Vakhidov & Partners

The Law of the Republic of Kazakhstan dated November 17, 2025, No. 230-VIII "On Artificial Intelligence" (the "Law") establishes the legal framework for regulating artificial intelligence ("AI") in the Republic of Kazakhstan ("Kazakhstan"), based on the principles of legality, fairness, transparency, accountability, data protection, and the priority of human well-being. The Law defines the following: Terms in the field of AI The Law defines the terms “AI”, “AI System”, “AI Model”, “Data Library”, “Synthetic Outputs of AI Systems”, “Output of AI System”, “National AI Platform”, “Machine-Readable Form”, etc. According to the Law: AI is the functional ability to imitate cognitive functions which are characteristic of humans, providing results comparable to or superior to the results of human intellectual activity; AI System is an information technology object which functions on the basis of one or several AI models; AI Model is a software product developed to perform specialized tasks and capable of adapting to changing conditions, learning from accumulated experience, and optimizing the processes and results of its activities; Output of AI System is information or a decision, regardless of the form in which they are provided, or actions, including work and/or services, produced and/or provided by the AI ​​System. Powers of government agencies in the field of AI The Government of Kazakhstan, the authorized body in the field of AI (the Ministry of AI and Digital Development of Kazakhstan), and industry-specific government agencies are vested with powers in the field of AI. In particular, the Government of Kazakhstan approves a list of priority economic sectors for AI implementation. The Ministry of AI and Digital Development of Kazakhstan exercises oversight and regulatory functions in the field of AI. Industry-specific government agencies create industry Data Libraries in accordance with data management requirements. The Operator of the National AI Platform, National Information Technologies JSC, is designated as responsible for the creation, development, and operation of the National AI platform, as well as for the performance of other functions in the field of AI. Copyright Works created using AI are protected only if they contain a human creative contribution. Using works to train AI models is not automatically considered free use; the absence of a prohibition from the author, expressed in machine-readable form, is required. According to the Law of Kazakhstan dated June 10, 1996, No. 6-I "On Copyright and Related Rights," copyright is the personal non-property and property rights of the author, and the author is an individual whose creative work creates a work of science, literature, or art. Accordingly, copyright is vested in the individual. Rights and responsibilities of AI System owners/holders and users The Law defines the rights and obligations of owners/holders of AI Systems and users. Thus, owners/holders of AI Systems, among other things, have the right to determine the terms of use of AI Systems and protect their rights to AI Systems and are obliged to manage risks, ensure the security and reliability of AI Systems, maintain documentation, support users, and provide terms of use in advance. Users have the right, among other things, to review the terms of use, protect their personal data and intellectual property rights, receive explanations regarding the Outputs of AI System, which affects their rights, freedoms, and legitimate interests, request information about the data on which the AI ​​System based its decisions, and refuse the use of AI (unless required by law). Users are also obligated to use AI within the limits of their granted access rights and comply with security measures and rules. Transparency in the use of AI Systems, including labeling Any distributed synthetic images/text/videos and other Synthetic Outputs of AI Systems must be machine-readable and marked with a visual or other warning. Users must be notified about the use of AI Systems in the production of goods, performance of work, and provision of services. The responsibility for informing users about the Synthetic Outputs of AI Systems rests with the owners or holders of these systems. According to the Law, Synthetic Output of AI System is an image, video, audio, text, or combination thereof, created or modified by an AI System, simulating the appearance, voice, behavior of an individual, or events which have not actually occurred. Classification and risk assessment AI Systems are classified by risk, autonomy, and mode of use, and are subject to appropriate risk management measures, documentation, and controls. Mandatory documentation and audit Owners and holders of AI Systems are required to manage the risks of AI Systems and maintain documentation for the AI ​​System, depending on the degree of its impact on the security, rights, freedoms, and legitimate interests of individuals and public order in accordance with the list of documentation for AI Systems, which is approved by the authorized body in the field of AI (the Ministry of AI and Digital Development of Kazakhstan). Lists of trusted high-risk AI Systems are compiled by industry-specific government agencies to ensure trust and promote best practices for the use of AI Systems in the relevant industry. These lists are regularly published on government agency websites in the manner determined by the authorized body (the Ministry of AI and Digital Development of Kazakhstan). Owners and/or holders of AI Systems applying for inclusion on the trusted list must conduct an audit of their AI Systems. AI System audits are conducted by qualified persons/entities in accordance with the Rules for Conducting Information System Audits and the agreement between the client and the auditor. Rules for work with Data Libraries The Law establishes requirements for the quality and transparency of the origin of Data Libraries. Data Library is a collection of structured and/or grouped data suitable for training AI Models. Information about the creator of the Data Library must be provided in machine-readable form when creating the Data Library and when sharing it, regardless of any subsequent transfer of ownership or possession. AI Models are trained using Data Libraries provided by data owners or holders for pre-defined and legitimate purposes. Functional limitations (prohibitions) The Law prohibits the implementation of functions which use subconscious, manipulative, or other methods to distort an individual's behavior and limit their ability to make informed decisions or force them to make decisions which could cause harm or create a threat of harm, classify people based on sensitive characteristics for the purpose of discrimination, determine emotions without consent, etc. Automated processing Users in relation to whom decisions are made using AI Systems have the right to be informed about the automated processing procedure and its consequences, the possibility of objecting to automated processing, as well as the procedure for protecting their rights, freedoms, and legitimate interests. National Platform Provisions have been introduced according to which the National AI Platform provides a controlled environment for the development, training, and trial operation of platform-based software products and AI Models for a limited period of time. Access to computing resources is provided by the Operator of the National AI Platform (National Information Technologies JSC) in accordance with the rules approved by the authorized body (the Ministry of AI and Digital Development of Kazakhstan). Insurance and legal liability Compensation for damage caused by AI Systems is provided in accordance with the procedure established by the Civil Code of Kazakhstan. Liability insurance for damage caused by AI Systems and risks associated with the use of AI Systems is provided in accordance with the laws of Kazakhstan. The Law enters into force 60 calendar days after its first official publication, which took place on November 18, 2025, i.e., on January 18, 2026. The Law of Kazakhstan No. 231-VIII of November 17, 2025, “On Amendments and Supplements to Certain Legislative Acts of the Republic of Kazakhstan on Artificial Intelligence and Digitalization” was adopted The Law of Kazakhstan dated November 17, 2025 No. 231-VIII "On Amendments and Additions to Certain Legislative Acts of the Republic of Kazakhstan on Artificial Intelligence and Digitalization" (the "Law No. 231-VIII") amends the following legislative acts: Law of Kazakhstan dated September 15, 1994 "On Operational-Investigative Activities"; Law of Kazakhstan dated December 21, 1995 "On the National Security Agencies of the Republic of Kazakhstan"; Law of Kazakhstan dated April 12, 2004 "On