Uzbekistan

What is a clinical trial? Clinical trials ("CT") of pharmacological products ("PP") or medicinal products ("MP") are defined as studies involving human subjects conducted to investigate the pharmacological properties, side effects, and interactions with other MP in order to determine the safety and efficiency of MP/PP. What types of CTs can be conducted in the Republic of Uzbekistan ("Uzbekistan")?  CT of MP/PP may be conducted in a single medical and preventive institution ("Clinical Base") or according to a single protocol in the form of a multicenter (interventional) CT in more than one Clinical Base. In Uzbekistan, the main legal acts regulating CTs are: Law of Uzbekistan "On Medicines and Pharmaceutical Activities" dated January 4, 2016, No. 399 It regulates the basic requirements for CT. Resolution of the Cabinet of Ministers of Uzbekistan "On Measures to Develop CTs of MPs and Organize their Conduct in Accordance with International Standards" dated April 14, 2022, No. 181 The resolution defines the legal basis for the organization of the State Enterprise "Center for CT Development" ("Center")and describes its main responsibilities. Order of the Minister of Health of Uzbekistan on the Approval of the Regulation "On the Procedure for Conducting CT of MP/PP" dated June 5, 2023, No. 3439 It defines the legal basis for regulating and conducting CT of MP/PP within the framework of state registration of MP/PP. It should be noted that, in the absence of a regulatory act governing the conduct of independent CT, this ministerial order also applies to the independent CTs, carried out outside the framework of state registration of MP/PP. Key Regulatory Bodies Ministry of Health of Uzbekistan ("MH") approves the CT of MP/PP on humans, approves the procedure for conducting CT of MP/PP and the list of Clinical Bases where CT are conducted. Pharmaceutical Industry Development Agency organizes the examination of the results of preclinical trials and CT of MP/PP and medical devices ("MD"), ensures the state registration, quality control, standardization, and certification of MP/PP, MD, and medical equipment. organization of CT of MP/PP in accordance with the requirements of Good Clinical Practice (GCP), determination of the pharmacological bioequivalence of generic MP to original MP, conducting pharmacokinetic studies of MP/PP in CT subjects, improving the qualifications of medical workers in the field of conducting CT, International cooperation in the field of Good Clinical Practice (GCP). Pharmacology Committee ("PC") at the Center The structural subdivision of the Center responsible for issues related to CT of MP/PP. Clinical Base  Medical and preventive institutions that can perform CT of MP/PP  included in the list approved by the MH. Ethics Committee (the "Committee") A permanent collegial body operating on a voluntary basis, approved by the MH and consisting of representatives of medical and research organizations, higher education institutions, the media, non-governmental non-profit organizations, and other civil society institutions. The Committee conducts ethical reviews of the ethical validity of CT. Board of Experts (the "Board") decides whether to approve or reject the use of MP/PP in medical practice. Is notification/permission required to conduct CT in Uzbekistan? As part of the state registration of MP/PP, based on the recommendation of the PC, the Board shall, within one working day of receiving the relevant recommendation, decide on the conduct of a CT. Within one working day of the decision being made by the Board of PC, the applicant will receive a notification via the electronic system indicating the possibility of conducting a CT. With regard to conducting independent CT of MP/PP on humans in Uzbekistan, it is mandatory to obtain permission from the MH. However, there are no specific regulations or procedures for obtaining such permission in the current legislation. MH, which reviews the application in accordance with international ICH GCP standards for issuing a CT permit. After approval by the MH, the applicant submits the documents to the Center, where the request is reviewed in accordance with internal rules. The procedure applies to applications from individuals and legal entities and does not constitute a procedure for conducting independent CT due to the lack of legal grounds. What are the requirements for participating in the CT? Obtaining a written consent:A subject may be included in a CT only if he or she or his or her legal representative has received information regarding the nature and possible consequences of the CT, the properties of the MP/PP, its expected efficacy, and the degree of risk, and has given his or her Consent to participate in the CT. Restrictions on participation in CTs for certain categories of persons. In cases where the CT is conducted with the participation of a minor or incapacitated person, the consent of their legal representative must be obtained prior to the commencement of the CT. Requirements for Clinical Bases Conducting CT. The Clinical Base included in the list approved by the MH must have a legal address, seal, and bank account with the Republic of Uzbekistan. Material resources (laboratory and diagnostic equipment, instruments, tools, etc.) that enable the effectiveness and safety of the tested product to be assessed in accordance with international standards. High scientific qualifications of the Clinical Base's staff. Existence of an ethics committee. Result of Conducting CT Upon completion of a CT, an applicant is issued individual registration forms and CT’s subject consent forms signed by the CT director and research physicians. Based on the results of the CT, a CT report is compiled. The CT report is approved by the director of the Clinical Base and is submitted to the applicant. The CT report for state registration of MP/PP submitted by the applicant is sent for final review by the PC within 15 days. The review is conducted to verify that the CTs conducted comply with the approved protocol. If there are no discrepancies between the report and the CT protocol, the results of the final review are sent to the Board. With regard to an independent CT, in the absence of a separate procedure after completing the CT, the Center issues a report to the applicant based on the Center's internal rules, similar to the procedure described above. Next, the PC conducts a final review of the CT in accordance with the approved CT protocol.

