Uzbekistan

Significant changes have been made to the regulation of state registration of medicinal products (hereinafter - "Medicines") and medical devices (hereinafter - "MDs") in the Republic of Uzbekistan (hereinafter - "Uzbekistan") with a view to simplifying the state registration of Medicine and MD. An overview of the key changes is provided below. Resolution No. 738 of the Cabinet of Ministers of Uzbekistan dated November 24, 2025, approved new Regulations "On the Procedure for State Registration of Medicines" (hereinafter referred to as the "Regulation-1") and "On the Procedure for State Registration of MDs" (hereinafter – the "Regulation-2"). These documents provide for the procedure for state registration of Medicines and MDs, the issuance of certificates, as well as their extension and cancellation. In addition, Resolution No. 738 repeals the Resolution No. 213 of the Cabinet of Ministers of Uzbekistan dated March 23, 2018, "On Approval of the Regulations on the Procedure for State Registration of Medicines, MDs and Medical Equipment and Issuance of Registration Certificates" (hereinafter referred to as the "Resolution No. 213"). Resolution No. 738 was adopted in pursuance of the Decree of the President of Uzbekistan "On Additional Measures to Regulate the Circulation of Medicines and MDs" No. UP-137 dated August 19, 2025, which strengthens the role of the Center for Pharmaceutical Products Safety" (hereinafter – the "Centre") under the Ministry of Health (hereinafter – the "MH") of Uzbekistan. Regulation 1 and Regulation 2 shall enter into force on 26 February 2026. I. Regulation on the procedure for state registration of Medicines Scope, concepts and scope of registration The Regulation-1 defines the procedure for state registration of all Medicines – original, generic, biosimilar, biotechnological and others – and applies to developers, manufacturers, registration certificate holders and their authorized representatives. The following basic terms are described in detail below. Generic Medicine is a Medicine that has the same qualitative and quantitative composition and dosage form as the active substance of the original (patented) Medicine, but is manufactured after the expiry of the patent, and whose safety, potency, properties, area of application and bioequivalence have been confirmed in relation to the original Medicine. Different salts, esters, isomers, mixtures of isomers, complexes or derivatives of the active substances are recognized as the same active substance if they do not differ significantly in terms of safety and efficacy. Different dosage forms intended for oral administration and having a rapidly released active substance are recognized as the same dosage form in bioavailability studies. Biosimilar Medicine is a biological Medicine obtained from natural sources, containing the active substance of a registered original (reference) Medicine and proven to be similar to the original (reference) Medicine in terms of quality, biological activity, efficacy and safety based on comparative studies. Original Medicine is a Medicine containing a new active substance or substances, registered first on the global pharmaceutical market, the quality, efficacy and safety of which are confirmed by the results of preclinical and clinical trials (hereinafter - "CTs"). Technology Transfer is the transfer of technological processes, data and experience in the development and/or production of Medicines, including from one pharmaceutical organization to the production site of another pharmaceutical organization without changing the qualitative and quantitative composition of the Medicines, apart from "in bulk" products. Contract Manufacturing is manufacture of registered Medicines by one pharmaceutical organization on a contract basis for another pharmaceutical organization without changing the technologies at its facilities. Pharmaceutical Organization is an authorized legal entity responsible for the safety, quality and efficacy of Medicines, which is the developer, manufacturer or purchaser of Medicine. Notably, biotechnological Medicines have been added to clause 5 of the Regulation‑1, defined as those produced on the basis of cell technology, previously registered in Uzbekistan, with changes to their type (autologous, allogeneic, combined), qualitative and/or quantitative composition (excluding the composition of excipients), as well as the biological and other properties of the cell line(s). According to clause 3 of the Regulation-1, the registration of Medicines is carried out in two ways: In the general procedure, Through recognition, whereby Medicines, registered by the following foreign organizations, undergo state registration in Uzbekistan by means of recognition: Regulatory authorities included in the World Health Organization (WHO) Listed Authorities. Regulatory authorities with Maturity Level 4 according to the World Health Organization’s Global Benchmarking Tool. For the following Medicines, state registration will now not be required in accordance with clause 7 of the Regulation-1: radiopharmaceutical Medicines manufactured directly in medical institutions, Medicines intended for export, bone