Regulation of Trade Activities"; Law of Kazakhstan dated July 5, 2004 "On Communications"; Law of Kazakhstan dated May 4, 2010 "On Protection of Consumer Rights"; Law of Kazakhstan dated May 21, 2013 "On Personal Data and Their Protection"; Law of Kazakhstan dated May 16, 2014 "On Permits and Notifications"; Law of Kazakhstan dated November 24, 2015 "On Informatization"; Law of Kazakhstan dated April 9, 2016 "On Post"; Law of Kazakhstan dated February 6, 2023 "On Digital Assets in the Republic of Kazakhstan"; Law of Kazakhstan dated June 19, 2024 "On Mass Media". Key changes include the following: Law of Kazakhstan dated April 12, 2004 "On Regulation of Trade Activities" Introduction of a provision that domestic trade entities when retailing goods marked with identification means in the manner established by the legislation of Kazakhstan on the regulation of trade activities are obliged to record transactions through cash register machines with the function of recording and/or transmitting data by reading identification means. Law of Kazakhstan of May 4, 2010 "On Protection of Consumer Rights" Introduction of a requirement that the seller (manufacturer, contractor) is obliged to inform the consumer about the possible risks and conditions for the safe use of goods (work, service) containing AI components (produced, performed and/or provided by AI System), by indicating the necessary information in the documentation attached to the goods (work, service), on consumer packaging, labels or in another manner approved for certain types of goods (works, services). Law of Kazakhstan dated May 21, 2013 "On Personal Data and Their Protection" The term "personal data" has been amended. In the new version, personal data ("PD") are data, including biometric data (previously - information), related to a specific or determinable subject of PD, recorded on electronic, paper and/or other tangible media; The term “Automated Processing of PD” has been introduced; Introduction of a rule that the collection and processing of PD for the purpose of causing property damage and/or moral harm, restricting the exercise of rights, freedoms and legitimate interests of the subject is not permitted; Introduction of a rule prohibiting the collection and processing of PD for the purpose of creation or expansion of databases through inappropriate extraction of PD from publicly available sources; Introduction of a rule that the use of technological means for collecting biometric data and identifying a subject in public places, as well as the use of collected biometric data and identification information may be carried out solely for the purpose of protecting the constitutional order, protecting public order, human rights and freedoms, and the health and morals of the population, except in cases where the consent of the subject has been obtained; Introduction of a provision stating that the validity period of consent to PD processing cannot exceed the period necessary to achieve the purposes of collecting and processing PD, unless otherwise provided by the laws of Kazakhstan or an agreement. If the validity period of consent to collect and process PD is not specified, it is considered valid until the processing purposes specified at the time of its provision have been achieved. Introduction of a rule that if a subject revokes consent to the collection and processing of PD, the owner and/or operator, as well as a third party are required to stop processing PD within 15 business days unless their storage or processing is required in accordance with the legislation of Kazakhstan or provide a reasoned refusal; Requirements for automated processing of PD have been transferred and adapted from the Law of Kazakhstan dated November 24, 2015, No. 418-V "On Informatization". A requirement has been introduced that the owner and/or operator, as well as a third party are obligated to consider an objection to the automated processing of PD within 3 business days of its receipt and notify the subject of the results of the objection. Law of Kazakhstan dated February 6, 2023 "On Digital Assets in the Republic of Kazakhstan" Introduction of the terms "Digital Asset Turnover" and "Digital Asset Issue." Digital Asset Turnover means the execution of civil law transactions involving a digital asset; Digital Asset Issue means an action aimed at creating a digital asset as an object of civil rights; Amendments in the "Digital Mining Data Processing Center" term. Digital Mining Data Processing Center is an information and communications infrastructure facility consisting of a hardware and software complex for digital mining, ensuring the operation of computing power, located (previously - and an industrial building located) outside the territory of a residential area, using electrical energy in accordance with the Law of Kazakhstan "On Electric Power Industry"; Amendments in the "Digital Mining Pool" term. Digital Mining Pool is a legal entity accredited in accordance with the legislation of Kazakhstan on digital assets, providing a service constituting combination of the capacities of a hardware and software complex for digital mining of digital miners, distributing digital assets among digital miners which arose (or were created) (previously - were received) as a result of their joint activities; Exclusion of the rule that in the event of the sale of digital assets obtained as a result of digital mining on the territory of Kazakhstan, these digital assets are subject to mandatory sale through digital asset exchanges licensed by the Astana International Financial Center, in an amount of at least 75 percent in accordance with the rules for submitting information on the income of digital miners and digital mining pools for tax purposes; Exclusion of the rule that prohibits digital miners from engaging in other activities not related to digital mining, as well as the acquisition of shares in the authorized capital or stocks of legal entities, the creation and participation in the activities of non-profit organizations, with the exception of membership in a self-regulatory organization and the National Chamber of Entrepreneurs of Kazakhstan; Introduction of a rule that organizing of digital assets circulation shall be carried out by digital asset exchanges; Introduction of a rule that the National Postal Operator of Kazakhstan has a right to open bank accounts in accordance with the legislation of Kazakhstan for the digital asset exchange as well as for a participant in the Astana International Financial Center which has the appropriate license to carry out activities related to digital assets; The provision that the issue and circulation of unsecured digital assets as well as the activities of digital asset exchanges related to unsecured digital assets shall be prohibited on the territory of Kazakhstan, with the exception of the territory of the Astana International Financial Center and the special regulatory regime of the National Bank of Kazakhstan, has been replaced by a provision that the organization of the circulation of digital assets without an appropriate license or permit to carry out activities related to digital assets, issued in accordance with the current law of the Astana International Financial Center or the laws of Kazakhstan shall be prohibited. Law of Kazakhstan dated June 19, 2024 "On Mass Media" Introduction of a rule stating that the distribution of mass media products created using an AI system shall be permitted only if information about these products is provided in accordance with the Law of Kazakhstan "On Artificial Intelligence." The Law No. 231-VIII shall enter into force 60 calendar days after the date of its first official publication. The Law No. 231-VIII was published on November 18, 2025, i.e. it shall enter into force on January 18, 2026. Amendments were introduced to the Rules for the Implementation of Measures for Protection of PD by the Owner and/or Operator, as well as by a Third Party Amendments to the Rules for the Implementation of Measures for Protection of PD by the Owner and/or Operator, as well as a Third Party, approved by Order No. 179/НҚ of the Minister of Digital Development, Innovation and Aerospace Industry of Kazakhstan dated June 12, 2023 were made by the Order No. 672/НҚ of the Deputy Prime Minister – Minister of AI and Digital Development of Kazakhstan dated December 22, 2025 (the “Order”). Specifically, a rule was introduced to the effect that when working with limited-access PD biometric authentication tools shall be used for a database containing more than 100,000 PD records. The Order shall come into effect 10 calendar days after the date of its first official publication. The Order was published on December 26, 2025, i.e. it shall come into effect on January 6, 2025.