Commerce Legislation News Uzbekistan – November  2025 The regulatory framework governing trade activities in the Republic of Uzbekistan (hereinafter referred to as “Uzbekistan”) has undergone significant amendments designed to strengthen consumer protection mechanisms. Below is an overview of the key developments. The Government has approved new regulations governing promotional campaigns and discounts in retail trade. By Resolution of the Cabinet of Ministers of Uzbekistan No. 662 dated October 21, 2025 (hereinafter referred to as the “Resolution No. 662”), amendments and additions have been introduced to a number of regulatory acts, including the Rules of Retail Trade of Uzbekistan approved by Resolution No. 75 dated February 13, 2003 (hereinafter referred to as the “Trade Rules”). The draft of the new procedure for regulating promotional campaigns and discounts in retail trade was initiated by the Competition Promotion and Consumer Protection Committee (hereinafter referred to as the “Competition Committee”) in July 2025. Under the amendments, Clause 3 of the Trade Rules is supplemented with the following new definitions: Promotional Campaign –  advertising in the form of an event, contest, or game that encourages consumers to take certain actions, including participation conditioned upon receiving the advertised product; Price List – information indicating the final price set for a unit of goods or a specific quantity of goods, typically offered to the consumer without any conditions, in a single copy and clearly stated; Discount Price – a price at which the cost of goods is reduced by a certain percentage or amount from its pre-discount price; Pre-Discount Price – the lowest price set for a unit of goods, typically offered to the consumer within 30 days prior to the announcement of the discount price, which must be confirmed by the seller. In addition, the Trade Rules have been supplemented with a new Chapter XVII⁴ governing the regulation of promotional campaigns and discounts. Under the new requirements, when applying a discount to the price of goods, the seller must: Indicate the pre-discount price (except for agricultural products). Failure to do so will be deemed a price reduction rather than a discount; Avoid artificially inflating prices prior to announcing discounts; Maintain records of goods and prices, including price history for the last 30 days, and provide this information to consumers upon request. Furthermore, when announcing a promotional campaign, the seller is required to: Clearly and transparently communicate its terms to consumers, including duration, list of goods, quantities, and purchase conditions; Refrain from altering the terms of the campaign after its announcement or providing misleading information; Ensure actual compliance with all declared discounts, bonuses, and benefits under the campaign; Maintain sufficient stock of goods included in the campaign for its entire duration. In addition, retailers should also take into account the following requirements: When conducting a promotional campaign in the form of a mass event, the established procedures must be observed, and prior authorization must be obtained from the internal affairs authorities; When processing personal data of campaign participants, compliance with personal data legislation is mandatory, and consumers must be informed of the purposes and conditions of data processing. The Government has approved regulations on prescription medicines and abolished price controls for over-the-counter medicines and medical devices. The Resolution No. 662 also introduces amendments to Cabinet of Ministers Resolution No. 185 dated April 6, 2017, “On Measures to Implement the Law of the Republic of Uzbekistan dated January 4, 2016, No. 399 ‘On Amendments and Additions to the Law of the Republic of Uzbekistan ‘On Medicinal Products and Pharmaceutical Activity’” (hereinafter referred to as the “Resolution No. 185”). Under the amendments, the scope of price regulation has been narrowed. Price controls now apply exclusively to prescription medicines in both wholesale and retail sales. All previous references to “medicines and medical devices” have been replaced with “prescription medicines.” Accordingly, references to medical devices have been removed, and the mechanism for determining prices for imported prescription medicines has been clarified. Restrictions on trade mark-ups for Prescription Medicines remain in force. In addition, wholesale and retail prices for Prescription Medicines must not exceed the established reference price limits. Another significant change is the transfer of control functions for compliance with legislation governing wholesale and retail sales of medicines from the previously authorized body, the Agency for the Development of the Pharmaceutical Industry under the Ministry of Health of the Republic of Uzbekistan, to the state institution “Center for Pharmaceutical Product Safety.” The President introduces measures to strengthen liability for selling expired or improperly labeled food products On October 6, 2025, the President of the Republic of Uzbekistan, Shavkat Mirziyoyev, signed Resolution No. 296 (hereinafter referred to as the “Resolution No. 296”), which provides for enhanced control over the quality and safety of food products and the implementation of modern mechanisms for consumer protection. Under the Resolution No.296, starting March 1, 2026, the sale of expired products will be restricted through the digital labeling system “Asl Belgisi.” Cash register systems will not allow receipts to be issued for products past their expiration date. Currently, labeling requirements apply to tobacco and alcohol products, medicines, water and beverages, mineral fertilizers and chemicals, among others. In addition, from October 15, 2025, to January 1, 2027, a pilot procedure will be introduced under which consumer complaints and test purchases will be handled by non-governmental non-profit organizations (hereinafter referred to as “NGOs”). Employees of such NGOs must hold a special certificate confirming completion of training courses at the Center for Research on Competition Policy and Consumer Rights under the Competition Committee. The Resolution No.296 also approves the Competition Committee’s proposal to strengthen administrative liability for the sale of food products: with expired shelf life; without indication of the production date and/or expiration date, where such labeling is mandatory. Previously, Article 178 of the Administrative Liability Code of Uzbekistan provided for fines ranging from 3 to 10 BRV (approximately UZS 1.2–4.2 million) for individuals and 7 to 10 BRV (approximately UZS 2.8–4.2 million) for officials. Following the amendments, the upper limit of the fine for both individuals and officials will be 30 BRV (approximately UZS 12.3 million). To facilitate the submission of consumer complaints and enable prompt responses, the Competition Committee will launch the “Consumer Complaint” information system on December 1, 2025. This platform will allow monitoring of complaint handling at all stages. The system will be integrated with the personal account of the Tax Committee, enabling entrepreneurs to receive real-time notifications of consumer complaints. Under the new procedure: Initial review of complaints must be carried out by entrepreneurs within 10 calendar days, under the supervision of the Competition Committee; If the entrepreneur fails to remedy the violation or provide a reasoned response, the complainant may: submit the complaint to the Competition Committee; or contact a consumer protection organization. If the entrepreneur does not eliminate the violation within 10 days, the organization may, through the system, escalate the complaint to the Competition Committee or file a claim in court.

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]