the Republic” No. PKM-384 dated 20 June 2025 that provides for implementation of the pilot project for improving the primary healthcare system, Guaranteed Medical Care Package. Medical services and medicines included in this package will be fully covered by the state budget. These measures were subsequently reflected in the PP №185 and were further elaborated in the Resolution of the Cabinet of Ministers of Uzbekistan “On the Approval of Guaranteed Volumes of Medical Care Covered by the State Budget of the Republic of Uzbekistan in Primary Healthcare Institutions” No. PKM-382 dated 19 June 2025, Optimization of Staffing. All primary care physicians and nurses will be transferred to fulltime employment. The number of obstetrician-gynecologists in polyclinics will be doubled. A separate pediatrician position will be established for every 3,000 children, Reorganization of District Healthcare Institutions. District central polyclinics will be transformed into consultative and diagnostic departments within district hospitals, where specialized narrow-profile specialists will be concentrated. Seven large polyclinics serving more than 12,000 people will be reorganized, and 27 will be converted into smaller facilities, Increase in Salaries for Medical Workers. The base salary for a family doctor will be the equivalent of USD 500, and for a nurse — USD 300. An additional allowance of the same amount will be paid upon presentation of a qualification certificate. For active work in the mahalla (including prevention of complications, management of chronic diseases, early detection of cancer, myocardial infarction, stroke, diabetes), the salary will be further increased. The pilot implementation of this system is scheduled to begin on 1 July 2025 in 15 selected districts and cities across the regions of Uzbekistan. From 1 January 2026, this pilot project will be rolled out across the territory of the Samarkand region, Simplification of the Disability Determination Procedure. Starting from 1 June, a system for establishing disability without the involvement of medical advisory commissions will be implemented in the city of Tashkent and the Navoi region, and from 1 September – across the entire territory of Uzbekistan. Disability will be determined solely based on the conclusion of the family doctor and review by the Medical and Social Expertise Commission, Financing of Reforms. For the implementation of the new model in 15 pilot districts in 2025, UZS 285 billion has been allocated. Additionally, local authorities are required to allocate at least UZS 10 billion from local budgets. Comprehensive Measures on Modernizing Medical Care and Healthcare Financing Discussed During a conference, issues related to improving the efficiency of specialized medical care and enhancing its financing mechanisms were also discussed. Current Situation of Specialized Medical Care Reviewed A decision was made that in republican medical centers, only high-tech and complex surgical interventions will be performed, financed exclusively by the state budget. Enhancement of the “Electronic Referral” System The “electronic referral” system will be modernized. In particular: a list of diseases subject to referral through the electronic system will be approved, a unified base tariff for medical services will be established, after a referral is issued, patient information will be uploaded to a unified digital platform accessible to both public and private medical institutions, patients will have the opportunity to independently select a medical institution based on the available options. A total of UZS 1.1 trillion from the state budget is allocated for financing treatment under the electronic referral system in 2025. In this context, the digitalization of the healthcare system is reflected in the UP №88. New Five-Year Program to Combat Childhood Cancer Developed A five-year program to combat childhood cancer will be developed, similar to the existing national oncology program, with a budget allocation of at least USD 110 million. As part of the program, an academic hub specializing in the diagnosis and treatment of childhood cancer will be established at the Center for Pediatric Oncohematology. International experts and leading specialists from foreign clinics will be actively involved in its activities. In accordance with these measures discussed during the video conference, the Presidential Decree of Uzbekistan No. PP-186 dated May 19, 2025, “On Measures for the Implementation of the National Strategy of Uzbekistan on Combating Childhood Cancer for 2025–2030,” provides for the establishment of an International Academic Hub on Childhood Cancer in the form of a state institution, with the support of clinics from leading European universities. In turn, the Resolution of the Cabinet of Ministers of Uzbekistan No. PKM-326 dated May 22, 2025, “On Measures for the Organization of the Activities of the International Academic Hub on Childhood Cancer,” establishes the operational framework for the International