Uzbekistan

What is a clinical trial? A clinical trial (“CT”) is a study involving human subjects, conducted to identify or confirm the safety and effectiveness of means, methods, and technologies for the prevention, diagnosis, and treatment of diseases. What types of CTs are there? A non-interventional CT is a study which is conducted after the state registration of a medicine or medical device (“MD”) and is prescribed as part of medical practice. An interventional trial is a study involving a human subject in which a researcher-physician assigns a specific intervention to the subjects based on an interventional CT protocol which complies with the CT procedure. Is a notification/permission required to conduct clinical trials? To conduct an interventional CT of a medicine, it is necessary to obtain a permission from the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the Republic of Kazakhstan. Before obtaining the permission, it is necessary to obtain a conclusion on the results of the examination of the CT materials from the National Center for Expertise of Medicines and MDs, as well as a conclusion on the results of the bioethical examination of the CT materials from the Central or Local Bioethics Commission. For non-interventional CT notification is required. For non-interventional CT, it is necessary to obtain a conclusion based on the results of a bioethical examination of the CT materials from the Central or Local Bioethics Commission. In the Republic of Kazakhstan (“RK”), the main legal acts regulating CT are: The Code of the RK dated July 7, 2020 No. 360-VI "On Public Health and the Healthcare System" Defines the legal bases for regulating and conducting CT of Medicines, MDs, and clinical laboratory tests of MDs for diagnostics outside a living organism (in vitro). Rules of Good Clinical Practice of the Eurasian Economic Union, approved by the Decision of the Council of the Eurasian Economic Commission of November 3, 2016 No. 79 Establish international ethical and scientific standards for planning and conducting studies involving human subjects, as well as for the documentation and presentation of the results of these studies. The Standard of Good Clinical Practice (GCP), approved by the Order of the acting Minister of Healthcare of the RK dated February 4, 2021, No. ҚР ДСМ-15) Establishes rules for conducting studies involving human subjects, as well as for the documentation and presentation of the results of these studies. ISO 14155:2014, Recommendation of the Board of the Eurasian Economic Commission of September 4, 2017, No. 17: CT of MDs involving human subjects. Good clinical practice. Establishes provisions for good clinical practice for the planning, conduct, documentation, and reporting of results of CT involving human subjects to evaluate the safety or performance of MDs. Rules for Сonducting СT of Medicines and MDs for In Vitro Diagnostics and Requirements for Clinical Sites and for the Provision of the Public Service "Issuance of Permission to Conduct CT and/or Testing of Pharmacological and Medicinal Products, MDs, approved by order of the Minister of Healthcare of the RK dated December 11, 2020 No. ҚР ДСМ-248/2020 Establish the procedure for conducting CTs of Medicines and MDs, clinical laboratory tests of MDs for diagnostics outside a living organism (in vitro) and requirements for clinical bases. Key regulatory bodies Ministry of Healthcare of the RK The Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the RK Issues permission to conduct CT and/or testing of pharmacological and medicinal products, MDs; Conducts CT inspections. National Center for Expertise of Medicines and MDs Conducts an examination of CT materials and issues a conclusion on the conduct of CT. Central Commission on Bioethics Conducts a bioethical examination of CT materials and issues opinions on the conduct of interventional CT of foreign-produced medicines and MDs, as well as interventional and non-interventional CTs of Medicines and MDs conducted in two or more research centers located in the territory of the RK. Local Bioethics Commission Conducts a bioethical examination of materials of single-center interventional and non-interventional CTs, with the exception of cases of interventional CTs of Medicines and MDs produced outside the RK. What are the requirements for clinical sites? The requirements for clinical sites: availability of a license to carry out medical activities; availability of standard operating procedures for conducting CTs; availability of clinical, instrumental and laboratory equipment for conducting CTs or availability of contracts with contractors for the provision of specialized clinical, instrumental, laboratory and auxiliary services for conducting CTs (in the absence of the necessary equipment); availability of personnel with medical education and a GCP training document; availability of conditions for intensive care and resuscitation (if required by protocol); availability of a document establishing the procedure for working with confidential information. GCP and ISO14155:2014 standards set more detailed requirements for clinical sites. Are there any CT inspections in the RK? Inspections are carried out by the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the RK in accordance with the Rules for Conducting Pharmaceutical Inspections on Good Pharmaceutical Practices, approved by Order No. ҚР ДСМ-9 of the Minister of Healthcare of the RK dated January 27, 2021. The objectives of the inspection are the following: assessment of compliance with GCP and ISO 14155:2014 standards; confirmation of compliance of the CT with the approved CT protocol; confirmation of the reliability of the data