Vakhidov & Partners

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]        

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;

On August 21, 2025, Decree No. UP-142 of the President of the Republic of Uzbekistan ‘On Measures to Improve the Regulatory System in the Field of Telecommunications’ (the “Decree 142”) was adopted. The Decree was adopted in pursuance of the Law of the Republic of Uzbekistan ‘On Telecommunications’ dated December 27, 2024, No. ZRU-1015 (the “Telecommunications Law”) and is aimed at improving state management in the telecommunications sector through the creation of the Telecommunications Regulatory Agency (the “Agency”). Decree 142 came into force on August 23, 2025. Pursuant to Decree 142 and Articles 9 and 11 of the Telecommunications Law, the Agency has been assigned the functions of a regulatory authority in the field of telecommunications. The Agency was established as a republican executive body and reports to the Cabinet of Ministers of the Republic of Uzbekistan (“Uzbekistan”). In 2025, the Agency's activities will be financed by the Digital Technology Development Fund (the “Fund”), and from 2026 onwards by the State Budget, five per cent of the revenue from state fees for issuing licenses for the right to operate in the telecommunications sector, which is allocated to the Fund, and other sources not prohibited by law.   It should also be noted that on August 29, 2025, in pursuance of the Decree, the Cabinet of Ministers of Uzbekistan adopted Resolution No. 550 “On Measures to Organize the Activities of the Telecommunications Regulatory Agency of Uzbekistan’ No. 550, which approves the Regulations ‘On the Telecommunications Regulatory Agency of Uzbekistan” (the “Regulation about Agency”). The Regulation about the Agency details the Agency's functions through which it implements its tasks set out above. Below is a list of the main functions that affect a wide range of entrepreneurs and consumers and contribute to the development of competition in the telecom market of Uzbekistan: Regulation of tariffs for certain types of telecommunications services, telecommunications, and internetwork connection services regulates tariffs for certain types of telecommunications services, as well as internetwork connection, establishes a list and requirements to the quality of universal services and regulates tariffs for them, considering the interests of users, regulates tariffs on certain types of communication services, as well as on internetwork connection, approves the procedure and conditions for connecting telecommunications networks, the provision of mutual services by operators and the settlement of accounts between them. ➢ Licensing and expertise licenses legal entities operating in the telecommunications sector in accordance with established procedures and monitors licensees' compliance with licensing requirements and conditions, accredits legal entities that conduct expert reviews of design and estimate documentation for the construction of telecommunications networks and telecommunications facilities. Developing competition and creating proportionate opportunities promotes the creation of a fair and equitable competitive environment for the operation of telecommunications operators and providers, promotes the formation and development of a telecommunications services market based on free competition. Issues relating to user rights, quality and control of telecommunications services participates in the consideration of issues related to the protection of the rights and legitimate interests of users, relations between operators, providers and users, monitors the quality of telecommunications services provided by operators and providers through the Uzbekistan telecommunications network monitoring system for compliance with established requirements. Development and approval of procedures for using the address space of the national segment of the global Internet information network, as well as determining the domain name system develops and approves the procedure for using the address space of the national segment of the global Internet information network in agreement with the Ministry of Digital Technologies Uzbekistan (the “Ministry”) and interested organizations, determines the domain name system, develops the national domain zone and creates favorable conditions for its promotion, carries out mandatory digital marking of telecommunications equipment, determines the list of universal services and requirements for their quality and regulates tariffs for them in accordance with the procedure established by law, taking into account the interests of users.   Access to International Networks Liberalized The Cabinet of Ministers of Uzbekistan also adopted Resolution No. 592 of  September 18, 2025, ‘On the phased liberalization of the telecommunications market and additional measures to create a competitive market’ (the “Resolution 592”) in pursuance of Decree No. 85 dated June 3, 2024, of the President of Uzbekistan ‘On further measures to accelerate market reforms and bring national legislation into line with World Trade Organization agreements’. The Resolution 592 states that from January 1, 2025, telecommunications operators with mobile and/or wired telecommunications networks operating in Uzbekistan as an experiment, will be granted the right to connect directly to international Internet networks for their own commercial needs, in full compliance with the requirements of operational and investigative activities, information and cyber security systems. The State Unitary Enterprise ‘Republican Centre for Telecommunications Network Management of Uzbekistan’ (the “Working Body”) under the is responsible for the direct connection of telecommunications operators to international Internet networks.   