Uzbekistan

On 26 March 2026, the Law of the Republic of Uzbekistan (“Uzbekistan”) “On Amendments and Additions to the Law of Uzbekistan ‘On Personal Data’” No. 1125 (the “Law No. 1125”) was adopted. Below is an overview of the key amendments and additions to the regulation of personal data. The Revised Procedure for Storage of Personal Data of Citizens of Uzbekistan Pursuant to the Law No. 1125, the revised version of the Law “On Personal Data” introduces a substantially new approach to the storage of personal data of citizens of Uzbekistan. Previously, all personal data of citizens of Uzbekistan were subject to mandatory storage within the territory of Uzbekistan. Under the new rules, mandatory localization applies only to the following categories of personal data: biometric data of individuals, genetic data of individuals, data of individuals users of local telecommunications services in Uzbekistan. With respect to other categories of personal data, their storage and processing outside the territory of Uzbekistan is permitted, provided that one of the following conditions is met: the foreign state is recognized as ensuring an adequate level of personal data protection, the operator adopts and complies with standard contractual clauses or binding corporate rules that meet the requirements approved by the authorized state body, the operator complies with international standards in the field of personal data management and storage, as approved by the authorized state body. At the same time, the list of foreign states ensuring an adequate level of personal data protection is determined by the Cabinet of Ministers of Uzbekistan. As of the date of publication of this overview, the list has not yet been approved by the Cabinet of Ministers of Uzbekistan. Rules on the Processing of Personal Data for Personal Purposes Clarified Pursuant to the Law No. 1125, the revised version of the Law “On Personal Data” clarifies that it does not apply to the processing of personal data by an individual for personal and household purposes. At the same time, the provision stating that personal processing should not be related to professional or commercial activities has been removed. Thus, the requirement to separately assess whether that processing is connected to professional or commercial activities has been eliminated, leaving the personal or household nature of the processing as the primary criterion. Scope of Exceptions from the Application of the Law “On Personal Data” Expanded Furthermore, the revised version of the Law “On Personal Data” clarifies that not only the processing of personal data constituting state secrets, but also of the information related to defense and national security is exempt from its scope.   New Initiatives in Regulating the Use of Artificial Intelligence in Uzbekistan On 21 January 2026, the Law of Uzbekistan “On Amendments and Supplements to Certain Laws of Uzbekistan in Connection with Artificial Intelligence Regulation” No. ZRU-1115 (the “Law No. 1115”) was adopted. Below is an overview of the key amendments introduced by the Law No. 1115 concerning the regulation of relations arising from the use of artificial intelligence. Introduction of the Definition of “Artificial Intelligence” Pursuant to the Law No. 1115, amendments and additions were made to a number of regulatory legal acts. In particular, the Law of Uzbekistan “On Informatization” No. ZRU-560-II dated 11 December 2003 (the “Law No. 560-II”) was supplemented with the definition of artificial intelligence (“AI”), which is defined as a set of technological solutions enabling the simulation of human cognitive functions (including self-learning and problem-solving) and producing results in the performance of specific tasks comparable to the results of human intellectual activity. Measures for the Development of AI The Law No. 1115 establishes provisions aimed at further development of AI in Uzbekistan. In particular, amendments to the Law No. 560-II designate the creation of the necessary conditions for the implementation and development of AI as the main area of state policy development, as well as the establishment of the legal, technological, and economic foundations for this development. In addition, the Ministry of Digital Technologies of Uzbekistan, acting as the specially authorized state body, has been vested, inter alia, with the following functions: creating conditions for attracting investment in the AI sector, developing technical infrastructure for data processing of state bodies based on AI technologies, organizing training, retraining, and advanced professional development of specialists in the field of AI. Procedure for the Use of AI in the Creation of Information Resources and Operation of Information Systems In accordance with the Law No. 1115, the Law No. 560-II was supplemented with an additional article regulating the use of AI in the creation of information resources and operation of information systems. Information resources created using AI, as well as information systems operating based on AI