1. Reports only via e-Sanepid

Every dietary supplement introduced to the market for the first time must be reported to the Chief Sanitary Inspector (GIS). Until now, various forms were acceptable – paper or electronic, with a handwritten or electronic signature. After the amendment comes into effect, the only acceptable method will be the e-Sanepid platform.

What does this mean in practice?

• It is necessary for each person submitting notifications to have a qualified electronic signature or a trusted profile.
• All communication with sanitary inspection bodies – letters, decisions, and confirmations – will be handled through the platform account. The moment of notification submission will be clearly confirmed with an official receipt, eliminating disputes over the deadline.
• Companies that have previously used paper forms or traditional correspondence must immediately switch to the new channel and ensure appropriate employee training.

The change also concerns the timing of the notification obligation: the previous option to notify the Chief Sanitary Inspectorate (GIS) at the stage of intended product introduction is no longer available. The obligation now arises at the time of actual introduction to the market.

2. Strict deadlines and automatic presumption of irregularities

The amendment introduces a completely new mechanism for conducting investigations. This change has the greatest potential to surprise companies without effective internal compliance procedures.

How does the new mechanism work?

If the Chief Sanitary Inspectorate initiates an investigation and requests the entity to submit a scientific opinion, the company has exactly 14 days to submit an application to an accredited scientific unit – at the same time forwarding a copy of it to the Chief Sanitary Inspectorate.

The mechanism for presuming irregularities is a significant innovation. Previously, a company’s inaction during the proceedings did not automatically result in any legal consequences – the proceedings could drag on for years. Following the amendment, any failure to meet the 14-day deadline will lead to direct negative consequences, regardless of whether the product is safe.

3. Advertising without reporting? A fine of nearly one million zlotys

This change directly impacts brands engaging in active digital marketing. Previously, advertising or presenting a dietary supplement without prior notification to the Chief Sanitary Inspectorate (GIS) was punishable by a fine (a misdemeanor). Following the amendment, this becomes grounds for imposing an administrative fine – with new, significantly higher penalties.

What exactly is prohibited?

The amendment penalizes not only the sale of a supplement without reporting it to the Chief Sanitary Inspectorate (GIS), but also the mere advertising or presentation of it if the notification has not been effectively submitted. In other words:

• Sponsored post on Instagram or Facebook promoting a new supplement before notification = grounds for an administrative penalty.
• Product page in the online store visible to the public before successful reporting to GIS = risk of infringement.
• Promotional materials sent to wholesalers or distributors before GIS is notified = potential infringement.
• Influencer marketing initiated before the date of effective notification = liability on the part of the entity commissioning the campaign.

Prohibition on suggesting medicinal properties – wider scope

The amendment expands liability for violations of advertising requirements from labeling to the entire marketing message. Previously, sanctions primarily covered incorrect packaging labeling. Following the amendment, a company is responsible for every communication channel – online advertising, point-of-sale materials, newsletters, or YouTube videos – if the message suggests that a varied diet does not provide sufficient nutrients, or if a supplement is presented as a medicinal product.

4. Public register – the company’s reputation under public scrutiny

The Chief Sanitary Inspectorate (GIS) has maintained a register of dietary supplements before, but the amendment will significantly expand its scope and availability. The data will be published on the e-Sanepid platform and will include:

• the name of the product and its qualitative composition (without quantitative data – the recipe remains protected),
• product qualification proposed by the entity,
• information about the initiation or ongoing investigation,
• data on the detection of a prohibited ingredient.

5. Fines – increase by over 330%

The maximum administrative fine for violating food safety regulations is increasing from 30 to 100 times the average monthly salary. At the current salary level, this means:

The new penalties are imposed administratively (not as fiscal or misdemeanor offenses), which means faster proceedings and no need to prove intentional guilt. A mere finding of a violation is sufficient. The increased level of sanctions has a real deterrent effect, especially for companies with turnover in the tens of millions of zlotys.

The biggest risks – a practical overview

Artykuł CLIENT ALERT Dietary supplements market in Poland Amendments to food safety regulations | May 2026 pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

We are delighted to share an important milestone in the continued development of KG Legal’s Data, AI & Cybersecurity Desk.

It has been a great honour to serve as the exclusive expert contributors for Poland to the OneTrust DataGuidance Privacy Overview – Poland, one of the world’s leading professional legal compliance resources relied upon by in-house counsel, privacy professionals, compliance officers, multinational organisations and technology companies operating across multiple jurisdictions.

Preparing this contribution was a long-term project that required several months of intensive legal analysis, research and editorial work. Our objective was not simply to describe the application of the GDPR in Poland. Instead, we sought to create a practical and comprehensive guide reflecting the significant transformation of the Polish regulatory landscape that has taken place in recent years as a result of new European legislation and its implementation into Polish law.