To join this experiment, telecommunications network operators must comply with the temporary requirements and conditions of the Appendix to Resolution 592: organize centers for connection to the Internet (the “Centers”), ensure that at least 50% of the population throughout Uzbekistan, including in remote and hard-to-reach areas, is covered by fiber-optic backbone networks, and have the infrastructure to provide the population with broadband telecommunications services, provide the Working Body with the necessary design and other documents, comply with the requirements for employees of the Centers: the head and chief engineer of the center must be citizens of Uzbekistan, the nomenclature of important positions at the Center must be agreed with the Working Body, etc.), comply with the requirements for cooperation with authorized state bodies (the Ministry, State Security Service, Centre for the Development of Electronic Technologies and the State Unitary Enterprise “Centre for Cyber Security”), comply with certain technical requirements for telecommunications network operators. Contacts:  Zafar Vakhidov   Partner, Vakhidov & Partners      Uzbekistan / Kazakhstan  [email protected]      Kamila Sharipova                                                    Senior Associate, Vakhidov & Partners      Uzbekistan [email protected]

    Legislative Updates in E-Commerce Uzbekistan – January 2025   New Initiatives for the Advancement of E-Commerce in Uzbekistan On December 26, 2024, the Cabinet of Ministers of the Republic of Uzbekistan (“Uzbekistan”) adopted Resolution No. 885 "On Measures for the Further Development with the sphere E-Commerce in the Republic of Uzbekistan" (the "Regulation No. 885"). Below is an overview of the key regulatory innovations in e-commerce introduced by the Regulation No. 885. Conditions for Recognizing E-Commerce Operators in Uzbekistan have been established According to the Regulation No. 885, only legal entities that are residents of Uzbekistan can qualify as e-commerce operators (including electronic trading platforms, order aggregators, and digital streaming service providers). Meanwhile, legal entities and/or individual entrepreneurs who do not assume obligations under electronic contracts or transactions and are limited to providing information about goods (works, services) and digital products through their informational resources or platforms are not considered e-commerce operators. New Conditions and Requirements for E-Commerce Operators will be Introduced starting from July 1, 2025 According to the Regulation No. 885, starting from July 1, 2025, e-commerce operators must adhere to a notification-based regulatory framework, which includes the following conditions and requirements: Register as a legal entity within Uzbekistan, Comply with the applicable legislation of Uzbekistan in the fields of e-commerce, personal data protection, copyright, consumer rights, advertising, and other regulatory legal acts, Provide information related to their activities in the field of e-commerce to the authorized body upon request and free of charge, Comply with the retail trade regulations in force within Uzbekistan, Ensure the availability of an information system that guarantees the required level of functionality for providing services to e-commerce participants, Ensure the accuracy of the information contained in the notification of the commencement of activities, Ensure mandatory registration of information regarding new employment contracts, amendments to existing contracts, terminations, and details of active employment contracts in the interdepartmental software and hardware complex “Unified National Labor System,” if required for performing relevant employee-related actions. Comply with other requirements and conditions, considering the specific nature of the activities carried out under the notification procedure. In addition, according to the Regulation No. 885, starting from July 1, 2025, legal entities, individual entrepreneurs, and self-employed individuals engaged in e-commerce will be subject to the following requirements: Legal entities, individual entrepreneurs, and self-employed individuals engaged in the sale of goods, provision of services, or passenger transportation through electronic platforms are now required to use separate bank accounts for all financial transactions, The income generated by self-employed individuals in the field of e-commerce must be credited to a specially designated bank account. A bank card linked to this account shall be used to track incoming funds. Funds credited to this account will be included in the calculation of revenue for goods and services sold. Based on this data, self-employed individuals will be recognized as turnover taxpayers. Special Conditions for Legal Entities, Entrepreneurs, and Self-Employed Individuals As an exception, the Regulation No. 885 permits self-employed individuals engaged in the delivery of goods (works, services) or passenger transportation by light motor vehicles to: Pre-deposit funds into specially designated bank accounts of self-employed individuals, with subsequent debiting in favor of suppliers of goods (works, services) or e-commerce entities, Accept cash payments for delivered goods (works, services). In this case, it is permissible for self-employed individuals to retain cash in an amount equivalent to the amount transferred to the supplier of goods (services) from the separate bank account, without mandatory cash collection. When exporting goods via electronic trading platforms, legal entities, individual entrepreneurs, and self-employed individuals are allowed to send goods sold online to foreign buyers through courier and postal services, including without registering contracts in the Unified Electronic Information System for Foreign Trade Operations. Note: Additionally, electronic trading platforms are required to ensure the integration of their systems with the information resources of the State Tax Committee of Uzbekistan and the Customs Committee under the Ministry of Economy and Finance of Uzbekistan. Instructions on Improving E-Commerce Regulation and Implementing Control Mechanisms In accordance with the Regulation No. 885, the Statistics Agency of Uzbekistan, in collaboration with the National Agency for Perspective Projects (the “NAPP”) and with the support of foreign experts, has been tasked with introducing reporting forms for e-commerce entities by July 1, 2025, based on international best practices. In addition, within the context of fulfilling the requirements of the Regulation No. 885, the NAPP is required to undertake the following actions within three months: Develop and approve the procedure for conducting courier activities in the field of e-commerce, In collaboration with the Committee for Competition Development and Consumer Rights Protection develop mechanisms for online dispute resolution within the realm of electronic commerce in Uzbekistan and present the corresponding proposals to the Cabinet of Ministers. In collaboration with other authorized ministries and agencies, develop and submit draft regulatory legal acts to the Cabinet of Ministers. These proposals should introduce new concepts and terms into e-commerce legislation and provide for the implementation of the notification procedure for e-commerce operators in accordance with the conditions and requirements mentioned above. Additionally, the establishment of a register of e-commerce entities is planned.

On October 4, 2024, the Cabinet of Ministers of the Republic of Uzbekistan adopted Resolution No. 628, titled "On the approval of the Regulation on the Procedure for Conducting Post-marketing Surveillance of Pharmaceutical Products" (the "Regulation No. 628"), which came into effect on October 5, 2024. According to Regulation No. 628, post-marketing surveillance is conducted by the Pharmaceutical Product Safety Center under the Ministry of Health of the Republic of Uzbekistan (the “Center”) without interfering in the financial and economic activities of business entities." Procedure for introducing pharmaceutical products into circulation Pursuant to Regulation No. 628, medicines, medical purpose devices, and medical equipment ("MPDs, and ME") manufactured by enterprises that do not possess a valid certificate of conformity may be placed into circulation only after the authorized representative of the enterprise enters information regarding the relevant batch, name, pharmaceutical form, international nonproprietary name (INN), quantity, prices, and production date into a special electronic system maintained by the Center, or in paper form. The responsibility for the accuracy of the provided information rests with the manufacturer. Grounds and procedures for conducting post-marketing surveillance The grounds for conducting post-marketing surveillance include: A post-marketing surveillance plan approved monthly by the head of the Center, Receipt of information and complaints from individuals and legal entities, including governmental bodies and organizations, concerning the quality, safety, illegal circulation, and side effects of pharmaceutical products, Information from mass media and the results of public opinion surveys utilizing information and communication technologies. The Center develops the post-marketing surveillance plan based on a protocol with respect to identified samples once a month. This plan is approved by an order of the head of the Center by the 25th of each month. If information regarding the quality, safety, illicit trafficking, or adverse effects of pharmaceutical products is received from individuals, legal entities, government bodies and organizations, mass media, and information and communication technologies, the head of the Center shall within one business day issue an order for the implementation of post-marketing surveillance. To carry out post-marketing surveillance, the Center procures medicines and/or MPDs . Notably, acquiring ME and MPDs not included in the pharmacy assortment is not mandatory for conducting post-marketing surveillance. The acquired samples must be submitted to testing laboratories within two business days for laboratory testing to assess compliance with regulatory requirements. Testing laboratories shall conduct tests on samples within five business days. Following the testing, they shall prepare reports that include a statement regarding the conformity or non-conformity of the samples. For pharmaceutical products requiring testing timeframes exceeding five days, including those requiring sterility, testing shall be conducted within a period of fifteen business days. Based on Regulation No. 628, should the findings indicate non-conformance of samples of medicines, MPDs, and ME with regulatory requirements, the Center shall take the following measures within three days: To prevent adverse effects from pharmaceutical products, the Center shall decide to suspend their use in medical practice, withdraw them from circulation, implement destruction procedures, and