technologies, shall not cause harm to individuals, their life, health, freedom, honor, dignity, or violate other inalienable rights. Furthermore, when making legally significant decisions affecting human rights and freedoms, it is prohibited to rely exclusively on conclusions generated by information resources and systems created using AI technologies. Restriction on the Dissemination of Publicly Available Information Using AI Technologies Pursuant to the amendments to the Law No. 560-II, owners of websites and/or website pages, as well as other information resources (the “Information Resources”), including bloggers, are obliged to prevent the use of their Information Resources, on which publicly available information is posted on the global Internet, for the unlawful processing of personal data using AI technologies. A key innovation is the explicit prohibition not only of the unlawful processing, but also of the subsequent dissemination of personal data using AI technologies in mass media, telecommunication networks, or on the Internet. Administrative Liability for Violations of Personal Data Legislation Using AI Technologies In accordance with the Law No. 1115, the Code of Uzbekistan on Administrative Liability was supplemented with provisions establishing administrative liability for the unlawful processing of personal data using AI technologies, as well as their dissemination in mass media, telecommunication networks, or on the Internet. The above violations are punishable by an administrative fine ranging from fifty to one hundred base calculation units (approximately USD 1,690 – 3,380) with confiscation of the instruments of the administrative offense.   Rules on the Use of AI Technologies and Systems Defined in Uzbekistan On 14 March 2026, the Minister of Digital Technologies of Uzbekistan issued Order No. 3787 “On Approval of the Rules of Ethics for the Development, Implementation and Use of Artificial Intelligence-Based Solutions” (the “Order No. 3787”), which will enter into force on 17 June 2026. Below is an overview of the key provisions of the Order No. 3787 governing the development, implementation and use of AI technologies and systems. Ethical Rules Approved and Key AI Concepts Defined Pursuant to the Order No. 3787, the Rules of Ethics for the development, implementation and use of AI-based solutions (the “Ethical Rules”) have been approved. The purpose of the Ethical Rules is to ensure the safe use of AI systems operating based on AI technologies, as well as to protect human rights, freedoms and legitimate interests. The Ethical Rules, inter alia, establish definitions of key terms. In particular, the “Ethical Rules” are defined as a set of fundamental rules and requirements establishing safety and ethical standards for the development, implementation and use of AI-based solutions in relation to AI technologies, AI systems, and AI participants (the “Participants”), referring to natural and legal persons engaged in the development, implementation and use of AI technologies and systems within the territory of Uzbekistan. The Participants are required to strictly comply with the Ethical Rules when using AI technologies and systems. Furthermore, the Participants should not treat decisions made by AI technologies and systems as final decisions. In addition, the Ethical Rules define the concept of “AI systems”. The AI systems are understood as software developed based on AI technologies and capable of performing data search, collection, storage, analysis, processing, evaluation and use, as well as making autonomous decisions based on the data. Key Principles for the Use of AI and Compliance Requirements Established The Ethical Rules establish a number of key principles that are mandatory for compliance by the Participants, including: lawfulness, priority of protecting the interests of the individual, society and the State, as well as the environment, transparency and intelligibility, accountability, responsibility for outcomes, and oversight, fairness and non-discrimination, openness and transparency, information security, reliability and safety. The Ethical Rules also elaborate on the content of these principles. In particular, under the principle of intelligibility, decisions or actions carried out by AI technologies and systems should be understandable to AI participants. This includes ensuring that the logic of operation, key algorithmic criteria, decision-making processes and data sources are transparent and explainable. Users should be informed about the rules governing the use of AI technologies and systems, the purposes for which their use is permitted or prohibited and should also be notified that AI-based decisions or outputs are not always accurate and may be used for advisory or informational purposes. Under the principle of accountability, responsibility for outcomes and oversight, the Participants are responsible for the consequences of the development, implementation and use of AI technologies and systems, within the scope of their actions. All decisions made using