Academic Hub’s functioning. Measures to Improve the Quality of Medical Education In order to enhance the quality of medical personnel training, the following measures were approved at the conference: Implementation of an independent knowledge assessment system for graduates of medical universities and colleges, as well as practicing doctors and nurses. For this purpose, a National Center for Medical Assessment will be established. Mandatory accreditation of all public and private medical institutions. Transfer of responsibilities for continuing medical education to public and private medical universities, specialized centers, and regional medical institutions. Introduction of dual education in the medical field. In this regard: ❖ existing clinics will be transferred under the management of medical universities, ❖ medical universities will be granted financial autonomy. Specific Instructions Regarding Regional Medical Universities: Grant financial autonomy to medical universities in the Republic of Karakalpakstan, Fergana Region, and the city of Urgench, Transfer the clinics of medical universities in the Republic of Karakalpakstan, Bukhara, Samarkand, Tashkent, Fergana Regions, and the city of Urgench into the organizational structure of the respective medical universities, Assign management of medical activities in the departments of these clinics to the relevant university faculties, Hold the rectors of the medical universities responsible for the maintenance and equipping of subordinate institutions that serve as clinical bases.   Contacts:               Zafar Vakhidov Partner, Vakhidov & Partners Uzbekistan / Kazakhstan [email protected]     Kamila Sharipova Senior Associate, Vakhidov & Partners Uzbekistan [email protected]        

On January 28, 2025, the President of the Republic of Uzbekistan (“Uzbekistan”) signed the Decree “On Additional Measures for the Accelerated Development of the Pharmaceutical Industry” No. UP13 (the “Decree No. 13”), which came into force on January 29, 2025. Below is an overview of the key regulatory changes in the pharmaceutical industry introduced by the Decree No. 13. The most significant amendments include the abolition of price markup limitations on over-the-counter medicines and the imposition of a 2% customs duty on certain categories of medicines, effective April 1, 2025. Abolition of maximum price markups on over-the-counter medicines as of April 1, 2025 Pursuant to the Decree No. 13, as of April 1, 2025, maximum price markups (15% for wholesale and 20% for retail sales) will apply only to prescription medicines. Accordingly, regulatory restrictions on price markups for over-the-counter medicines will no longer be in effect. Notably, the Decree No. 13 does not provide a clear explanation regarding the retention or removal of price markups on medical devices. Furthermore, the Decree No. 13 stipulates that the current reference pricing system shall remain in effect for domestic and imported prescription medicines, subject to the following conditions: The certification of prescription medicines is prohibited if their reference price is not indicated or exceeds the established reference price, If the same manufacturer produces medicines with an identical composition under different trade names, the lowest reference price shall apply to all such products. This rule does not apply in cases where active pharmaceutical ingredients from various manufacturers are used in the production of these medicines, The State Enterprise "Pharmaceutical Safety Center" (the "Pharmaceutical Safety Center") shall automatically adjust reference prices denominated in foreign currency without requiring the applications from businesses. If the exchange rate increases by 3%, adjustments shall be made twice a year (in January and July), and if the exchange rate increases by 5%, an unscheduled adjustment shall be carried out. Introduction of a 2% customs duty on certain categories of medicines Pursuant to the Decree No. 13, effective April 1, 2025, a 2% customs duty will be imposed on medicines classified under heading 3004 of the Foreign Economic Activity Commodity Nomenclature, based on their customs value. Furthermore, the exemption from customs duties has been extended until January 1, 2028, for technological and laboratory equipment, components, and spare parts not manufactured in Uzbekistan, as well as raw materials, substances, medical devices, and packaging used for preclinical research and medicine production, imported for own needs of pharmaceutical manufacturers and wholesale pharmaceutical trading enterprises. The relevant amendments have been introduced into the Decree No. UP-55, "On Additional Measures for the Accelerated Development of the Pharmaceutical Industry of Uzbekistan for 2022–2026," dated January 21, 2022. Requirements for the export of donor blood plasma from Uzbekistan for medicine production established Pursuant to the Decree No. 13, the proposal of the Ministry of Health and the Agency for the Development of the Pharmaceutical