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.  

On December 27, 2024, the President of the Republic of Uzbekistan, Shavkat Mirziyoyev, signed the Law "On Telecommunications" No. LRU-1015 (the "Telecommunication Law"), which came into force on December 28, 2024. With the adoption of the new edition of the Telecommunication Law, the previous version, dated August 20, 1999, was repealed. General Provisions The new edition of the Telecommunication Law introduces new legal terms, such as communication line, tariff plan, telecommunication infrastructure (passive telecommunication infrastructure), telecommunication equipment, user devices, and others. The responsible government bodies for regulating the telecommunication sector have been identified The new edition of the Telecommunication Law, among others, lists the following authorities of the Cabinet of Ministers of the Republic of Uzbekistan ("Uzbekistan"): Implementing measures to expand the types of telecommunication services provided and modernize telecommunication infrastructure Taking measures to introduce modern technologies for the protection of telecommunications infrastructure, Determining the procedures and conditions for issuing licenses and permits, as well as the procedures for conducting competitive bidding (tenders) for the issuance of licenses for specific types of activities, Designating the regulatory authority in the telecommunication sector (the "Regulatory Authority"), Approving national programs in the telecommunications sector and ensuring their implementation. The new edition of the Telecommunication Law also designates the Ministry of Digital Technologies as the responsible government body in the telecommunication sector. In addition to other responsibilities, it performs the following functions: Implementing a unified state policy in the telecommunication sector, Developing state and other programs in the telecommunication sector, Drafting legal acts within its authority in the telecommunication sector, as well as regulatory documents related to the technical regulation of telecommunication activities, Organizing certification of telecommunication equipment, Coordinating the activities of operators and providers to ensure the information security of telecommunication networks, Collaborating with relevant authorities to monitor unauthorized access to networks and the circumvention of protection measures during traffic transmission, Promoting international cooperation in the telecommunication sector. Additionally, the Telecommunications Law establishes the authority responsible for state control in the telecommunication sector, specifically the Inspection for Telecommunications Informatization Control (the "State Control Authority"). Its responsibilities include ensuring: Compliance with laws, regulatory documents, and national standards in the telecommunications sector, Protection of user rights and the maintenance of service quality within its scope, Implementation of measures to develop telecommunication networks and services. The State Control Authority has the right to conduct investigations and audits of operators and providers (without interfering in their financial and economic activities) on matters within its scope, based on an order from the head of the State Control Authority to carry out the investigation and audit. The new edition of the Telecommunication Law also outlines the responsibilities of the new the Regulatory Authority — an independent legal entity in terms of finance, structure, and management, responsible for regulating the telecommunications sector. Among its duties are: Licensing and approval procedures for legal entities in the telecommunication sector, Accrediting legal entities that conduct expert evaluations of project documentation for the construction of telecommunication networks and facilities, Regulating tariffs for specific types of telecommunication services, as well as for interconnection services, Defining the list of universal services and their quality requirements, Developing and approving the procedure for using address space and determining the domain name system for the national segment of Internet, Implementing mandatory digital labelling of telecommunication equipment, Collaborating with relevant authorities to monitor unauthorized access to networks and circumvention of protection measures during traffic transmission, Monitoring the compliance of telecommunications services with the established quality requirements and standards. As of today, the Cabinet of Ministers of Uzbekistan has not yet designated the legal entity responsible for the functions of the Regulatory Authority. The new edition of the Telecommunication Law clarifies the procedures for providing telecommunications services The new edition of the Telecommunication Law establishes that no license is required to provide data transmission services in public access points, including those owned by small businesses in rural areas, as well as for local, long-distance, and international communication services. Notably, no license is required when data transmission networks are used exclusively for the internal needs of the companies. This applies, in particular, to manufacturing and technological processes, as well as signal transmission in course of providing the financial services, including banking, payment systems, payment organizations, and e-commerce platforms. At the same time, for certain types of telecommunication activities, licenses may be issued on a competitive (tender) basis. The rules for conducting such competitions will be established by the Cabinet of Ministers of Uzbekistan. Telecommunication network operators and providers are required to offer universal communication services to all users without exceptions or restrictions, ensuring that the quality of these services meets the established standards. The list of universal services and quality requirements will be determined by the Regulatory Authority. The responsibilities for ensuring telecommunication infrastructure during the design of buildings and structures have been defined Furthermore, it is important to note that the new edition of the Telecommunication Law stipulates that the Ministry of Construction and Housing and Communal Services of Uzbekistan, in collaboration with relevant national executive and local authorities, must ensure the following requirements during the development and approval of design tasks and project documentation for public, administrative, residential, and industrial buildings: Allocation of appropriate spaces and engineering infrastructure for the installation of telecommunication equipment in buildings, with provision of power supply, Availability of low-voltage cable shafts inside buildings for laying cables for telephony networks, data transmission, the Internet network, systems for collective reception of cable and terrestrial television, as well as "smart home" and security alarm systems, Allocation of appropriate land plots for the installation of communication lines and telecommunication equipment in public, administrative, residential, and industrial areas, Inclusion of mobile network base stations in regional and district centers, as well as central nodes of operators and providers of telecommunications, and