issue directives to enterprises specifying compliance deadlines, The Center shall require businesses to conduct temporary mandatory certification for the first ten batches of pharmaceutical products manufactured after identifying non-conformance. The Center shall submit a mandatory compliance request to the relevant organizations to conduct an unscheduled inspection on the compliance of entities involved in the circulation of nonconforming medicines with the requirements of Good Practices (GxP) and assess manufacturers of MPDs and ME for compliance with ISO 13485, If post-market surveillance indicates regular (twice or more within one year) nonconformance in one or several products from a single enterprise, the Center shall decide to implement temporary mandatory certifications for all products of that organization for one year, The Center shall take actions to suspend the validity of the registration certificate for medicines, as well as licenses for pharmaceutical activities, and proceed with their annulment per the legislation of the Republic of Uzbekistan, Based on the causes and consequences of recognizing samples as non-conforming, the Center shall send conclusions to the relevant state authorities for legal assessment, The Center shall undertake additional measures as per the legislation of the Republic of Uzbekistan. It is important to note that the Center purchases samples using its extrabudgetary funds to conduct post-marketing surveillance. However, if the samples acquired are found to be non-compliant with regulatory requirements, all expenses, including laboratory research costs, shall be borne by the manufacturing enterprises or organizations engaged in the wholesale trade of pharmaceutical products. The results of post-marketing surveillance will be regularly published on the official website of the Center. Implementation of post-marketing surveillance of pharmaceutical products will begin on January 1, 2025. The Regulation on the reimbursement program for the compensation of medicine expenses in the treatment of diseases in outpatient settings. On October 2, 2024, the Cabinet of Ministers of the Republic of Uzbekistan adopted Resolution No. 619, titled "On the approval of the Regulation on the Reimbursement Program for the Compensation of Expenditures for Pharmaceutical Products in the Treatment of Diseases in Outpatient Conditions" No. 619 ("Regulation No. 619"), which came into effect on October 5, 2024. General information Medications included in the state-guaranteed volume of medical services and medicines are provided to patients free of charge within the reimbursement program, which is predicated on an electronic prescription issued by a physician. Еxpenses incurred by pharmacies for the medications dispensed within the reimbursement program are compensated by the state budget via the State Medical Insurance Fund ("Fund"). А direct contract is concluded between the Fund and the pharmacies, and reimbursements are made by the treasury authorities at least once a month. The Center shall continuously monitor the availability of medicinal products provided within the reimbursement program in the retail sector and must report the monitoring to the Fund by the 5th day of each month. The Ministry of Health of the Republic of Uzbekistan determines the list of diseases included in the reimbursement program and the medicines dispensed for their treatment. The procedure for establishing the maximum reimbursement amount and effectuating payments is approved by the Supervisory Board of the Fund. The maximum reimbursement amount, INN, forms, and dosages of medicines provided within the reimbursement program are determined by a commission established within the Fund. The budget for the reimbursement program is set at up to ten percent of the value of the contract executed between the Fund and the relevant medical facility. Participation of pharmacies in the reimbursement program Pursuant to the Regulation No. 619, medicines dispensed within the reimbursement program shall be provided to a patient free of charge via electronic prescription through the pharmacies that have entered into agreements with the Fund and are connected to the electronic information system. Participating pharmacies are responsible for ensuring the continuous availability of medicines dispensed within this program and maintaining their uninterrupted supply. Pharmacies must notify the Fund within seven days of any disruptions in medicine supply. The Regulation No. 619 establishes the procedure whereby an electronic prescription issued by a physician is forwarded to participating pharmacies, and a patient (or their legal representative or assigned visiting nurse) receives an SMS notification containing the number and date of the electronic prescription. Upon visiting the pharmacy, the patient provides the number of the electronic prescription, and the pharmacy staff dispenses the medicine by requesting a special code sent via SMS. Following the entry of this code into the information system, the patient is supplied with the medicines available at the lowest cost of reimbursement under the program, while the pharmacy staff confirms the dispensing and closes the electronic prescription. If pharmacies charge patients for medicines provided within the reimbursement program or breach the established requirements, the Fund will take the following actions: for the first violation, the pharmacy will receive a warning; for repeated violations, the Fund reserves the right to exclude the pharmacy from the reimbursement program, thereby unilaterally terminating the agreement.