Industry under the Ministry of Health (the "Agency") has been approved, allowing for the export of donor blood plasma from Uzbekistan until the end of 2027 for the contractual production of medicines derived from donor blood plasma. The basis of the decision to export donor blood plasma is the conclusion issued by the Ministry of Health and the Agency. The surplus volumes of medicines produced from the exported donor blood plasma, exceeding the needs of the Ministry of Health, are allowed to be sold (exported) to foreign countries. The Ministry of Health has been instructed to submit a draft government resolution to the Cabinet of Ministers of Uzbekistan by March 1, 2025, which shall establish: The procedure for granting permission to export donor blood plasma from Uzbekistan for medicine production, The procedure for authorizing the export of medicines produced from donor blood plasma to foreign countries. Comprehensive measures adopted to stimulate the development of the pharmaceutical industry A plan for comprehensive measures has been developed to further reform the pharmaceutical industry and ensure the population's access to high-quality medicines The Decree No. 13 introduces a set of measures aimed at further reforming the pharmaceutical sector and improving the availability of high-quality medicines, including: Analysis of the application of value-added tax (VAT) on medicines and the development of proposals for improving this system by the Ministry of Economy and Finance, the Tax Committee, and the Agency, Enhancement of pharmaceutical product certification rules, including improvements to the sample identification process within certification regulations, the establishment of an appeal procedure for applicants contesting certification decisions issued by the Pharmaceutical Safety Center, improvements to the electronic certification system, increased automation of assessment processes, and the full formation of an electronic database, Development of a legal and regulatory framework for the production of biotechnological pharmaceuticals based on cell technologies, Development and submission to the Cabinet of Ministers of Uzbekistan of a draft government resolution on the establishment of a Regenerative Medicine Center, as well as measures for organizing its activities by the Ministry of Health, Provision of state medical institutions with the necessary equipment for record keeping of the medicines procured for patient treatment for reporting purposes. Approval of the Establishment of a Venture Fund and an Investment Fund for the Development of the Pharmaceutical Industry Pursuant to the Decree No. 13, the proposal of JSC "Asakabank" and the Agency to establish a venture fund under the founding ownership of JSC "Asakabank" has been approved, with a deadline set for the end of March 2025. The venture fund, to be registered in the form of a limited liability company, will have an authorized capital of USD 10 million and will finance startup projects in key pharmaceutical sectors, including biopharmaceuticals, cell technologies, and oncology research. At the same time, the Reconstruction and Development Fund, JSC "Asakabank," and the Agency are to establish the Investment Fund for Prospective Pharmaceutical Industry Projects (the "Investment Fund") under JSC "Asakabank" with no separate legal identity. The Reconstruction and Development Fund and JSC "Asakabank" will each contribute USD 50 million to the Investment Fund. The Investment Fund is authorized to participate in equity financing in applied research and investment projects within the pharmaceutical sector. The formation of the Investment Fund’s resources will be contingent upon the approval of pharmaceutical industry investment projects, with the following requirements: Feasibility studies of projects financed by the Investment Fund shall be subject to the review by the Scientific and Technical Council under the Agency, Import contracts within these projects shall be assessed by the State Unitary Enterprise "Center for Comprehensive Expertise of Projects and Import Contracts". Within two months, the Reconstruction and Development Fund, JSC "Asakabank," and the Agency are required to submit a draft Regulation on the Investment Fund for consideration by the Cabinet of Ministers of Uzbekistan. Financing Scientific Research and Startups in the Pharmaceutical Industry Pursuant to the Decree No. 13, the Ministry of Higher Education, Science, and Innovation, in cooperation with the Ministry of Economy and Finance, has been tasked with ensuring the annual allocation of up to UZS 20 billion from the State Budget to the Science and Innovation Support Fund until 2030. The allocated funds will be utilized within state programs for scientific activities, specifically for: Integrating projects into incubation and acceleration programs, Financing scientific research conducted by the Agency for Innovative Development, aimed at the development of domestic medicines, Supporting the Agency's startup projects in the