Licensing Procedures Research Articles

Tackling the Burden of Substandard and Falsified Medicines and Health Technologies in Somaliland and Somalia

Background: The problem posed by the substandard and falsified (SF) medicines is a rising global challenge. WHO estimates that sales of SF medical products in low- and middle-income countries is around US$ 30 billion whereby 1 in 10 medical is substandard or falsified. Objectives: The purpose of this article was to enlighten the actions by the Somali NRA to tackle the scourge of SF medicines in Somalia. Methods: The literature was reviewed on the topic and evidence from other sources were incorporated including reports of post-marketing surveillance surveys, assessments at national and regional levels, as well as author’s experiences. Findings: The medicines regulatory capacity is weak in Somaliland and Somalia, where only 16% of total indicators for the regulatory system was in place as per WHO/IGAD rapid benchmarking of the National Regulatory Authority (NRA) in 2017, increasing the risk of circulation of SF medicines in the local private sector dominated and exclusively import relied pharmaceutical supply chain. Key actions by the NRA to address this problem include: regulatory reliance mechanisms such as using the WHO PQ/EUL for emergency authorization of vaccines, i.e. COVID-19 vaccines, enhanced licensing procedures, information exchange with NRAs in the region as well as technical collaboration with WHO. Conclusion & Recommendation: However, a lot has to be done and considering the weak laboratory capacity and the porous national borders, the risk of local circulation of SF medicines is high and swift actions are needed to ensure access to safe and quality medicines and health technologies in Somaliland and Somalia.

PROBLEMS AND PROSPECTS OF THE DEVELOPMENT OF BANKING REGULATION AND SUPERVISION IN UKRAINE

Effective banking regulation and supervision are key factors for ensuring the stability of the national banking system of Ukraine. The purpose of this article is to analyze the peculiarities of banking regulation and supervision in Ukraine in order to identify problems and possible ways of development, including in the context of world experience. The article examines the theoretical aspects of the essence of the concepts of banking regulation and banking supervision. The main indicators of the banking system of Ukraine for 2020-2024 and the mechanism for identifying risks in the activities of banking institutions are also considered. The global trends in banking regulation at the current stage are its centralization, the concept of risk-oriented supervision, the introduction of new financial technologies, the development of the principles of proportional banking regulation. The main positive and negative methods of supervision in the banking sector are singled out. It has been proven that the conditions of a full-scale military conflict significantly undermined the development of the banking system of Ukraine. The destruction of infrastructure, loss of customer confidence, risks to the bank's loan portfolio and capitalization have become major problems. In addition, the decrease in liquidity and the growth of inflation risks create serious challenges for the banking system. The degree of suitability of world models in terms of the priority tasks of the state regarding the regulation of the banking sector is analyzed. Directions for improving banking supervision through improvement of banking activity licensing procedures are proposed; introduction of permanent monitoring of the activities of domestic commercial banks, in particular their financial condition; implementation of constant monitoring of compliance with banking regulations and current legislation; introduction of permanent inspections of banking activities; implementation by commercial banks of ongoing internal control and external audit control; developing and sending supervisory instructions for banking institutions regarding the implementation of Basel III standards.

Legal Review of Ship Certification After the Issuance of Law Number 11 of 2020 Concerning Job Creation

This research examines the shift in authority and processes related to the certification of fishing vessels in Indonesia after the enactment of Law No. 11 of 2020 on Job Creation. The primary objective of this study is to analyze the legal force and implications of the transfer of authority from the Ministry of Transportation to the Ministry of Marine Affairs and Fisheries (KKP) in issuing fish vessel certifications. Using a normative juridical approach, this study investigates the procedural changes, challenges, and impacts of the new regulatory framework on fishing vessel safety and compliance. The findings show that the Job Creation Law simplifies licensing procedures while ensuring the safety and seaworthiness of fishing vessels. However, the study also highlights the challenges posed by a shortage of qualified inspectors, leading to delays in the certification process. This research underscores the need for regulatory adjustments and additional inspector training to align the maritime sector with the law’s goal of promoting safety and business efficiency.