obtained as a result of CTs; investigation of complaints (signals) received with regard to the CT, as well as upon receipt of additional information about the risk associated with conducting the CT; protection of the rights, health and well-being of the subjects of CTs. Inspection is carried out at any stage of the CT in a planned (primary) or unscheduled manner (including in connection with a threat or harm to the life or health of trial subjects). The Ministry of Healthcare of the RK, based on the inspection data, makes a decision on: termination of CT; recognize the results of the CT. What are the requirements for participation in the CT? The need to obtain informed consent:. Before inclusion in the CT, the trial subject or their legal representative shall receive the information about the planned CT, on the basis of which the trial subject or their legal representative signs the informed consent for voluntary participation in the trial. Restrictions on participation in CTs for certain categories of persons: CTs of medicines and MDs on minors, pregnant women, incapacitated individuals, students, pensioners, and those requiring assistance are conducted only to study the therapeutic effect and with the consent of a relative, guardian, or parent. Prohibition of participation in CTs for certain categories of persons: interventional CTs on military, law enforcement and special government agencies’ personnel, employees of medical organizations where biomedical research is conducted, and persons held in penal institutions are prohibited. What constitutes the result of the CT? The result of the CT is the final report on the conducted CT of medicines and MDs, regardless of whether the trial was completed or terminated early. No later than 1 year after the full completion of the CT (in case of international CTs, after the completion of the CTs in all countries), the sponsor provides brief information about the CT to the Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the RK and the Central Bioethics Commission which issued the permission to conduct the CT. The sponsor and the investigator archive the materials (documents) of the CTs and ensure their safety for 25 years from the date of completion of the CT. As of the publication date of this alert, the draft regulations on CT are under public discussion; therefore, further amendments may be introduced.  

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.

Advertising in Uzbekistan is under increasingly close regulatory oversight, marking a new stage in the development of the country’s media and marketing landscape. This evolution is driven by two converging factors: the rapid growth of consumer activity in digital spaces and the state’s expanding focus on compliance and transparency across both traditional and online forms of advertising. At the forefront of this regulatory process stands the Anti-Monopoly Committee of the Republic of Uzbekistan, which conducts regular monitoring exercises to identify and address breaches of the Law “On Advertising”. While its oversight historically concentrated on outdoor advertisements – billboards, banners, and other public displays, the Committee has increasingly turned its attention to the digital environment, where violations can spread more quickly and reach a broader audience. In today’s Uzbekistan, social media platforms such as Telegram, Facebook, Instagram, and LinkedIn have become the dominant channels for marketing and brand communication. This transition from physical to digital advertising has prompted broader discussions on consumer protection, emphasizing the importance of truthful, transparent, and ethical promotion in the online sphere. It has also exposed gaps in the existing legal framework, reinforcing the government’s efforts to modernize the country’s advertising laws in line with the realities of an increasingly digital economy. Legal Framework The primary piece of legislation governing advertising in Uzbekistan is the Law of the Republic of Uzbekistan “On Advertising”. The law establishes general requirements for advertising content, including truthfulness, fairness, and the protection of minors and consumers from misleading or unethical marketing. The advertising framework in Uzbekistan is further supported by several complementary legal and administrative instruments. The Law “On Protection of Consumer Rights” establishes safeguards against misleading or unfair advertising and provides mechanisms for consumer compensation, while the Law “On Trademarks, Service Marks and Appellations of Origin of Goods” clarifies the lawful use of trademarks in promotional materials and protects rights holders against unauthorized or deceptive references. The regulation of outdoor advertising is additionally supported by a series of Cabinet of Ministers resolutions, notably Resolution No. 104 of 20 February 2020 “On Regulation of the Outdoor Advertising Market”, together with Resolutions No. 702 of 30 August 2018 and No. 428 of 31 August 2023, which further elaborate on coordination procedures, technical and safety standards, and municipal approval processes. Language requirements Uzbek law requires that all advertising distributed within the country be presented in the state language (Uzbek).[1] However, the use of foreign languages is permitted, provided that the Uzbek version is also available and that the foreign-language text does not distort or misrepresent the meaning of the original message. For outdoor advertising, the translated text must be placed horizontally at the bottom of the Uzbek-language text and may not exceed 40% of the total advertising area. For television, radio and print media, translated advertising in other languages must not exceed 20% of the total daily volume of advertising. The font of any translated text must be smaller than the font of the Uzbek-language text.