AI technologies and systems should remain under human control, be subject to human review, and the final decision should be made by a human. Under the principle of reliability and safety, AI technologies and systems should operate consistently and accurately, with the likelihood of minimizing errors. Secure storage of data input into AI technologies and systems should also be ensured. Particular attention should be paid to the fact that it is not permitted to rely exclusively on the conclusions of information systems and information resources operating on the basis of AI technologies when making legally significant decisions affecting human rights, freedoms and legitimate interests, as well as decisions in the field of healthcare (including disease diagnosis, determination of treatment methods, analysis of medical images, patient data management, etc.). Rights and Obligations of Developers and Implementers of AI Technologies and Systems Established Pursuant to the Ethical Rules, the following rights and obligations of developers and implementers of AI technologies and systems are established: to develop and implement AI technologies and systems in compliance with the Ethical Rules, to protect ownership rights and intellectual property rights in AI technologies and systems, to submit proposals for improving the Ethical Rules, etc. At the same time, developers and implementers of AI technologies and systems are assigned, inter alia, the following obligations: to ensure transparency and intelligibility of AI algorithms, to prevent potential bias in AI technologies and systems, to ensure the protection of personal data and restricted information, to provide clear and accessible information on the capabilities, limitations and potential risks of AI technologies and systems, to inform users about the rules governing the use of AI technologies and systems, the purposes for which their use is permitted or prohibited, and to notify them that AI-based decisions or outputs are not always accurate and may be used for advisory or informational purposes, to ensure human oversight over AI systems, the possibility of human review, and that final decisions are made by a human, not to use AI technologies and systems for purposes contrary to the legislation of Uzbekistan or capable of causing harm to individuals, society, the state, or the environment, to develop and publish user guidelines for the use of AI technologies and systems, etc. Rights and Obligations of Users of AI Technologies and Systems Established Pursuant to the Ethical Rules, users of AI technologies and systems are granted, inter alia, the following rights: to receive information on the rules governing the use of AI technologies and systems, the purposes for which their use is permitted or prohibited, and that AI-based decisions or outputs are not always accurate and may be used for advisory or informational purposes, to use open, transparent and secure AI technologies and systems, to obtain explanations regarding the algorithms of AI systems, to act independently when using AI technologies and systems, to submit proposals to developers and implementers of the AI systems for correction of identified deficiencies, etc. At the same time, users of AI technologies and systems are subject, inter alia, to the following obligations: to comply with the rules and conditions governing the use of AI technologies and systems, to use AI technologies and systems properly, to ensure the protection of personal data and restricted information, not to infringe the copyrights of other users, to comply with the Ethical Rules, not to cause harm to the interests of individuals, society and the State, as well as the environment, etc.       Contacts:     Zafar Vakhidov Partner, Vakhidov & Partners Uzbekistan / Kazakhstan [email protected]         Kamila Sharipova Senior Associate, Vakhidov & Partners Uzbekistan [email protected]         Dilshodbek Egamberdiev Associate, Vakhidov & Partners Uzbekistan [email protected]    

On 5 March 2026, the President of the Republic of Uzbekistan (“Uzbekistan”) signed the Decree «On Additional Measures to Stimulate Production and Improve Research and Development Processes in the Pharmaceutical Industry» No. UP-35 (the “Decree No. 35”), which came into force on 7 March 2026. The key innovations introduced by Decree No.35 include: Establishing target indicators for the development of the pharmaceutical industry in 2026, including increasing production volume to UZS 8.5 trillion and raising exports of goods and services to USD 300 million, Provision of tax incentives to business entities implementing investment projects in the pharmaceutical industry, Introduction of specific regulations governing participation of pharmaceutical enterprises in public procurement, Approval of an action plan aimed at improving production and research processes in the pharmaceutical industry, including the introduction of a “Regulatory Sandbox” regime, Extension of certain customs benefits to enterprises producing dietary supplements (the “DS”) and