pharmaceutical industry. Support Measures for Reimbursement of Registration Costs and Participation in International Exhibitions and Fairs of Domestic Pharmaceutical Manufacturers Pursuant to the Decree No. 13, the Trade Facilitation Fund is authorized to provide financial compensation to domestic pharmaceutical manufacturers based on their stability rating, as follows: 100% reimbursement of expenses related to the registration of medicines by domestic manufacturers with the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), upon submission of supporting registration documents, 50% reimbursement of expenses incurred for the registration of pharmaceutical products by domestic manufacturers in foreign countries, upon submission of supporting registration documents. Additionally, the Trade Facilitation Fund will introduce a 100% prepayment mechanism to cover the participation costs of domestic pharmaceutical enterprises in prestigious international exhibitions and fairs with exhibition stands, based on applications submitted by the Agency. Agency's Structural Unit to Provide Consulting Support to Pharmaceutical Enterprises Pursuant to the Decree No. 13, the State Enterprise "Pharm Service" is being established within the organizational structure of the Agency. The institution will specialize in providing marketing and consulting services aimed at assisting pharmaceutical enterprises in the implementation of advanced industry standards. The State Enterprise "Pharm Service" has been assigned the following core areas of activity: Supporting domestic pharmaceutical enterprises in registration of pharmaceutical products, providing legal and consulting assistance in the implementation of national and international standards, as well as offering marketing services, Facilitating the participation of domestic enterprises in prestigious international pharmaceutical exhibitions and fairs, including assistance in organizing exhibition stands, Overseeing the digitalization of the pharmaceutical industry, Providing consulting services on the design and construction of pharmaceutical enterprises. The funding sources for the State Enterprise "Pharm Service" include: Funds from the Pharmaceutical Industry Support and Development Fund, Revenue from paid services, Charitable donations from individuals and legal entities. Additional Responsibilities Assigned to the Agency and WHO Prequalification Requirement for the Pharmaceutical Safety Center Laboratory Pursuant to the Decree No. 13, the Agency has been assigned an additional responsibility — the development of the biologically active supplements and cosmetic products industry. This includes market research and analysis, product localization, and facilitating the adoption of advanced international practices and standards by industry enterprises. Additionally, under the Decree No. 13, the Ministry of Health has been instructed to ensure that the Pharmaceutical Safety Center Laboratory undergoes the World Health Organization (WHO) prequalification process by the end of 2025. This certification will confirm the laboratory’s compliance with international standards and regulations for conducting chemical and microbiological research.   Contacts:             Zafar Vakhidov Partner, Vakhidov & Partners Uzbekistan / Kazakhstan [email protected]   Kamila Sharipova Senior Associate, Vakhidov & Partners Uzbekistan [email protected]        

On July 18, 2025, by order of the Director of the National Agency for Advanced Projects  No. 3631, the Regulation on the Procedure for Carrying out Courier Service Activities in Ecommerce (hereinafter referred to as the "Regulation") was approved. The document was adopted in accordance with the Law on E-Commerce and the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan on Measures for the Further Development of the ECommerce Sector in the Republic of Uzbekistan dated December 26, 2024, No. 885, which highlights the priority of digitalizing trade and enhancing e-commerce standards in the Republic of Uzbekistan. The Regulation mainly focuses on issues of transparency, safety, and adherence to sanitary standards in goods’ delivery, especially concerning the transportation of food products. The Regulation introduces several new concepts in the sphere of courier services in ecommerce, such as the information system (IS) of the e-commerce operator, courier, delivery service operator, and delivery service.   According to the Regulation, couriers may be individuals, including self-employed persons, who provide goods delivery services under employment contracts or civil law contracts entered into with business entities, sellers, manufacturers, catering establishments, and delivery service operators.   A delivery service operator, in turn, must be a resident of the Republic of Uzbekistan who provides goods delivery services under an agreement with e-commerce operators or arranges delivery of orders to customers via couriers. Notably, unlike e-commerce operators, delivery service operators may be not only legal entities, but also individual entrepreneurs.   