[2] Exceptions to these limits apply where media are produced exclusively in a foreign language (for example, print editions or broadcasts in a foreign language and websites that publish only in foreign languages).[3] One of the practical advantages of having a registered trademark in Uzbekistan is that it allows the brand owner to use the mark in its original linguistic and graphic form, regardless of whether it is in Uzbek or a foreign language.[4] A registered trademark enjoys legal protection in the exact form in which it is registered, be it Latin, Cyrillic, or any other script, and may therefore appear in advertisements without translation. By contrast, if a foreign-language brand or logo has not been registered as a trademark in Uzbekistan, advertisers are generally expected to provide a translation or transliteration into Uzbek to avoid claims of misleading consumers or violating language-use requirements. This framework reflects a balanced approach, it safeguards the linguistic rights of consumers while giving brand owners a clear incentive to secure trademark protection locally, ensuring full freedom to use their brand identity across all media channels. Sector-Specific Restrictions Alongside the general language requirements, Uzbek advertising law also imposes standard sector-specific restrictions that apply to certain sensitive industries. Stricter rules govern the promotion of pharmaceuticals, supplements, energy drinks, alcohol, financial and insurance services, and products intended for minors.[5] The law expressly prohibits advertising of certain goods, including tobacco products, gambling and breast milk substitutes.[6] A limited exception applies to alcoholic beverages such as beer, natural and sparkling wines, which may be advertised only under specific conditions, for example, in venues where tasting, demonstrations, or brand events are held, and in compliance with strict content and restrictions established by law.[7] IP Issues in Advertising Advertising activities are closely linked with intellectual property rights, particularly trademark and copyright law. Under the Law “On Trademarks, Service Marks, and Appellations of Origin of Goods”, the use of a trademark in advertising is recognized as one of the forms of trademark use.[8] This means that if a company uses another party’s trademark in its advertisement without consent, such use may constitute trademark infringement, even if the advertisement itself appears lawful under advertising law. Uzbek legislation permits comparative advertising, for example, where a product’s features are contrasted with that of competitors. However, such comparisons must be factually substantiated and not defamatory.[9] Comparative advertising that discredits a competitor’s business reputation, goods, or trademarks may be deemed unlawful.[10] In other words, comparative advertising is allowed only when it remains truthful, objective, and non-misleading. Advertisers must also respect copyright protections. Copying, reproducing, or imitating another party’s artistic works, text, design elements, or music without permission is prohibited and may give rise to liability.[11] In practice, these overlapping regimes mean that advertising in Uzbekistan must be both creatively persuasive and legally cautious. Marketing campaigns that reference competitors or borrow artistic elements should undergo prior legal review to ensure compliance with IP and advertising legislation alike. Outdoor Advertising Outdoor advertising in Uzbekistan is subject to specific regulatory requirements, reflecting its impact on urban design and public safety. The installation of billboards, pylons, signs, and other outdoor advertising structures requires obtaining an official “advertising place passport”— a document granting the right to place the construction at a particular site or building.[12] The placement schemes for such advertising structures are approved by local authorities and must comply with urban planning and architectural regulations.[13] All structures must also meet technical safety standards, including requirements for structural strength, secure installation, and minimum distance from roads and pedestrian areas.[14] Advertising objects erected without a valid passport are considered unauthorized and may be dismantled by competent authorities.[15] Holders of advertising places are required to pay prescribed fees in a timely manner, failure to do so can result in revocation of the passport and re-auctioning of the advertising site through an electronic bidding platform.[16] Furthermore, the law prohibits outdoor advertising on cultural heritage sites, road signs, traffic lights, and other urban infrastructure elements, underscoring the balance between commercial expression and public interest.[17] Liability for infringement Liability for breaches of advertising rules under Uzbek law encompasses both administrative and civil measures. Under the Code of the Republic of Uzbekistan on Administrative Liability, fines are imposed on advertisers, producers, and distributors depending on their role in the dissemination of unlawful advertising. Advertisers bear responsibility for the content and accuracy of the information; producers are liable for the preparation of the advertising material; and distributors, including television channels, online platforms, and outdoor operators, are accountable for compliance with placement, timing, and form requirements.