cosmetic products, Amendments to a number of regulatory legal acts, including those governing state registration of medicines, digital labeling, and financing of investment projects in the pharmaceutical industry. Below is a more detailed overview of the key new developments introduced by Decree No. 35. The following primary development targets for the pharmaceutical industry for 2026 have been established: Increase in pharmaceutical production volume to UZS 8.5 trillion, Formation of prospective investment projects totaling USD 1 billion, Launch of new investment projects totaling USD 800 million, Increase in exports of goods and services to USD 300 million, Development and introduction of 350 new types of products, Expansion of the territory of the innovative scientific and industrial pharmaceutical cluster “Tashkent Pharma Park” with a view to transforming it into a regional research and manufacturing hub in biotechnology and pharmaceuticals – “BioPharma City”. Support Measures have been Established for Pharmaceutical Manufacturers In order to stimulate the production of competitive and high-quality pharmaceutical products, as well as to attract investment into the pharmaceutical industry, Decree No. 35 provides for a number of state support measures. In particular, manufacturers that establish production of original medicines in Uzbekistan within one year after expiration of the patent term for such medicines are eligible for compensation of the following expenses funded by the Pharmaceutical Industry Support and Development Fund: 50% of technology transfer costs, but not exceeding USD 50,000, or 50% of research and development expenses related to the creation of medicines, but not exceeding USD 100,000. Improvement of Regulation of DS and Introduction of Additional Quality and Safety Requirements Pursuant to Decree No. 35, the Ministry of Health is tasked, by the end of May 2026, to develop requirements and procedures for issuing permits for the production of DS at enterprises holding a national GMP certificate. Furthermore, as of 1 January 2027, enterprises holding a national certificate of “Good Manufacturing Practice – GMP” will be allowed to manufacture DS on their production lines for the duration of such certificate. In addition, Decree No. 35 introduces additional requirements aimed at improving the quality and safety of DS. In particular, as of 1 January 2028: The issuance of permits for DS will require the implementation of a Hazard Analysis and Critical Control Points (HACCP) system, DS will be subject to mandatory digital labeling. Tax Incentives for Implementation of Certain Investment Projects in the Pharmaceutical Industry According to Decree No. 35, until 2040, business entities implementing investment projects aimed at the production of pharmaceutical products, cultivation of medicinal plants, and their processing are granted the following tax incentives: exemption from land tax in respect of land plots used for implementation of investment projects for a period of three years from the commencement date of the investment project, exemption from corporate income tax within the framework of the investment project for a period of three years from the date the investment project is put into operation, exemption from property tax in respect of immovable property constructed within the framework of the investment project. These tax incentives apply provided that the share of revenue derived from the sale of manufactured pharmaceutical products, cultivation of medicinal plants, or their processing constitutes at least 60% of the taxpayer’s total revenue. In addition, tax preferences are established for foreign holders of technologies and brands. In particular, for non-residents not operating in Uzbekistan through a permanent establishment, the corporate income tax rate on royalty income derived from technology transfer and brand use applied in the production of medicines and medical devices (“MD”) in Uzbekistan is set at 5% until 1 January 2030, unless otherwise provided by international treaties of Uzbekistan. Compensation Measures for Manufacturers of Medicines and MD Decree No. 35 provides that, as of 1 June 2026, manufacturers of medicines will be reimbursed, at the expense of the Trade Promotion Fund, for 50% of expenses, but not exceeding USD 50,000, related to: engagement of foreign consulting services for the implementation of EU GMP and US FDA GMP standards, obtaining prequalification from the World Health Organization. Additionally, compensation is provided to manufacturers of medicines and MD developed by research institutes and educational institutions and not previously produced in Uzbekistan. Such manufacturers are reimbursed for 80% of expenses related to state registration, clinical trials, and bioequivalence studies, after the commencement of industrial production and commercialization of the respective medicines but not exceeding USD 8,000. Furthermore, business entities that, within three years, commission investment projects for the industrial production of