broadcasting facilities in the list of objects exempt from power supply cuts. Mandatory requirements for ensuring telecommunication infrastructure in buildings and the rights of operators to access the telecommunication services have been established New requirements have been established, stipulating that the construction and commissioning of public, administrative, residential, and industrial buildings are not allowed without prior installation of the necessary telecommunication equipment. This includes: Laying cable ducts, Installing low-voltage cable shafts, Designating spaces for placing telecommunication equipment and other infrastructure elements that ensure access to telecommunication services. Operators and providers are authorized to construct communication cable lines throughout the territory of Uzbekistan. They may lay cables underground or suspend them on power line supports and high-voltage lines, in compliance with the requirements set forth by regulatory acts and technical standards. Measures for managing telecommunication during emergency situations have been established In the event of natural or man-made emergencies, or during the declaration of a state of emergency, when human casualties, health damage, environmental harm, significant material losses, or disruption of normal living conditions occur or may occur, the Regulatory Authority has the right to: Use with priority the telecommunication infrastructure, Coordinate centrally the efforts to restore and maintain the functioning of telecommunication networks, Restrict or suspend the operation of telecommunication systems if necessary to prevent further consequences or to mitigate already occurring consequences. The rights and responsibilities of operators, providers, and users in the telecommunications sector were expanded The new edition of the Telecommunication Law significantly expands the rights and responsibilities of operators, providers, and users. Specifically, the following new provisions have been added to the existing rights of operators and providers: The right of operators and providers to jointly use telecommunication infrastructure, communication channels, and radio frequency spectrum on a contractual basis, The provision of specific tariff plans and benefits to a designated group of users or in a specific limited region, The right to challenge, in accordance with the law, unlawful decisions, actions, or inactions of state authorities, unjustified interference in the telecommunication services market, hindrance to free market relations and competition, and to protect their interests. The new obligations for operators and providers include: The requirement to publish in the public domain methods for assessing the quality of services provided, The continuous development and expansion of their networks in accordance with legislation, licensing requirements and conditions, in coordination with the authorized state authority. The free provision of information about the services they offer, as well as the free acceptance of subscribers’ inquiries through a subscriber support center and ensuring their examination.

On December 27, 2024, in pursuance of the Roadmap for the Elimination of Corruption Risks identified in the operation of SK-Pharmacy LLP and the Action Plan approved based on the results of the audit by the Supreme Audit Chamber, the Minister of Health of the Republic of Kazakhstan issued the Order No. 112 (the "Order No. 112"), which introduced amendments and additions to the Order No. 110 dated June 7, 2023 (the "Order No. 110") "On the Approval of the Rules for the Organization and Implementation of the Procurement of Medicines, Medical Devices, and Specialized Therapeutic Products within the Framework of the Guaranteed Volume of Free Medical Care, Additional Volume of Medical Assistance for Persons Held in Pre-Trial Detention Centers and Facilities of the Penal (Penitentiary) System, at the Expense of Budgetary Funds and/or within the Compulsory Social Medical Insurance System, as well as Pharmaceutical Services" (the "Rules"). The amendments regulate procedures for procurement of Medicines ("Medicines"), Medical Devices ("MD"), and Specialized Therapeutic Products within the frameworks of the Guaranteed Volume of Free Medical Care, Additional Volume of Medical Care, and pharmaceutical services. Specifically, the Rules have been amended as follows: Amendments to Tender Rules Aimed at Promotion of Competition The amendments are aimed at eliminating anti-competitive rules which provided an opportunity to recognize a potential supplier as the winner when only one application for participation in a tender (bid) for Medicines and MD was received, as well as preventing the selection of winners based on the application (bid) of only one participant and collusion between procurement participants. The rules for determining a tender winner when one application has been received have been amended. Now, a potential supplier in the absence of competition for the lot shall be recognized as the winner when the repeated purchase for failed lots of Medicines and MD has been carried out (previously, a potential supplier in the absence of competition for the lot was recognized as the winner), with the exception of the purchase of medical equipment which does not have registered analogues in the Republic of Kazakhstan (“Kazakhstan”)1. A provision has been added according to which when purchase of medical equipment is carried out by the lessor, a potential supplier whose application (bid) has been recognized by the commission as meeting the terms of the announcement and the terms of the Rules, in the absence of competition for the lot shall be recognized as the winner (previously - when carrying out a repeated purchase of medical equipment for failed lots, the potential supplier whose application (bid) was recognized as meeting the terms of the announcement and the Rules was considered to be the winner) 2. A new ground for recognizing a tender as failed has been added: receipt of a single application (bid). A tender or any of its lots shall be deemed to have failed in the event of the submission of a single bid for the lot, except for the case provided for in paragraph 197 of the Rules (a potential supplier in the absence of competition for the lot shall be deemed a winner in the course of a repeated purchase for failed lots of Medicines and MD; when purchase of medical equipment is carried out by a lessor, a potential supplier in the absence of competition for the lot shall be deemed to be the winner)3. Amendments have been introduced to the rules for carrying out procurement after a tender or any of its lots have been declared as failed. If a tender or any of its lots has been declared as failed, it is allowed to change the content and terms of the tender, with the exception of the procurement of medical equipment, and to conduct procurement of Medicines and MD from a domestic or foreign manufacturer (previously - conduct procurement by request for quotations, tender, through a single source from domestic or foreign manufacturers, international organizations established by the United Nations)4. Amendments to the Provisions on Changing the Price of a Supply Contract The rules for changing the contract price in connection with changes in maximum