marrow stem cells, biotechnology products based on cell technology, specially manufactured and used in a medical institution for individual patients for the purpose of fulfilling an individual medical prescription. At the same time, at the request of the applicant, substances used to produce Medicines intended for export may be registered. In addition, according to clause 8 of the Regulation-1, the import of orphan Medicines, imported Medicines used in the prevention, diagnosis and treatment of particularly dangerous infections, as well as infections posing an epidemiological risk, at the request of the MH of Uzbekistan, may be carried out without state registration. Medicines imported as foreign gratuitous and humanitarian aid may also be imported into the territory of Uzbekistan and used without state registration upon receipt of a positive conclusion from the MH on the import and use of these Medicine in the territory of Uzbekistan.  A priority registration procedure is introduced for the following Medicines: Medicines registered in Uzbekistan that have no analogues, orphan Medicines, Medicines in high demand on the domestic market based on the requirements of the MH of Uzbekistan, the first analogue of the original Medicines. Requirements and conditions, GMP/GVP An applicant who releases Medicines into circulation based on a registration certificate shall additionally be obliged to: ensure the accuracy and reliability of information in registration files and guarantee the quality, safety and efficacy of Medicines, regularly submit information on side effects to the Centre, ensure that Medicines are placed on the market in Uzbekistan for at least three years after their state registration (except for Medicines manufactured by domestic manufacturers for export). Documents and samples required for registration The following official documents obtained from abroad must be apostilled or legalized at the Consulate of Uzbekistan abroad: Certificate of registration and/or certificate of pharmaceutical products (CPP) in accordance with WHO recommendations, issued by authorized bodies, international or foreign organizations for foreign manufacturers, Certificate of compliance with the requirements of the Good Manufacturing Practice (GMP) standard and a report on the results of the last inspection (for foreign manufacturers), License for the manufacture of Medicine. The authorized representative of the applicant must have a higher education degree in pharmacy, medicine, chemistry or biology. Expert review, deadlines and Medicines registration A fee will be charged for reviewing the application, which will not be refundable if the applicant withdraws the application and the Medicine registration is refused. Applications will be reviewed within the following timeframes: for vaccines - 30 days. for medicinal substances (substances) - 45 days. for Medicines registered under the general procedure - 210 days.  These timeframes do not include 45 days allocated for the elimination of deficiencies identified as a result of the initial examination; 90 days allocated for the elimination of deficiencies identified as a result of a specialized examination; CTs periods (up to 1 year for generics, up to 3 years for original Medicines) and the time spent on verifying compliance with the GMP standard. Changes in the Medicine registration procedure: An expert opinion will be issued based on the results of the initial examination of registration documents and Medicine samples. Specialized examination: Laboratory test reports and documents will be examined for compliance with registration requirements and conditions based on the substantiated conclusions of scientific commissions consisting of independent experts. Conducting CT and examining their results: The Centre will issue a conclusion on the registration of Medicine with or without CTs. Conducting CT during Medicines registration will not be required for medicinal substances (substances), biotechnological Medicines produced on the basis of cell technology, obtained as a result of processing human cells without significant changes, and oral generics whose bioequivalence to the reference product has been proven using validated in vivo or in vitro research methods, the results of which are presented in the form of quantitative indicators. The need for inspections of bioequivalence studies to assess compliance with GCP requirements will be determined based on the following criteria: submission of unjustified data on the results of bioequivalence studies, inconsistency of the identified values specifically for this active substance, unreliability of one of the clinical, statistical or analytical data presented, obtaining results in pharmacokinetic studies that do not confirm bioequivalence. From 1 January 2029, bioequivalence studies of oral generics based on ICH requirements will become mandatory. Based on the results of the registration review of the Medicine, the Centre will make one of the following decisions: to register the Medicine, to refuse to register the Medicine. Validity period of the registration certificate, changes and register The registration certificate will be issued to all for