Licensing Procedures’ and its Influence on The Enforcement of Alcoholic Drinks Control and Licensing Policies in Nairobi City County, Kenya

The enactment and subsequent implementation of the alcoholic drinks control policies and legislation in Kenya continues to elicit numerous questions as to the efficiency of the same in achieving the intended purposes. Many illicit brews and alcoholic drinks continue to find their way into the market, many people engaging in them yet they are not only a health risk, but dangerous for human consumption. The question that remains unanswered is whether the licensing procedures for the manufacturers, dealers and even merchants, play a role in the enforcement of these pieces of legislation or not. This research project aimed at how the licensing procedures determine the enforcement of polices within Nairobi City County. The study was guided by street-level bureaucracy theory and was conducted using descriptive research design targeting 112 enforcement officials. Primary data was gathered utilizing a structured questionnaire and interviews with 10 NACADA officials. Data analysis was done using descriptive statistics as well as the regression model. A 62.5% response rate was achieved and the results indicated that the licensing procedures influence alcoholic drinks control policy enforcement by licensing procedures being adhered to when enforcing the County alcoholic drinks control policies, and there are regular checks on licenses for business functions that operate and sale alcoholic drinks. In line with the study's conclusion, the study recommended that there should be continuous monitoring and evaluation and capacity building for the traders and dealers of the drinks

The simplification of licensing procedure in job creation law: the effectiveness to attract foreign investor

The simplification of licensing procedure in job creation law: the effectiveness to attract foreign investor

Implementation of Digital Governance in One-Stop Integrated Licensing Services: A Case Study of the SAMIRINDU-PASTI BEDAS Application in Bandung Regency

This study aims to explain the running of digital governance in one-stop integrated services carried out at the Bandung Regency Investment and One-Stop Integrated Services Office (DPMPTSP) which has been running since the issuance of Regional Regulation Number 15 of 2018 concerning Amendments to Regional Regulation Number 12 of 2016 concerning the Formation and Composition of Regional Apparatus. The research method used in this study is a descriptive research method with a qualitative approach. where the researcher describes the facts about the problem that is the focus and is ringed with accurate interpretation through in-depth interviews. The digital governance model used in this study is the Welchaman Model (2015). The results of this study show that the Bandung Regency Government, through the One-Stop Investment and Integrated Services Office (DPMPTSP), implements an electronic licensing system through the SAMIRINDU - PASTI BEDAS application with the aim of simplifying the licensing process and improving the accessibility of services for the community. This application allows applicants to apply for permits online and print their permits through the application once approved. The digital governance of one-stop integrated services in Bandung Regency has been implemented quite well, but there are several disruptions to the server and a lack of understanding of licensing procedures are obstacles. So that the goal of integrated services, namely fast and precise, has not been achieved optimally.

Nun of the river: The material and spiritual economies of small hydropower in rural Tanzania

This article examines the significance of hydroelectric mini-grids owned and operated by Catholic sisterhoods in rural Tanzania, situating them within a broader context of energy transition and environmental justice. The Tanzanian state is betting that mini-grids can effectively supplement the national grid’s limited reach; since 2010 it has invested considerable effort in developing a regulatory framework that streamlines licensing procedures and specifies feed-in tariffs. Today, the field is wide open and a range of ownership models – community, private, state-owned – are unfolding on the ground with variable results regarding their financial sustainability, environmental impact, and developmental outcomes. Though often overlooked in this discourse, missions, churches, abbeys, and convents have a history of operating run-of-the-river power stations and other off-grid systems that stretches back into the colonial era. Such infrastructures anchor material and spiritual economies of rain, care, and cash that straddle both community and commercially oriented modes of provisioning. Their continued presence suggests that in some ways this new paradigm of decentralized energy provision builds upon long-standing historical logics of patronage and political authority in marginal areas.