The Regulation sets out several key requirements for courier services in the field of ecommerce:   Mandatory ordering through the IS of the e-commerce operator. Informing the consumer of the delivery status and the expected arrival time of the courier. In particular, the terms of the delivery service (timeframes, price, methods, delivery area, etc.) must be clearly communicated to the consumer at the time of placing the order. Adherence to the principles of reliability, safety, and timeliness in the provision of delivery services. Establishment of a system for receiving and addressing consumer feedback (complaints, suggestions, etc.) related to the quality of delivery services.   When delivering food products, service providers must comply with special sanitary and hygienic standards, including the use of thermal containers.   When delivering the following food products, their separate transportation must be ensured (in separate thermal containers (thermal bags) using compartments or thermal insulation dividers) to prevent direct contact of: − raw and cooked (finished) products, − chilled, frozen, and hot foods, − food and non-food items, − products with strong odors and other goods.   In addition, the Regulation outlines the rights and responsibilities of delivery service operators, emphasizing their obligations towards couriers. The document also establishes the rights and duties of couriers in relation to both operators and consumers. These include informing the delivery service operator, meeting delivery deadlines, ensuring non-disclosure of customers’ personal data, and exercising care in handling the delivered goods.   It is noted that couriers can accept cash payments from customers for goods provided that it is stipulated in the contract with the seller or e-commerce operator. When accepting payments, couriers must comply with the requirements of applicable law, including the mandatory use of cash registers or the issuance of a receipt in either electronic or paper form.   It is important to note that the Regulation does not apply to public procurement or to transactions on the stock exchange governed by separate legislative acts.   The Regulation applies to the delivery of medicines only to the extent that it does not contradict the provisions of the Regulation on the Procedure for the Retail Sale of Medicines and Medical Products approved by Resolution of the Cabinet of Ministers of the Republic of Uzbekistan, dated April 6, 2017, No. 185 (hereinafter referred to as the "Regulation on the Retail Sale  of Medicines").   According to the Regulation on the Retail Sale of Medicines, only over the counter (OTC) medicines and medical products may be sold through e-commerce platforms within the Republic of Uzbekistan. When selling OTC medicines online, pharmacies are required to publish specific information on their websites and mobile applications, including a list of medicines and medical products subject to sale, instructions for use, prices, and information on available analogues.   In addition, special transportation conditions must be followed during the delivery of medicines. Specifically, the delivery vehicle must be technically sound and kept in proper cleanliness. During transportation, established conditions for temperature, humidity, and air circulation in the storage chamber must be strictly maintained to preserve the quality and safety of the medicines.   The present Regulation came into effect on June 21, 2025, and from that date shall apply to the activities of courier services providing delivery in the field of e-commerce.     Contacts: Zafar Vakhidov Partner, Vakhidov & Partners Uzbekistan / Kazakhstan [email protected]           Kamila Sharipova Senior Associate, Vakhidov & Partners Uzbekistan      [email protected]          

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: One of the criteria for registering the price or re-registering the registered price for wholesale and retail sale, the price within the framework of the GVFMC and/or in the OSMI system has been changed[1]. Now, the provided manufacturer's price for imported Medicines shall not exceed the average (previously maximum) value of three minimum prices from the reference countries submitted in the application and shall not exceed the average value of 3 minimum prices obtained from the data of the websites of international organizations. If the number of reference countries is less than 3, the manufacturer's price for wholesale and retail sale, within the GVFMC and/or in the OSMI system shall not exceed the average (previously maximum) value of the prices in the presented number of reference countries. At the same time, when considering prices, their minimum value is taken into account from the websites of international organizations. According to the amendments, the maximum price for an international non-proprietary name (“INN”) of a Medicine must not exceed the average (previously maximum) value of   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]. A