[18] Administrative penalties apply for misleading or prohibited advertising, failure to carry out “counter-advertising” when ordered by the regulator, or breaches of disclosure obligations.[19] The amount of fines varies depending on the severity of the violation, ranging from thirty to one hundred basic calculation units (BCUs). As of today, one BCU equals UZS 412,000 (approximately USD 35). Accordingly, fines may range from about USD 1,050 to USD 3,500. In particular, unlawful advertising of prohibited or restricted products is punishable by a fine of up to 100 BCUs (≈ USD 3,500); misleading advertising or failure to publish counter-advertising — up to 70 BCUs (≈ USD 2,450); breaches related to alcohol, tobacco, energy drinks, weapons, or outdoor advertising — up to 50 BCUs (≈ USD 1,750); and violations concerning advertising aimed at minors or involving pharmaceuticals, biologically active additives, or child nutrition — up to 30 BCUs (≈ USD 1,050). [20] From a civil perspective, consumers misled by false or deceptive advertising may seek compensation for damage caused by reliance on such information.[21] Additional sanctions may include suspension of advertising activities or revocation of permits for outdoor advertising. The Anti-Monopoly Committee of Uzbekistan serves as the primary enforcement body overseeing compliance with advertising law. It has the authority to investigate breaches, issue binding orders to cease unlawful advertising, and require the publication of corrective materials even prior to judicial proceedings.[22] Expected Amendments Uzbekistan’s advertising and media landscape is rapidly evolving alongside the country’s broader digital transformation. While the current legal framework provides a solid basis for regulating traditional forms of advertising, online and digital platforms remain relatively underregulated. This gap has become increasingly evident with the growth of social media marketing, influencer collaborations, and online marketplaces, which now dominate much of the country’s promotional activity. Recognizing this challenge, the government has initiated a series of legislative reforms aimed at strengthening consumer protection in the digital sphere. In March 2025, a draft Law “On the Protection of Rights of Users of Online Platforms and Websites” was introduced for public discussion. The proposed law introduces a comprehensive framework to regulate online content, advertising practices, and the responsibilities of digital actors including bloggers, influencers, and platform operators thereby addressing long-standing gaps in the regulation of digital media and online advertising. If enacted, this law would mark a major step in aligning Uzbekistan’s digital ecosystem with international trends, bridging the gap between the Law “On Advertising”, Law “On Informatization”, and consumer protection legislation. It would also formally extend the state’s oversight over online advertising content, particularly influencer marketing, a domain that has so far remained largely outside the scope of existing regulation. Conclusion Uzbekistan’s advertising regulation is undergoing a period of modernization marked by enhanced transparency mechanisms, digital monitoring tools, and an expanded scope of liability. While the Law “On Advertising” remains the central legal instrument, accompanying sectoral and administrative acts reflect the government’s commitment to building a more accountable and competitive advertising environment. For international businesses, these developments introduce both opportunities and compliance challenges, as stricter content standards, electronic monitoring systems, and forthcoming rules for influencers and online platforms will require careful adaptation to the evolving framework. Companies that proactively align their advertising strategies and contractual arrangements with these emerging regulatory requirements will be best positioned to operate transparently, protect their brand reputation, and maintain consumer trust in Uzbekistan’s market. Authors: - Jamshid Agzamkhadjaev (Managing Partner, Settle Law Firm) - Saida Djunaydullaeva (Paralegal, Settle Law Firm) References [1] Law of the Republic of Uzbekistan “On Advertising” No. ZRU-776 of 7 June 2022, Art. 6 (1). [2] Ibid, Art. 6 (2). [3] Ibid, Art. 6 (3). [4] Ibid, Art. 6 (4). [5] Ibid, Art. 34, 35, 37, 38, 42-45. [6] Ibid, Art. 36, 40, 41, 46. [7] Ibid, Art. 39. [8] Law of the Republic of Uzbekistan “On Trademarks, Service Marks and Appellations of Origin of Goods” No. 267-II of 30 August 2001, Art. 27 (2). [9] Law of the Republic of Uzbekistan “On Advertising” No. ZRU-776 of 7 June 2022, Art. 16 (2). [10] Ibid, Art. 16 (2). [11] Ibid, Art. 4. [12] Ibid, Art. 25. [13] Ibid, Art. 23 (7). [14] Resolution of the Cabinet of Ministers of the Republic of Uzbekistan No. 104 of 20 February 2020 “On Regulation of the Outdoor Advertising Market”. [15] Law of the Republic of Uzbekistan “On Advertising” No. ZRU-776 of 7 June 2022, Art. 25 (6). [16] Ibid, Art. 24 (3). Resolution of the Cabinet of Ministers of the Republic of Uzbekistan No. 104 of 20 February 2020 “On Regulation of the Outdoor Advertising Market”, para. 96 (e). [17] Law of the Republic of Uzbekistan “On Advertising” No. ZRU-776 of 7 June 2022, Art. 26 (3). [18] Ibid, Art. 49. [19] Ibid, Art. 47. [20] Resolution of the Cabinet of Ministers of the Republic of Uzbekistan No. 104 of 20 February 2020 “On Regulation of the Outdoor Advertising Market”, para. 96 (e). [21] Law of the Republic of Uzbekistan No. 221-I of 26 April 1996 “On Protection of Consumer Rights”, Art. 7 (3). [22] Law of the Republic of Uzbekistan “On Advertising” No. ZRU-776 of 7 June 2022, Art. 8.

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]