A Critical Analysis of the UAE Federal Decree-Law No.: (38) of 2021 on the Protection of Copyrights and Neighboring Rights

Recently, by virtue of Federal Decree-Law No.: (38) of 2021, the United Arab Emirates has passed a new legislation for the protection of copyrights and neighboring rights; a legislation that is meant to replace the prior Copyrights and Neighboring Rights Law No.: (7) of 2002. In this regard, this new Decree-Law is consisted of Fifty-Three (53) Articles; hence, it is somewhat similar to the prior law, except for the addition of some new amendments for certain details as mentioned herein in this paper (e.g. Smart Applications are added to the list of Digital Works).For instance, pursuant to this new Decree-Law, it is now impermissible for the author to request cessation of the circulation of his digital works; and that is as an exception to his moral right to withdraw his work from circulation after its publication. In addition, this new Decree-Law has granted people with special needs the right to alter the published work, without prior permission of the author or his successor, so that those people may be capable of using those works in a way that is suitable to their conditions. Furthermore, the new Decree-Law has permitted the formation of a Grievances Committee at the Ministry of Economy, presided by a competent judge; and that is in order to hear all appeals submitted against decrees of the Ministry of Economy, concerning the rejection of works registration, the rejection of works' transcription or translation for scientific purposes, or any other decrees issued by the ministry concerning copyrights and neighboring rights. In this sense, the executive regulation of this new Decree-Law has been issued under No.: (47) of 2022, including Twenty (20) Articles, duly covering the following aspects and procedures: a) the regulation of works' collective management; b) the stated procedures for works registration; c) the legal actions concerning the financial rights of works; d) the stated procedures of mandatory licensing from the Ministry of Economy for the works' transcription or translation for scientific purposes; and e) the stated procedures of appeal against decrees of the Ministry of Economy before the Grievances Committee. The object of research is to critically examine the similarity between the Federal Decree-Law No.: (38) of 2021 on the Copyrights and Neighboring Rights and the previous Law No.: (7) of 2002 on the Copyrights and Neighboring Rights, and to identify the new changes brought by the new legislation. The study reveals that the new law limits the right of the author, granted certain rights to the people with special needs, and provision for formation of the Grievance Committee. The study recommends for the unification of all legislations that relate to intellectual property, and create a separate provision for each type of intellectual property.

Geomorphological Compartmentation of Pereiro Massif and its surroundings, in Northern Northeast of Brazil

The Pereiro Massif (PM), located between the states of Ceará, Rio Grande do Norte and Paraíba, is a granitoid body that occupies an area of ​​approximately 2,200 km2, and and has maximum altitudes of 861 meters. This work aimed to elaborate and discuss the geomorphological compartmentalization of the Pereiro Massif and its surroundings. To this end, the following procedures were followed: 1) bibliographic and cartographic review on the geology and relief of the study area; 2) creation of the geomorphological map in a GIS environment, through SRTM image processing; 3) field activities for mapping conference, obtaining information to characterize the shapes and photographic survey. Fifteen units were mapped and grouped into three dimensions that consider the resulting processes and forms: accumulation, flattening and erosion surfaces. The compartments are classified recognizing processes associated with continental denudation with erosion, transport and deposition of material, based on structural geomorphology. The mapping carried out enhances the scientific notoriety of the PM and is expected to serve for environmental planning actions, such as the creation of protected areas and environmental licensing procedures.

The Development of Family Entrepreneurship in Russia: The Development Prospects and Main Directions of State Policy

Introduction: the paper deals with the analysis of the peculiarities of the legal regulation of family entrepreneurship in the Russian Federation, the identification of current trends in this area, and the discussion of prospects for its development. Both the positive aspects of the existing legislation and possible directions for its modification to stimulate the development of family entrepreneurship are considered. Purpose: to analyze the development of family entrepreneurship in Russia and identify the prospects for its development. Methods: the methodological framework for the research is based on the methods of scientific cognition, among which the main ones are the methods of consistency, analysis, and comparative law. Results: the study has shown that family business is an important part of the economy, contributing to job creation, increased tax revenues, and regional development. Conclusions: based on the results of the study, it becomes obvious that there is a need to improve the regulatory framework aimed at supporting and developing family entrepreneurship, including simplifying registration and licensing procedures, reducing the tax burden, developing specialized support programs, and stimulating innovation. An important area is also the strengthening of legal guarantees for the protection of the rights of family entrepreneurs, including the protection of intellectual property and ensuring access to due process of law.