rule has been introduced that when there’s a change in the procedure of reference pricing and price registration, the recalculation of maximum prices for trade names of Medicines for wholesale and retail sale, within the framework of the GVFMC and/or OSMI shall be carried out by National Center for Expertise of Medicines and MD (the “National Center”) without the submission of an application from the applicant, using existing data and information systems[3]. The provision has been excluded that if the re-registration of the registered price for wholesale and retail sale has not been completed between April 10 or October 10 of the current year, the National Center shall form a draft of maximum prices for the trade name of the Medicine for wholesale and retail sale based on previously approved maximum prices for the trade name of the Medicine for wholesale and retail sale[4]. Annex 5 of the Rules for Regulation of Prices for Medicines, which defines the List of basic requirements for the provision of the public service named “Registration of the Price of Medicines and MD” has been updated. MD A rule has been introduced that the revocation of registered prices for Medical Supplies shall carried out on the basis of acts of law enforcement agencies and judicial acts that have entered into legal force; and/or at the request of the applicant in no particular format[5]. A rule has been introduced that when there’s a change in the procedure for reference pricing and price registration, the recalculation of maximum prices for trade names of MD within the framework of the GVFMC and/or OSMI shall be carried out by the National Center at the initiative of an authorized body, without the submission of an application from the applicant, using existing data and information systems[6]. Annex 3 of the Rules for Regulation of Prices for MD, which establishes a list of basic requirements for the provision of the public service “Registration of the price of medicines and MD” has been updated.     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: for the period of carrying out of this procedure, but no more than 3 years from the date of filing the application in the reference state; additionally - for a period of up to 2 years in each state of recognition from the date of filing applications in these states. In this case, the application to the state of recognition must be filed no later than the date of expiration of the 3-year period from the date of filing an application in the reference state. 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: Amendments to definitions have been made (definition of the minimum reserve of Medicines and MD, definition of the component element of MD has been added)[10]; A provision has been introduced that Medicines and MD shall be purchased at prices not exceeding those established by the Order of the Acting Minister of Health of the 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]. The provision that the orphan Medicines included in the Order of the Minister of Health of the Republic of Kazakhstan dated October 20, 2020 No. ҚР ДСМ - 142/2020 "On Approval of the List of Orphan diseases and (orphan) Medicines for Their Treatment may not be registered in order to be procured has been omitted[12]. An exception has been introduced that if one domestic manufacturer (“DM”) and/or the EAEU manufacturer participates in the procurement for a lot, applications from other potential suppliers shall be automatically rejected, except for the procurement of medical equipment worth over 20 million tenge per unit, carried out through a Single Distributor (“SD”), while in this type of procurement, starting from July 31, 2025, the DM and/or the EAEU manufacturer will be provided with a conditional discount of 20% from the purchase price at the auction stage[13].     Tender A rule has been introduced that the SD carries out procurement by means of a tender[14]: 1) if purchase from domestic and foreign manufacturers has been recognized as having failed; 2) to purchase Medicines containing narcotic, psychotropic substances and precursors.   A provision on the possibility of the procurement of Medicines and/or MD in the amount of a 3-year need, on the instructions of the Ministry of Health of the Republic of Kazakhstan, has been introduced into the chapter on the procedure for carrying out a tender[15]. A rule has been introduced that upon submission of a single application for a lot which meets the terms of the announcement and the conditions of the Procurement Rules, a repeat tender shall be held[16]. New grounds have been introduced for rejecting a potential supplier's application for a lot, such as exceeding the maximum price for an INN, exceeding the maximum price of the manufacturer for the trade name of a Medicine, the maximum price for the trade name of a Medicine for retail and wholesale sale, the characteristics of the Medicine and/or Medical Supply do not correspond to the expert opinion/conclusion etc.