a period of 5 years. II. Regulations on the procedure for state registration of MDs Scope and risk classes MD will be registered in accordance with the new the Regulation-2. MD will now be registered according to the following safety levels: Class I - MDs with low risk, Class IIa - MD swith medium risk, Class IIb - high-risk MDs, Class III - MDs with the highest risk level. According to clause 4 of the Regulation-2, MD registration will be carried out in two ways: In the general procedure, Through the recognition procedure. MDs registered by the following foreign organizations will undergo state registration in Uzbekistan through recognition: Food and Drug Administration (FDA), USA, Authorities authorized to issue the European Certificate of Conformity (CE), European Union, European Medicines Agency (EMA), European Union, Pharmaceuticals and MD Agency (PMDA), Japan, Ministry of Food and Drug Safety (MFDS), Republic of Korea, Medicine and Healthcare Products Regulatory Agency (MHRA), United Kingdom. According to clause 5 of the Regulation-2, registration is no longer required for: reagents included in the kit for in vitro diagnostic MDs that cannot be used as a diagnostic tool on their own, MDs manufactured based on individual order. MDs intended for export may be registered in Uzbekistan at the request of the applicant. The import of MDs used in the diagnosis and treatment of orphan diseases and used in the prevention, diagnosis and treatment of particularly dangerous infections, as well as infections posing an epidemiological risk, imported at the request of the MH of Uzbekistan, may be carried out without state registration of the imported MDs. MDs imported as foreign gratuitous assistance, and humanitarian aid may be imported into the territory of Uzbekistan and used without state registration. In this case, the MH of Uzbekistan must issue a corresponding positive conclusion for the import into the territory of Uzbekistan and use of these MDs. Documents, examination, and deadlines Now, if the applicant withdraws the application and registration of the MD is refused, the fee paid for consideration is not refundable. Applications for the state registration will be considered by the Centre within the following timeframes: within 30 working days - MDs for in vitro diagnostics used during epidemics and pandemics of infections posing an epidemiological threat, registered once a year, within 60 working days - MDs classified as Class I according to the safety classification, within 90 working days - MDs classified as Class IIa according to the safety classification, within 120 working days - MDs classified as Class IIb and Class III in the safety classification. These periods shall not include 30 days allocated for the elimination of deficiencies in the event of refusal to accept the application; 60 days allocated for the elimination of deficiencies identified as a result of a specialized examination; the period of the CTs and the time spent on checking the MDs for compliance with the requirements of the national standard of Uzbekistan, harmonized with the international standard "ISO: 13485". Changes in the procedure for registering MDs: Laboratory tests: Laboratory tests for MD and their components registered through recognition and MDs of class I according to the safety classification (except for sterile, measuring and invasive MDs) will not be conducted. Specialized expertise: Laboratory test reports and documents on compliance with registration requirements and conditions will be reviewed based on reasoned conclusions of scientific commissions consisting of independent experts. Conducting CTs and reviewing their results: Conducting a CT during registration will not be required for Class I MDs according to the safety classification and for in vitro diagnostic MDs prequalified by the WHO and registered in cooperation with the WHO. Inspection of manufacturing conditions: Production facilities will be inspected on site. The inspection will cover the quality management system, product traceability system and production environment. Inspections will be carried out in accordance with the national standard of Uzbekistan, harmonized with the international standard "ISO:13485". Based on the results of the inspection, the facilities are subject to certification in accordance with the established procedure. Inspections of the production conditions of MDs not manufactured in Uzbekistan will be carried out on a priority basis, apart from the following: MDs registered by recognition, MDs for in vitro diagnostics, prequalified by the WHO and registered in cooperation with the WHO, MDs with a valid certificate in accordance with the requirements of the national standard of Uzbekistan, harmonized with the international standard "ISO: 13485".   Registration certificate and register Based on the results of state registration, a corresponding registration certificate will be issued for 5 years. Contacts: Zafar Vakhidov Partner, Vakhidov & Partners Uzbekistan / Kazakhstan [email protected]         Kamila Sharipova   Senior Associate, Vakhidov & Partners Uzbekistan [email protected]      

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]