Strengthening Global Security: Critique on the NPT and NSG Mechanisms of Nuclear Export Control Regime

An export control regime plays a vital tool in the effort to counter the proliferation of traditional weapons and weapons of mass destruction. However, there are new and fundamental challenges with this system. The article emphasizes the importance of understanding and implementing nuclear export control mechanisms to advance international security and prevent the spread of nuclear weapons. The research will apply descriptive analysis of the mechanisms of nuclear export controls. Critical analysis of the nuclear export control apparatuses will be applied as a technique to review the loopholes in the enforcement mechanisms of these initiatives. The debate covers key aspects of nuclear export control, including legislative frameworks, industry compliance, licensing and authorization procedures, verification and monitoring systems and control scope. Understanding these elements will enable stakeholders to support responsible and peaceful transfers of nuclear technology while ensuring compliance with international commitments and nonproliferation standards. The paper further delves into the context of these regimes, which are constructed in a way that provides cushion to the international community led by the Western states. The article emphasizes the critical role of the mechanisms of nuclear export control in preserving international security by preventing the unauthorized transfer of sensitive nuclear materials and technology. It also emphasizes the need for industry and national collaboration in this regard.

Procedure for licensing medical activities at the present stage: problems and ways to overcome them

BACKGROUND: One of the tools for ensuring the quality of medical care and medical services is licensing procedures for admission to medical activities, which include licensing. Licensing is indicated as a mandatory condition for carrying out medical activities in the list of types of activities for which licenses are required (clause 46 of Article 12 of the Federal Law “On Licensing of Certain Types of Activities”). Since life and health are the most important universal human values and are legally enshrined at the level of the Constitution of the Russian Federation, the study of the healthcare sector, including from the point of view of legal support for procedures for admitting individuals and legal entities to medical activities, is of exceptional scientific and practical interest. It should be noted that the institution of licensing of medical activities is one of the legal institutions that is constantly undergoing legislative changes, which allows us to speak about the relevance and relevance of this issue. Issues of licensing medical activities quite often come to the attention of researchers, however, due to the dynamic changes in the current legislation on the issue under study and the presence of quite extensive judicial practice, they require additional research in order to resolve problematic issues that arise in practice. OBJECTIVE OF THE STUDY: based on an analysis of the regulatory framework for licensing medical activities, to identify problematic procedural issues and determine ways to improve the current legislation regulating the provision of medical care and medical services. MATERIALS AND METHODS: Using the method of expert assessments, an analysis was carried out of the regulatory framework of the Russian Federation regulating legal relations during the procedure for licensing medical activities by organizations of the public and private healthcare system. RESULTS: Licensing as an institution of law is complex in terms of the legal relations it generates, combining at its core the legal norms of two broad branches of law — administrative and civil. At the same time, licensing is a mandatory criterion for the functioning of a medical organization and includes a number of requirements for such organizations. Despite the extensive regulatory framework on the issue under study, licensing requirements contain a number of problematic aspects that create obstacles for licensees and license applicants and require legislative approval. In this regard, the authors have proposed ways to resolve existing contradictions by making specific proposals to change the current legislation. The proposed optimization of the licensing procedure for all participants in this process, as well as minimizing the risks arising from these legal relations, according to the authors, fully meets the objectives of ensuring the rights of citizens to high-quality and safe medical care.