[17]. A provision has been introduced that if a tender or any of its lots is declared as having failed, the content and terms of the tender may be changed, with the exception of the purchase of medical equipment, and the purchase may be conducted in accordance with Section 3 of the Procurement Rules. Section 3 covers tender, purchase by request for quotations from domestic or foreign manufacturers or through structural divisions of the United Nations (the “UN”), purchase from a single source, special purchase, purchase by request for quotations, purchase by concluding long-term supply contracts, etc. [18] Previously, if a tender or any of its lots was declared as having failed, the purchase was conducted in accordance with paragraph 2, Chapter 2, Section 3 of the Procurement Rules, i.e. by purchasing from a domestic or foreign manufacturer through a request for quotations[19]. A rule has been introduced that domestic manufacturers do not provide the SD with security for the fulfillment of its obligations under supply contracts concluded in accordance with Chapter 2 of Section 3 of the Procurement Rules (procurement by   requesting price quotations from domestic and foreign manufacturers or through international organizations established by the UN) [20]. There is no longer a restriction that when purchasing from a foreign manufacturer, the SD must enter into a civil law contract for a period of up to 3 years[21]. A rule has been introduced that if the purchase of Medicines and/or MD from a domestic or foreign manufacturer is declared as having failed, the SD shall conduct the purchase through a tender (previously through international organizations established by the UN) [22]. Purchase of Medical Equipment through Tender The period for reviewing applications and additions to them within a tender for the purchase of medical equipment has been extended, which now amounts to 15 working days instead of 10 working days[23]. If the customer's technical specification corresponds to only 1 model of one manufacturer from those offered by potential suppliers for the lot, then the tender or any of its lots shall be considered as having failed. An exception to this rule, which existed for the purchase of medical equipment which did not have registered analogues in the Republic of Kazakhstan, has been excluded[24]. A provision has been added stating that if a DM of medical equipment participates in the auction, the latter will be granted a conditional discount of 20% of the purchase price (current auction price), which will come into effect on July 31, 2025[25]. 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]: recognition of the purchase through tender as having failed; receipt of notification from the SD in connection with: ­ 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 A rule has been introduced that when Medicines and MD have been excluded from the list of minimum stock of the SD or the list of the SD, a reduction and/or return to the supplier of the purchased volume of minimum stock of Medicines and MD shall be permitted[32]. Medicines and MD of the minimum stock are replenished by the SD in the ways provided for in Chapters 1, 2 and 3 of Section 3 of the Procurement Rules (taking into account the remaining Medicines and MD) namely by tender, request for price quotations from domestic and foreign manufacturers or through international organizations established by the UN, from a single source (previously only by tender and from a single source)[33]. Amendments were also introduced to the annexes to the Procurement Rules, namely: Annex 5 “Standard contract for the purchase of goods (between the customer and the supplier)”; Annex 7 “Application for issuing a conclusion on the compliance of characteristics with the technical specifications for the purchase of medical equipment”; Annex 8 “Conclusion on the compliance of characteristics with the technical specifications for the purchase of medical equipment”; Annex 9 “Application for the purchase of medical equipment”; Annex 11 “Agreement for the purchase of Medicines and/or MD (between the SD and a customer)”; Annex 12 “Standard contract for the purchase of Medicines and/or MD (between the SD and a customer)”; Annex 13 “Standard gratuitous contract for the supply of Medicines and/or MD for outpatient Medicine provision. Standard gratuitous contract for the provision of pharmaceutical services”; Annex 15 “Technical specifications for the tender application of a potential supplier”; Annex 17 “Standard supply agreement dated ______________ No. _________ (between the SD and a supplier)”; Annex 23 “Model Supplementary Agreement No. to the Model Long-Term Contract for the Supply of Medicines and MD dated ________ year No. ______________ (between the SD and a supplier).” The following new annexes have been added: Annex 9-1 “Information on medical equipment worth over 20,000,000 tenge”; Annex 9-2 “Information for __________ year based on monitoring of the purchase of medical equipment”. 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;