prices by the authorized body have been amended. A rule has been introduced according to which in case of a change of the maximum price for the international non-proprietary name (“INN”) and/or trade name (“TN”) of a Medicine and/or MD during the performance of a supply contract (standard supply contract between the SD and the supplier, standard contract for the purchase of goods between the customer and the supplier, standard contract for the provision of pharmaceutical services between the customer and the supplier) the contract remains in force at the previous price until the parties have fully fulfilled their obligations5. The provisions that, in the event of a reduction in the maximum price during the performance of a supply contract, the SD shall conduct negotiations with the supplier to reduce the price of the supply contract as well as the provisions that, in the event of disagreement regarding the reduction in the price of the supply contract or the supplier’s refusal to conduct negotiations, the SD has a right to terminate the supply contract and conduct the procurement in the manner established by the Rules have been excluded6. Amendments into Certain Terms of Template Contracts Some conditions of the template contract for the purchase of goods have been amended. Now the available form of payment is a transfer only (previously - also in cash, through letter of credit and other payments)7. Now the quality guarantee provided by the supplier is valid for one year after delivery of the entire batch of goods or its part (previously - for an agreed number of days after delivery of the entire batch of goods or its part)8. Now the penalty is charged for each overdue day and is calculated based on the cost of goods not delivered or delivered in violation of the delivery schedule (previously, there was no clarification that the penalty is charged for each overdue day)9. Amendment have been made to the template long-term contract for the supply of Medicines and/or MD. Specifically, the supplier’s right to refuse to supply the goods upon provision of a justification to the SD after the start of the supply period before signing the additional agreement to the contract, but not for more than 2 (two) years in a row has been excluded, and also the provision has been excluded stating that if the supplier refuses to supply (the goods) for the relevant financial year after it provides the notification of the start of the supply period, then the specified year of supply shall be included in the supply period10. The following ground for termination of a long-term contract for the supply of Medicines and/or MD has been omitted: the supplier’s failure to comply with the investment project implementation schedule for a period exceeding 12 (twelve) months 11. Certain conditions of the template contract for the provision of pharmaceutical services have been amended 12. For example, a provision has been added stating that the advance payment shall be withheld monthly based on the volume of services rendered 13, as well as the provision that the supplier shall not be subject to VAT for the Medicines purchased under the contract14. The Rules for Procurement by Customers have been Amended Amendments aimed at procurement by the Customers to be carried out through the Single Distributor have been introduced: A provision has been added stating that the Customers shall carry out the procurement of Medicines and MD not included in the list of the Single Distributor (the "SD") through the SD in accordance with Chapters 1 (a tender organized via a web portal), 3 (purchase from a single source via a web portal), 4 (special procurement), 4-1 (purchase by request for quotations) of Section 3 of the Rules15. A deadline by which the SD shall carry out purchases based on SD list has been clarified. Specifically, the SD annually no later than May 1 shall carry out the purchase of Medicines and/or MD6. The Procedure for Purchasing from Domestic or Foreign Manufacturers, Purchasing through Receiving Quotations has Changed The procedure for purchasing from domestic or foreign manufacturers17. Such a ground for termination of a supply contract with a domestic or foreign manufacturer as registration in Kazakhstan of analogs of Medicines and/or MD under the same INN name (composition) and characteristics (when purchasing Medicines and/or MD which do not have registered analogs in Kazakhstan) has been omitted18. In addition, such a ground for purchasing Medicines and/or MD from domestic or foreign manufacturers as the purchase of Medicines and/or MD which do not have registered analogs in Kazakhstan in terms of INN (composition) and/or characteristics has been omitted 19. Amendments to the procedure of purchasing Medicines and/or MD through receiving quotations have been introduced 20. For example, the grounds for purchase through requesting quotations have changed21. The deadline for publishing an announcement for a purchase by requesting quotations has changed - now it is set at no later than 3 business days before the deadline for submitting quotations ends (previously – no later than 7 calendar days)22. The provision that a request for quotations shall be requested from at least two unaffiliated potential suppliers has been omitted23. The rules have been introduced that a purchase by request for quotations shall be considered to have failed if no quotations have been submitted by suppliers, and that if a purchase by request for quotations is considered as failed, repeated purchase shall be carried out through request for quotations or tender [24]. A provision has been added that if a foreign manufacturer has an authorized representative within the territory of Kazakhstan, then they shall provide a certificate of an authorized representative and a regulation on an authorized representative 25. Amendments to the Rules on Carrying out Competition for Concluding Long-Term Supply Contracts among Potential Suppliers Intending to Create and/or Modernize the Manufacturing of Medicines and/or MD (for legal entities registered in Kazakhstan) The procedure for forming the list of Medicines and/or MD has been changed and the timeframes for reviewing the list by the formulary commission have been defined. Specifically, the draft list of Medicines and MD shall be formed on the basis of the analysis of the need for Medicines and MD of the healthcare system conducted by a scientific organization in the field of healthcare, no later than December 5 shall be reviewed by the formulary commission annually by January 3126. The grounds and criteria for issuing an industry opinion have changed. Now the industry opinion shall be issued only on the basis of a feasibility study (previously – also on the basis of a business plan) according to the following criteria: 1) market and industry analysis; 2) social aspects; 3) economic aspects27. The criteria for assessing an application to establish manufacturing of Medicines and/or MD have changed. Now one of the criteria is the provision of an expert opinion (previously a state expert opinion) on the design and estimate documentation for construction28. Further, a new criterion has been introduced – the share of local content [29]. The criteria for assessing an application submitted by a potential supplier intending to modernize