Implementation of Integrated Sub-District Administrative Services Policy (PATEN) in West Kelumpang Sub-District Kotabaru Regency

Human resources (HR) are a crucial element in determining the success or failure of any task. HR managers in agencies have focused on developing strategies to provide the best service to the community through direct services and administrative functions. One key policy in realizing Good Government is the District Integrated Administration Service (PATEN), designed to establish districts as community service centers. In Kelumpang Barat District, Kotabaru City, PATEN has been implemented based on the provisions of Minister of Home Affairs Regulation Number 4 of 2010. This study uses a descriptive qualitative research method, guided by Edwards III’s Policy Implementation theory, which focuses on communication, disposition, resources, and organizational structure. Data was collected through observation, interviews, and documentation, followed by data reduction, display, and verification. The findings highlight that, in Kotabaru City, PATEN services have not yet fully delegated licensing authority to the district level. Only non-licensing services can be managed locally, and applicants must still handle licensing procedures with higher-level agencies. In Kelumpang Barat, however, PATEN has significantly improved service standards and infrastructure. The study concludes that while PATEN has improved public services, there has been no delegation of licensing authority. To avoid overlapping duties and functions, it is recommended that the government focus on a single licensing policy. This will enhance efficiency and streamline the licensing process, further strengthening the district's role as a community service center.

Legal Strategy To Prevent And Overcome Abuse Of Funds In Digital Wallets

E-wallet, or electronic wallet, is an application or software that enables users to store, manage, and conduct financial transactions electronically. E-wallets usage is able for various purposes, such as making payments, transferring money, or storing payment information for online transactions. Despite the advantages of e-wallets, there are still risks associated with their use, such as the potential loss of consumer funds and the possibility of personal data leaks due to inadequate security measures on the platform. It can disadvantage consumers as users of e-wallets. Law Number 8 of 1999 concerning Consumer Protection contains various provisions aimed at directing manufacturers and businesses, especially those in the business sector, to behave in a manner that supports national economic development. Bank Indonesia has implemented a legal protection system for digital wallet users, starting from the issuance of regulations and policies. One such policy is the creation of guidelines for the operation of payment system services, especially for the use of digital wallets. These guidelines are regulated in Bank Indonesia Regulation Number 20/6/PBI/2018, which discusses the operation of payment systems through digital wallets. This regulation, known as the Bank Indonesia Electronic Money Regulation, establishes licensing and supervision procedures for electronic money operations, including the use of digital wallets. Bank Indonesia not only regulates operational procedures but also emphasizes consumer protection for payment system users, including those using digital wallets, by issuing Bank Indonesia Regulation Number 16/1/PBI/2014 concerning Consumer Protection for Payment System Providers.

Digital Transformation in Management Decisions of the Administrative Licensing Procedure in the Russian Federation

One of the forms of realization of public power is managerial decisions that apply to all spheres of public administration. Licensing is the most important administrative procedure. It is aimed at preventing threats and possible damage to economic relations, environmental protection, public health, social relations, defense and security of the state, the potential for which is associated with the implementation of certain types of entrepreneurial activity. This article discusses such a type of management decision, which is aimed at optimizing the management process. Digitalization involves improving and changing the model of the administrative licensing procedure. Special attention is paid to such a digital solution as the implementation of the registry model of a management solution. This made it possible to significantly simplify the administrative licensing procedure, reduce its time, as well as to conduct most of the interaction with the licensing authority remotely. The author notes the positive impact of digital transformation on the management decision-making process in the field of licensing, and also proves that the use of technology has made it possible to increase efficiency and automate most of the management processes in the administrative procedure. In conclusion, the author notes the prospects for the modernization of Russian legislation in the field of licensing and argues for proposals for its improvement.

