Vakhidov & Partners

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 With the adoption of the new edition of the Telecommunication Law, the previous version, dated August 20, 1999, was repealed.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;