the manufacturing of Medicines and/or MD have changed. Now, the experience of more than five years in pharmaceutical manufacturing in Kazakhstan of the founder (shareholder) of the potential supplier is not included in the criteria for evaluating the application of the potential supplier [30]. Further, a new criterion has been introduced – the share of local content31. New obligations for the supplier have been introduced for creation, modernization of the manufacturing of Medicines and/or MD. Specifically, the supplier is obliged to submit a semi-annual report on the progress of the Investment Project and on the process of product registration to the SD; is obliged to fill in the information reflecting the indicators of the manufacturing capacity and its main characteristics [32]. Purchase of Medical Equipment through Financial Leasing has been introduced The rules on the purchase of medical equipment by the lessor have been introduced: Chapter 12 “Purchase of medical equipment by the lessor” has been added to the Section 3, and the list of definitions has been expanded, for example, the definitions of “lessor”, “financial leasing agreement”, etc. have been included33; A provision has been introduced that the purchase of medical equipment by the lessor shall be carried out in paper form until September 30, 2025>[34]; A rule has been introduced that medical equipment costing from KZT 5,000,000 (five million) up to KZT 200,000,000 (two hundred million) may also be purchased using borrowed and/or the lessor’s own funds based on the applications submitted by healthcare entities35. Investment Agreements A provision has been introduced concerning investment agreements covering MD. Namely, within the framework of the implementation of the investment agreement the procurement of MD shall be carried out in accordance with the terms of the concluded investment agreement 36. The Order No. 112 entered into force on January 11, 2025. 1 p. 197 of the Rules as amended on 11.01.2025; p. 197 of the Rules as amended on 07.06.2023; 2 p. 197 of the Rules as amended on 11.01.2025; 3 sp. 4, p. 198 of the Rules as amended on 11.01.2025; 4 p. 210 of the Rules as amended on 11.01.2025 and of the Rules as amended on 07.06.2023;; 5 p. 259 of the Rules as amended on 11.01.2025 and of the Rules as amended on 07.06.2023; 6 p. 259 of the Rules as amended on 11.01.2025 and of the Rules as amended on 07.06.2023; 7 p. 5 of the Annex 5 of the Rules as amended on 11.01.2025 and of the Rules as amended on 07.06.2023; 8 p. 21 of the Annex 5 of the Rules as amended on 11.01.2025 and of the Rules as amended on 07.06.2023; 9 p. 31 of the Annex 5 of the Rules as amended on 11.01.2025 and of the Rules as amended on 07.06.2023; 10 p. 16 of the annex 21 of the Rules as amended on 07.06.2023; 11 sp. 5, p. 20 of the annex 21 of the Rules as amended on 07.06.2023; 12 annex 6 of the Rules as amended on 11.01.2025; 13 p. 5 of the annex 6 of the Rules as amended on 11.01.2025; 14 p. 10 of the annex 6 of the Rules as amended on 11.01.2025; 15 p. 5-2 of the Rules as amended on 11.01.2025; 16 p. 126 of the Rules as amended on 11.01.2025; 17 p. 211 of the Rules as amended on 11.01.2025; 18 sp. 1, p. 226 of the Rules as amended on 07.06.2023; 19 sp. 1, p. 211 of the Rules as amended on 11.01.2025 of the Rules as amended on 07.06.2023; 20 Chapter 4-1 of the Rules as amended on 11.01.2025; 21 p. 245-1 of the Rules as amended on 11.01.2025; 22 p. 245-3 of the Rules as amended on 11.01.2025; p. 74 of the Rules as amended on 07.06.2023; 23 p. 73 of the Rules as amended on 07.06.2023; 24 p. 245-5, 245-6 of the Rules as amended on 11.01.2025; 25 пп. 2, п. 215 of the Rules as amended on 11.01.2025; 26 p. 266 of the Rules as amended on 11.01.2025; 27 p. 295 of the Rules as amended on 11.01.2025; 28 sp. 3, p. 301 of the Rules as amended on 11.01.2025, sp. 3, p. 301 Rules as amended on 07.06.2023; 29 sp. 7, p. 301 of the Rules as amended on 11.01.2025; 30 sp. 2, p. 302 of the Rules as amended on 11.01.2025; 31 p. 8, 302 of the Rules as amended on 11.01.2025; 32 p. 322-1, p. 322-2 of the Rules as amended on 11.01.2025; 33 sp. 70, 69, p. 2 of the Rules as amended on 11.01.2025; 34 p. 5-1 of the Rules as amended on 11.01.2025; 35 p. 99-1 of the Rules as amended on 11.01.2025; 36 p. 454 of the Rules as amended on 11.01.2025.

By the Order of the Minister of Health of the Republic of Kazakhstan (“RK”) dated December 25, 2024 No. 110 (the “Order No. 110”) amendments have been made to the Rules for Regulation,Formation of Maximum Prices and Markups for Medicines as well as Medical Devices (“MD”) within the Framework of the Guaranteed Volume of Free Medical Care (“GVFMC”) and/or in the Obligatory Social Medical Insurance System (“OSMI”) approved by the Order of the Minister of Health of the RK dated December 11, 2020 No. ҚР ДСМ-247/2020 (the “Rules”). The following changes have been made to the Rules for Regulation, Formation of Maximum Prices and Markups on Medicines (the “Pricing Rules for Medicines”): The change in the concept of the Registered Price for Wholesale and Retail Sales, which previously included, among other things, also marketing costs, in the present version includes only the maximum price of the manufacturer[1]; Change in the concept of the Registered Price within the Framework of the GVFMC and/or OSMI, which now does not include the costs of quality assessment, and for imported Medicines - transportation costs from the manufacturer to the border of the RK and customs duties[2]; Changes in the list of reference countries, namely the inclusion of Kyrgyzstan, Uzbekistan, and the exclusion of Greece, Lithuania, Latvia, Romania, Slovakia, Croatia, Czech Republic, Estonia[3]; Omission of the provision establishing confidentiality of the information provided by the applicant for registration of the price or re-registration of the registered price[4]; Omission of the provision on currency adjustment of the price in KZT when registering or re-registering a registered price[5]; The list of documents which domestic manufacturers attach to the application for price registration or re-registration of the registered price for wholesale and retail sales has changed, namely: there is no need to provide information on actual expenses incurred for wholesale and retail sales on the applicant's letterhead[6]; the following documents have been added: information with supporting documents (contract, agreement) on the prices of the Medicine sold in other countries for the past 12 months preceding the date of filing an application for registration or re-registration of the Medicine (in the absence of sales in other countries, the applicant confirms the absence of sales on the applicant's letterhead certified by the signature of the authorized person of the applicant), a copy of the document confirming the existing patent protection of the original medicinal product or a biological original medicinal product by INN indicating the expiration date of the patent protection[7]; The list of documents which foreign manufacturers attach to the application for price registration or re-registration of the registered price for wholesale and retail sales has changed, namely: there is no need to provide information on actual expenses incurred for wholesale and retail sales of Medicines[8]; now foreign