high-tech medicines (as specified in Annex No. 1 to Decree No. 35) are entitled to compensation of interest expenses on loans attracted within such projects, for a period of two years, at the expense of the Pharmaceutical Industry Support and Development Fund. Specific Aspects of Participation in Public Procurement and Distribution of Pharmaceutical Products Decree No. 35 establishes that, as of 1 June 2026, pharmaceutical and other manufacturing enterprises are, by way of exception, permitted to participate in public procurement where: tax and levy arrears do not exceed two times the base calculation amount (approximately USD 68), or such arrears exceed the specified threshold – within 10 days from the date such arrears arise. Admission to participation in public procurement is based on information provided through the information system of the State Tax Committee. In addition, it is established that until 1 September 2026, regardless of the level of localization of production, manufacturing enterprises producing pharmaceutical and other products and holding a certificate of domestic origin are permitted to sell such products through the following mechanisms and electronic platforms: the electronic cooperation portal, the manufacturers’ ecosystem, local auctions, the “national shop”. Approval of an Action Plan for Improving Production and Research Processes in the Pharmaceutical Industry In accordance with Annex No. 3 to Decree No. 35, an action plan aimed at improving production and research processes in the pharmaceutical industry has been approved. Introduction of a Special Legal Regime “Regulatory Sandbox” As part of the measures provided for in the action plan, it is envisaged to submit to the Cabinet of Ministers a proposal on the introduction of a special legal regime “Regulatory Sandbox,” providing for a separate legal framework governing activities related to testing and registration of medicines, MD, new products and services, as well as intellectual property results – by September 2026. The Ministry of Health and the Pharmaceutical Industry Development Agency (the “Agency”) have been designated as the responsible authorities for the implementation of this measure. Inventory of Mandatory Digital Labeling Codes for Medicines A phased inventory of mandatory digital labeling codes for medicines is envisaged within the following timeframes: Stage 1 – manufacturers of medicines – by July 2026, Stage 2 – wholesale distributors of medicines – by September 2026, Stage 3 – pharmacy organizations (retail sale of medicines) – by November 2026. Improvement of Post-Market Surveillance of Pharmaceutical Products Decree No. 35 provides for the improvement of the procedure for post-market surveillance of pharmaceutical products, to be implemented in two stages: Stage 1 – development of a draft regulatory legal act providing for improvements in post-market surveillance procedures – by May 2026, Stage 2 – coordination of the draft regulatory legal act with relevant ministries and authorities and submission thereof to the Cabinet of Ministers – by August 2026. Improvement of the Procedure for Distribution and Circulation of Medicines and MD In addition, by June 2026, it is envisaged to develop a draft regulatory legal act aimed at improving the procedures for wholesale and retail distribution of medicines and MD, as well as their write-off and destruction. Coordination of this draft regulatory legal act with relevant ministries and authorities and its submission to the Cabinet of Ministers in accordance with the established procedure is scheduled for completion by September 2026. Extension of Certain Customs Benefits to DS and Cosmetic Products In accordance with Decree No. 35, as of 1 April 2026, customs benefits provided under the Presidential Decree No. UP-55 dated 21 January 2022 “On Additional Measures for Accelerated Development of the Pharmaceutical Industry of the Republic in 2022–2026” are extended to enterprises producing DS and cosmetic products, in respect of the following equipment and goods: technological and laboratory equipment not produced in Uzbekistan, as well as components and spare parts thereto, “clean rooms,” sandwich panels, and ventilation systems for pharmaceutical production facilities, as well as raw materials and supplies, MD, and packaging materials used for maintaining laboratory animals, conducting preclinical studies, and manufacturing medicines (including extemporaneous compounding), imported by: manufacturers of pharmaceutical products, wholesale distributors of pharmaceutical products, specialized research institutes and higher educational institutions for their own needs, enterprises engaged in wholesale distribution of pharmaceutical products for the needs of pharmaceutical manufacturers, enterprises engaged in wholesale and retail distribution of pharmaceutical products – for extemporaneous compounding of medicines. Tax Treatment of Transfers of Medicines and MD as Humanitarian Aid In accordance with Decree No. 35, specific tax rules have been established for