Optimizing spent nuclear fuel cask loading for VVER-440 fuel

The paper explores the management of spent nuclear fuel, focusing on dual-purpose spent fuel casks used to store and transport spent nuclear fuel from VVER-440 reactors. The main goal is to optimize spent fuel cask loading by developing an extensive methodology supported by a powerful tool. Using a multiple-zoning strategy, cooler outside fuel assemblies protect radiation sources from the hotter inner assemblies. An effective tool based on adjoint particle flux calculations is the recently developed OPOS-440 calculation code. This code allows for optimizing the loading pattern and determining dose rates surrounding the spent nuclear fuel cask for a selected fuel loading. The code also thoroughly demonstrates how different fuel assemblies affect the dose rate. These findings have real-world implications for reactor operations, including optimizing cask loading and supporting the licensing procedure for novel fuel types in already-existing spent fuel casks.

O-123 Trends and challenges in the practice of ART in China

Abstract China is a large country with a population of over 1.4 billion. In 1988, the first in-vitro fertilization-embryo transfer (IVF-ET) baby was born in Peking University Third Hospital. In the following 3 decades, assisted reproductive technology (ART) has developed rapidly in China, and the availability and accessibility of the ART service have improved markedly. In 2004 totally, only 37 institutions had passed the administrative licensing procedure to carry out ART. While in 2020, 536 institutions obtained the ART license. Since 2016, the total number of ART service cycles(Artificial insemination included)has exceeded 1 million, and the number of babies born has exceeded 300,000, accounting for about 2% of the total live births in China in 2016. At present, assisted reproductive technology has become one of the important medical interventions for the treatment of infertility in China, which has brought good news to infertile couples and their families, and has made great contributions to social harmony and family happiness. Cycles per million population (C/M) in 2009 was 120. In 2020, it has increased to 668, with more and more infertile couples having access to this technique in China. The success rate of assisted reproductive technology remained stable. In 2020, the clinical pregnancy rates (CPR)of conventional IVF and ICSI fresh embryo transfer cycles reached 52.4% and 49.4%, respectively, and the live birth rates were 43.0% and 40.6%, respectively. The clinical pregnancy rate and live birth rate of frozen-thawed embryo cycle were 51.3% and 40.5% per transfer. With the widespread application of embryo freezing technology, the cumulative live birth rate was estimated to reach 49.5% (CLBR estimate) in 2020. The safety monitoring indicators of assisted reproductive technology showed that since 2015, the multiple pregnancy rates of conventional IVF, ICSI and FET have decreased year by year, and have dropped to 22.4%, 21.4% and 17.6% in 2020, respectively. The incidence of moderate-severe ovarian hyper-stimulation syndrome (OHSS) and severe bleeding were also under control, within a reasonable range. Assisted reproductive technology, which involves many medical, social, ethical and legal issues, is a special clinical technology with limit application for medical indication. The Chinese government attaches great importance to the quality and safety management of assisted reproductive technology. A series of management documents such as the Administrative Measures for Human Assisted Reproductive Technology, the Regulations for Human Assisted Reproductive Technology and so forth, have been issued since 2001. Further improvement of key performance indicators (KPIs) correlated with ART quality and safety control is of the top priority and also challenging. In addition, the ART surveillance data in China is still aggregated data, which does not include important indicators such as age stratification, infertile factors or indications and delivery gestational age, maternal and infant outcomes, with some limitations for surveillance. Continuous improvement of data quality, and initiation of cycle-based data collection and security measures of case information are also challenging for the next step.

Sosialisasi Legalitas Usaha Untuk Masa Depan UMKM Yang Berkelanjutan

This research explores the vital role of business legality in supporting the growth and sustainability of Micro, Small, and Medium Enterprises (MSMEs) in Indonesia. Through a combination of interview and direct observation approaches, we investigate the challenges faced by MSMEs in obtaining appropriate business legality and its impact on market access and financing. The findings indicate that a lack of understanding of the importance of business legality, complex licensing processes, and the need for specific requirements are major obstacles for MSMEs, especially those operating at the micro and small levels. Furthermore, we conclude that complete and legally valid business legality forms a solid foundation for the growth of MSMEs, enabling broader access to formal markets and financial resources. The approach of mentoring in obtaining the Business Identification Number (NIB) emerges as an effective solution in assisting MSMEs in overcoming challenges related to business legality. Comprehensive mentoring programs, ranging from education about the registration process to practical assistance in gathering required documents, provide much-needed support for MSMEs like Bu Siti in navigating complex registration processes. Evaluation and feedback, as well as effective information dissemination, also prove crucial in increasing MSMEs' awareness and understanding of licensing procedures and the benefits of having complete business legality. Thus, collaborative efforts from various parties can help create a more conducive environment for the growth of MSMEs in Indonesia.