manufacturers will need to provide a copy of the document confirming the existing patent protection of the original medicinal product or a biological original medicinal product based on the INN, indicating the expiration date of the patent protection[9]. The criteria for registering the price or re-registering the registered price of a Medicine manufacturer for wholesale and retail sales have changed, namely, the provided manufacturer's price for imported Medicines for the RK shall not exceed the highest of the three lowest prices from among submitted in the application reference countries (previously did not exceed the average value of Ex-Works prices in reference countries)[10]; if the number of reference countries is less than three, the manufacturer's price shall not exceed the highest price value from the provided number of reference countries[11]; the provided maximum price of the manufacturer for imported Medicines shall not be higher than the price value (previously not higher than the maximum price value)[12] specified in the provided documents confirming the price of the Medicine in the contract or agreement for the purchase of Medicines[13]; the requirements for marketing and transportation costs have been omitted, and a new criterion has been added, namely, “the maximum price provided by the domestic manufacturer shall not exceed the Medicine prices in other countries” [14]; Wholesale and retail markups on Medicines, wholesale and retail markups on Medicines under a special procedure have changed: wholesale markups – from 25% to 10%[15] (in the previous version from 21% to 10%[16]), wholesale markups under a special procedure – from 10% to 5,5%[17] (in the previous version from 10,5% to 5%[18]), retail markups - from 30% to 10%[19] (in the previous version from 55% to 10%[20]), retail markups under a special procedure -  from 15% to 5%[21] (in the previous version from 27,5% to 5%[22]). A rule has been introduced to the effect that the maximum price for the trade name of a Medicine for wholesale and retail distribution for a generic Medicine or biosimilar Medicine shall be below the maximum price for the trade name of an original medicinal product or biological original medicinal product, for a generic Medicine– by 30%, for a biosimilar Medicine – by 10%[23]. Price Registration within the framework of the GVFMC and/or OSMI The list of documents which domestic manufacturers attach to the application for price registration or re-registration of the registered price within the framework of the GVFMC and/or OSMI has changed, namely: The following documents have been added: information with supporting documents (contract, agreement) on the prices of Medicines sold in other countries for the past 12 months preceding the date of filing an application for registration or re-registration of the Medicine, a copy of the document confirming the existing patent protection of the original Medicine by INN indicating the expiration date of the patent protection, the requirement to provide information on expenses has been omitted [24]. Requirements have been changed for the documents which contract manufacturing customers attach to the application for price registration or re-registration of the registered price within the framework of the GVFMC and/or OSMI, for example, the requirement to provide information on actual expenses incurred has been omitted; a requirement has been added to provide a copy of a document confirming the existing patent protection of the original medicinal product by INN, indicating the expiration date of the patent protection, a requirement to provide information on prices in reference countries, in case of absence of prices in reference countries, information on prices in the country of the manufacturer has been added[25]; The list of documents which foreign manufacturers attach to the application for price registration or re-registration of the registered price within the framework of the GVFMC and/or OSMI has changed, namely: a provision has been added to the effect that in the absence of actual imports over the past 12 months, copies of documents for the previous 12-month period shall be provided, and in the absence of actual imports for the specified period the applicant confirms the absence of imports on the applicant's letterhead, certified by the signature of the applicant's authorized person[26]; a requirement to provide information on actual expenses incurred has been omitted[27]. The criteria for registering the price or re-registering the registered price of a Medicine within the framework of the GVFMC and/or OSMI system have changed, namely: Exclusion of the criterion that transportation costs from the manufacturer to the border of the RK, specified in the application shall not exceed 15% of the manufacturer’s price within the framework of GVFMC and/or OSMI system[28]. Adding a criterion that the maximum price of a domestic manufacturer's Medicines within the framework of the GVFMC and/or in the OSMI shall not exceed the prices of Medicines sold in other countries[29]; The markups within the framework of the GVFMC and/or the OSMI system for Medicines have changed, in the present version – from 20% to 10% (in the previous version – from 20% to 14%)[30]. The markups for Medicines within the framework of the GVFMC and/or the OSMI system under the special procedure have changed - in the present version from 10% to 5% (in the previous version from 10% to 7%)[31]; A provision has been added stating that the draft maximum price for a trade name of a Medicine within the framework of the GVFMC and/or in the OSMI system shall not be higher than the approved maximum price for a trade name of a Medicine for wholesale sales[32]; A rule has been introduced stating that the maximum price for the trade name of a Medicine within the framework of the GVFMC and/or in the OSMI system for a generic Medicine or a biosimilar Medicine shall be lower than the maximum price for the trade name of the Medicine of the original or biological original medicinal product, for a generic Medicine – by 30%, for a biosimilar Medicine – by 10%[33]; The provision has been omitted to the effect that during the formation of the draft maximum prices within the framework of the GVFMC and/or the OSMI system if it is observed that the maximum prices are higher by 10 percent or more compared to the approved maximum prices for Medicines, the state expert organization conducts an analysis of prices based on the manufacturer's price, import prices, costs and according to data from the official websites of authorized bodies in reference countries with a similar INN, taking into account the dosage, concentration, volume and packaging of the Medicine[34]. The Rules for Regulation, Formation of Maximum Prices and Markups on MD within the Framework of the GVFMC and/or the OSMI System (the “Pricing Rules for MD”) Amendments include the following: It has been established that price regulation applies to a trade name and technical characteristics of Medical Supply (“MS”) as well as to Medical Devices for diagnostics outside a living organism (in vitro) manufactured in the territory of the RK within the framework of long-term contracts with a Single Distributor (“MD in vitro”)[35]; The definition of reference countries has been