accounting of medicines and MD transferred as humanitarian aid. Such transfers, subject to compliance with the established requirements, are recognized as economically justified expenses of pharmaceutical organizations for tax purposes. Decree No. 35 also provides for rules on valuation of transferred products and establishes liability measures in cases of overstatement of value, fictitious transfers, re-circulation of transferred property, or non-compliance with the established transfer procedure. Establishment of the National Research Institute of Biopharmaceuticals Pursuant to Decree No. 35, the National Research Institute of Biopharmaceuticals (the “Institute”) is to be established based on the following research organizations: the Uzbek Chemical and Pharmaceutical Research Institute, the Tashkent Research Institute of Vaccines and Serums, the “Sharq tabobati” Research Institute. Amendments to Regulatory Legal Acts Expansion of Grounds for Regulatory Control in the Pharmaceutical Industry In accordance with Decree No. 35, amendments have been introduced to the Presidential Decree No. UP-184 dated 14 November 2024 “On Measures to Ensure Reliable Protection of the Rights and Legitimate Interests of Entrepreneurs,” expanding the grounds for exercising control over the production, manufacturing, wholesale, and retail distribution of medicines and MD. Previously, such control could be conducted only upon availability of reliable information regarding the production, manufacturing, or sale of falsified or substandard products, as well as reliable information on retail sales of prescription medicines without a prescription. Under Decree No. 35, an additional ground for conducting control has been introduced, namely, a negative conclusion based on the results of post-market surveillance of pharmaceutical products. Accordingly, post-market surveillance of pharmaceutical products has been included among the grounds for conducting control measures by the Safety Center. Expansion of the Scope of Participants in the Digital Labeling System for Medicines and MD Furthermore, amendments have been introduced to the Resolution of the Cabinet of Ministers No. 149 dated 2 April 2022 “On the Introduction of a Mandatory Digital Labeling System for Medicines and Medical Devices” (the “Resolution No. 149”), expanding the list of entities entitled to receive digital labeling codes for medicines and MD. Under the revised version of the Resolution No. 149, importers have been additionally included among the entities entitled to receive such digital labeling codes. In addition, Resolution No. 149 has been supplemented with a new provision requiring that, upon obtaining digital labeling codes for medicines and MD, importers must provide power of attorney from the foreign manufacturer, duly confirmed by the competent authorities of the foreign state, authorizing them to obtain such codes. Moreover, while previously the labeling of medicines and MD – including ordering and obtaining labeling codes from the Operator, converting such codes into digital identification means, and applying them to consumer packaging – was ensured solely by manufacturers, it is now also ensured by importers. Simplification of Registration of Certain Medicines Decree No. 35 also introduces amendments to the Resolution of the Cabinet of Ministers No. 738 dated 24 November 2025 “On Approval of Regulations on the Procedure for State Registration of Medicines and the Procedure for State Registration of Medical Devices” (the “Resolution No. 738”). According to the amendments, medicines containing identical active substances and produced by domestic manufacturers on a contractual basis under different trade names may be registered through recognition without conducting laboratory testing. At the same time, it is established that such medicines must fully correspond to the reference medicine in terms of the manufacturer of the active pharmaceutical ingredient, composition of excipients, primary packaging materials, container-closure system, quality control methods and specifications, and manufacturing technology. Changes are permitted only in the trade name, secondary packaging design, and instructions for use. Simultaneously, it is provided that the first industrial batch of medicine registered under this procedure is subject to mandatory post-market surveillance. Specific Aspects of Conducting Clinical Trials for Registration of Original Medicines In addition, Resolution No. 738 has been supplemented with a new provision under which, upon state registration of original medicines, clinical trials may not be required if such medicines are supported by positive results of international multicenter clinical trials. Contacts:     Zafar Vakhidov Partner, Vakhidov & Partners Uzbekistan / Kazakhstan [email protected]         Kamila Sharipova Senior Associate, Vakhidov & Partners Uzbekistan [email protected]           Dilshodbek Egamberdiev Associate, Vakhidov & Partners Uzbekistan [email protected]      

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.