NOMOR INDUK BERUSAHA SEBAGAI LEGALITAS BAGI PELAKU UMKM DESA TAWAR KABUPATEN MOJOKERTO

Micro, Small, and Medium Enterprises (MSMEs) play a crucial role in supporting regional economic growth, particularly in the aftermath of the COVID-19 pandemic. One concrete manifestation of governmental assistance is the implementation of Government Regulation Number 24 of 2018, which introduces the Online Single Submission (OSS) platform to streamline the licensing process, specifically in obtaining the Business Identification Number. Through OSS, the licensing procedure becomes more efficient, rapid, and transparent. The adoption of OSS aims not only to provide convenience for business entities but also to bolster investment in the MSME sector. It is recommended to enhance the comprehension of business stakeholders through additional training and awareness initiatives to fortify business legitimacy, foster MSME expansion, and generate positive effects on local economic development. The methods utilized for activity execution encompass lectures, discussions, and practical sessions, targeting micro, small, and medium-sized enterprises situated in Tawar Village, Mojokerto Regency. This endeavor has been effectively carried out, resulting in a notable increase in the successful registration of Business Identification Numbers (NIBs).

Comparative Legal Analysis of IT Legislation of Russia and Sweden

INTRODUCTION. This article provides a compre­hensive analysis of the regulatory frameworks govern­ing the information technology (IT) sector in both Russia and Sweden and encompasses a comparative assessment of key legal instruments, concepts, and regulatory approaches, including the responsibility for cybercrimes, licensing procedures, standardization practices, and the safety of critical informational in­frastructure. Additionally, this article examines the roles and functions of major governing authorities in both countries.MATERIALS AND METHODS. The article is based on relevant legal acts of Russia and Sweden. While there are certain specific laws focused entirely on the informational technologies, some provisions can be found in other types of legal documents (for example criminal codes or governmental regulations). Employ­ing a comparative approach, the study delineates the scope and authority of state institutions involved in the IT sphere.RESEARCH RESULTS. Both Russian and Sweden exhibit similarities when it comes to definition of es­sential concepts such as critical infrastructure, reflect shared concerns regarding for example security issues. Main laws in the area of information technology con­tain a spectrum of key terms, including but not limited to information and communication network / elec­tronic communication network, information system operator, and information protection / network and information system security. Although the list of key definitions may appear quite similar, the Swedish leg­islation tends to offer broader definitions with the in­tention of encompassing larger domains within IT technologies, while the Russian legislators focus on more specific terms. However, while Sweden aligns closely with European Union (EU) regulatory frame­work, Russia adopts a more expansive approach, ad­dressing emerging technological challenges such as AI. In conclusion, achieving effective IT regulation neces­sitates finding a balance between international con­sistency and national adaptability to ensure strong cybersecurity, foster innovation, and maintain regula­tory flexibility in a dynamic digital environment.DISCUSSION AND CONCLUSIONS. Sweden’s re­liance on implementing EU regulations has its benefits such as harmonisation, interoperability, adopting the internationally recognised practices, easier market ac­cess, etc. However, this approach may limit the coun­try's ability to meet its specific needs and may mean additional administrative burdens associated with compliance with EU directives. Moreover, changes in EU regulations could lead to a necessity to update do­mestic laws, potentially causing regulatory vacuum or legal collisions, especially in such sphere as the IT sec­tor. Nowadays, when for example the AI and its risks are on the daily agenda one can not look away and wait for the international community to agree on the applicable regulation.