omitted[36]; Now to register the price or re-register the registered price for a MS within the framework of the GVFMC and/or in the OSMI for the trade name of the MS information on the actual supply price is provided indicating a link to the procurement web portal of SK-Pharmacy LLP, a link to the state procurement web portal with the provision of supporting documents (protocol, procurement agreement and/or supply agreement) of the last purchase within the 12 months preceding the date of application submission[37]; The provision that the information provided by the applicant for the purpose of price formation shall be confidential has been omitted[38]; A list of documents for registering the price or re-registering the registered price of a MS within the framework of the GVFMC and/or the OSMI system for domestic manufacturers has been determined[39]; When registering or re-registering the price of MS the requirement to provide information on the actual costs incurred has been omitted for foreign manufacturers as well as the requirement that the total costs incurred shall not exceed 25% of the manufacturer’s Ex Works price[40]; The criteria for registering the price or re-registering the registered price of MS within the framework of the GVFMC and/or the OSMI system have been changed, namely: the criterion has been omitted stating that the manufacturer's price within the framework of the GVFMC and/or in the OSMI system for imported MS shall not exceed the maximum value of three minimum Ex-Works prices from among submitted in the application reference countries[41]; New criteria have been introduced, namely, the maximum price for MS of a domestic manufacturer within the framework of the GVFMC and/or the OSMI system shall not exceed the prices of MS sold in other countries, the registered price within the framework of the GVFMC and/or in the OSMI shall not exceed the price of the last purchase on the web portal of SK-Pharmacy LLP, on the public procurement web portal within the 12 months preceding the date of filing the application for the MS[42]. Markups for MS under the GVFMC and/or the OSMI system have been reduced, in present version - -from 20% to 10% (in the previous version- from 33% to 20%)[43]; The list of documents to be provided for an analysis of prices for in vitro MD has been established[44]. The Order No. 110 enters into force on January 7, 2025, except for the provisions stating that: when registering or reregistering prices for Medicines the state expert organization compares the data provided by the applicant for compliance with the requirements of the Pricing Rules for Medicines and data from the integrated information system of customs authorities; the maximum price for the trade name of a Medicine for retail sale shall not be higher than the average prices in pharmacy chains indicated in the integrated information system of the authorized state revenue body based on cash receipts,which come into effect on July 1, 2025[45]. Footnotes [1] sp. 14, p. 2 of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63, sp. 14, p. 2 of the Pricing Rules for Medicines as amended by the Order No. 110; [2] sp. 27, p. 2 of the Pricing Rules for Medicines as amended by the Order No. 110; [3]sp. 23, p. 2 of the Pricing Rules for Medicines as amended by the Order No. 110; [4] p. 11 of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63; [5] p. 10 of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63; [6]. p.18 of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63; p. 18 of the Pricing Rules for Medicines as amended by the Order No. 110; [7] sp. 2, 3, p. 18 of the Pricing Rules for Medicines as amended by the Order No. 110; [8] p. 18 (for foreign manufacturers) of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63; [9] sp.5, p. 18 (for foreign manufacturers) of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63; [10] sp. 1, p. 24 of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63; [11] sp. 1, p. 24 of the Pricing Rules for Medicines as amended by the Order No. 110; [12] sp. 3, p. 24 of the Pricing Rules for Medicines as amended by the Order No. 110; [13] sp. 3, p. 24 of the Pricing Rules for Medicines as amended by the Order No. 110; [14] p. 24 of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63, of the Pricing Rules for Medicines as amended by the Order No. 110; [15] p. 27 of the Pricing Rules for Medicines as amended by the Order No. 110; [16] p. 29 of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63, [17] p. 28 of the Pricing Rules for Medicines as amended by the Order No. 110; [18] p. 30 of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63, [19] p. 33 of the Pricing Rules for Medicines as amended by the Order No. 110; [20] p. 34 of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63, [21] p. 34 of the Pricing Rules for Medicines as amended by the Order No. 110; [22] p. 35 of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63, [23] p. 30, 36 of the Pricing Rules for Medicines as amended by the Order No. 110; [24] p. 47 of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63, of the Pricing Rules for Medicines as amended by the Order No. 110; [25] p. 47 (for contract manufacturer customers) of the Pricing Rules for Medicines as amended by the Order No. 110; [26] sp. 2, p. 47 (for foreign manufacturers) of the Pricing Rules for Medicines as amended by the Order No. 110; [27] p. 47 (for foreign manufacturers) of the Pricing Rules for Medicines as amended by the Order No. 110; [28] sp. 3, p. 53 of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63, p. 51 of the Pricing Rules for Medicines as amended by the Order No. 110; [29] sp. 4, p. 51 of the Pricing Rules for Medicines as amended by the Order No. 110; [30] p. 54 of the Pricing Rules for Medicines as amended by the Order No. 110; p. 58 of the Pricing Rules as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63; [31] p. 55 of the Pricing Rules for Medicines as amended by the Order No. 110; p. 59 of the Pricing Rules as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63; [32] p. 54 of the Pricing Rules for Medicines as amended by the Order No. 110; [33] p. 58 of the Pricing Rules for Medicines as amended by the Order No. 110; [34] p. 61 of the Pricing Rules for Medicines as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63, [35] p. 5 of the Pricing Rules for MD as amended by the Order No. 110; [36] p. 3 of the Pricing Rules for MD as amended by the Order No. 110; [37]sp 3, 4 (for domestic manufacturers), sp5, 6 (for foreign manufacturers), p. 14 of the Pricing Rules for MD as amended by the Order No. 110; [38] p. 7 of the Pricing Rules for MD as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63; [39] p. 14 of the Pricing Rules for MD as amended by the Order No. 110; [40] p. 14 (for foreign manufacturers) of the Pricing Rules for MD as amended by the Order No. 110; [41] p. 20 of the Pricing Rules for MD as amended by the Order No. 110; [42] sp. 3, 4, 5, p. 20 of the Pricing Rules for MD as amended by the Order No. 110; [43] p. 21 of the Pricing Rules for MD as amended by the Order No. 110; p. 20 of the Rules as amended by the order of the Acting Minister of Health of the RK dated 20.08.2024 No. 63; [44] p. 29, 36 of the Pricing Rules for MD as amended by the Order No. 110; [45] p. 4 the Order No. 110;