The publication therefore extends far beyond a traditional overview of Polish data protection law. It examines the interaction between privacy, digital regulation, cybersecurity and artificial intelligence, providing readers with practical guidance on the most important legal developments affecting organisations operating in Poland.

Our contribution discusses, among other things:

• the practical application of the GDPR within the Polish legal system;
• the powers and regulatory practice of the Polish supervisory authority for personal data protection;
• employee monitoring and workplace privacy;
• cookies, consent mechanisms and online tracking technologies;
• electronic communications and direct marketing requirements;
• international data transfers;
• personal data breaches and notification obligations;
• practical compliance with Polish privacy legislation;
• cybersecurity-related regulatory developments;
• the growing interaction between data protection and artificial intelligence governance.

A particularly important aspect of this work was addressing the rapidly evolving legislative environment. During the last few years, Poland has experienced substantial regulatory changes resulting from the implementation of numerous European legal instruments and the entry into force of directly applicable EU regulations that significantly affect organisations processing personal data.

Accordingly, the publication takes into account the practical implications of the evolving European digital regulatory framework, including the interaction between the GDPR and newer legal instruments governing digital services, artificial intelligence, cybersecurity and data governance. The analysis also reflects the impact of the AI regulatory framework, developments concerning data governance and electronic communications, as well as the increasingly interconnected compliance obligations facing businesses operating in today’s digital economy.

Rather than presenting legislation in isolation, the publication adopts a practical, compliance-oriented perspective. It combines:

• the GDPR and Polish implementing legislation;
• guidance issued by the European Data Protection Board (EDPB);
• the jurisprudence of the Court of Justice of the European Union;
• decisions and regulatory guidance published by the Polish Personal Data Protection Office (UODO);
• recent Polish legislative developments and market practice.

Our ambition was to create a resource that would assist both international and domestic organisations in navigating one of the fastest-changing areas of European regulation, where privacy law increasingly intersects with cybersecurity, AI governance, digital platforms, online communications and emerging technologies.

The contribution was prepared by Małgorzata Kiełtyka and Jakub Gładkowski, whose combined experience covers complex cross-border advisory work in data protection, artificial intelligence, life sciences, healthcare, technology law, cybersecurity, intellectual property and regulatory compliance.

https://www.dataguidance.com/experts-directory/Jakub_G%C5%82adkowski

https://www.dataguidance.com/experts-directory/Malgorzata_Kieltyka

For many years, Małgorzata Kiełtyka has advised international companies on GDPR compliance, healthcare regulation, AI governance, technology transactions and cross-border regulatory matters. Her practice combines strategic legal advice with practical implementation of compliance frameworks for multinational businesses operating in highly regulated sectors.

Jakub Gładkowski focuses on data protection, digital regulation, cybersecurity, intellectual property, IT law and emerging technologies. His practice includes advising innovative businesses on regulatory compliance, digital transformation projects and the implementation of European technology legislation affecting both public and private sector organisations.

Being entrusted with preparing Poland’s national contribution to OneTrust DataGuidance represents an important recognition of our team’s expertise and international standing. We are particularly proud that this publication reflects not only our experience in privacy law, but also our broader interdisciplinary approach, integrating data protection with AI regulation, cybersecurity, digital compliance and technology law.

We sincerely thank the editorial team at OneTrust DataGuidance for their confidence in our expertise and for the opportunity to contribute to a publication that supports legal and compliance professionals around the world.

For KG Legal, this publication marks another significant milestone in the continued growth of our Data, AI & Cybersecurity Desk and reinforces our commitment to delivering practical, business-oriented legal advice at the intersection of privacy, technology and innovation.

Artykuł A Major Milestone for KG Legal’s Data, AI & Cybersecurity Practice: Exclusive Poland Contribution to OneTrust DataGuidance pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

The Polish dietary supplements market is facing the most significant regulatory overhaul in years. The draft amendment to the Act on Food and Nutrition Safety and the Act on the State Sanitary Inspectorate introduces a series of far-reaching changes that will substantially alter the way supplements are notified, monitored, advertised, and supervised in Poland. While the reform does not formally introduce a pre-market authorization system, it undeniably strengthens the position of regulatory authorities and increases the compliance burden imposed on businesses operating in the sector.

The amendment, expected to enter into force six months after publication, reflects both domestic concerns regarding the rapid expansion of the supplements market and the broader European trend toward stricter food safety oversight. For manufacturers, importers, distributors, and marketing agencies, the proposed changes may require a complete reassessment of internal procedures, legal risk management, and commercial strategy.

The reform arrives at a time when the Polish dietary supplements market continues to expand at an exceptional pace. Poland has become one of the largest supplement consumers in the European Union, both in terms of total market value and per capita spending. According to market estimates, the sector exceeded PLN 7 billion in value in 2024 and is expected to continue growing steadily over the coming years. The scale of the market alone has become a challenge for regulators. Between 2017 and 2020, more than 62,000 supplement notifications were submitted to the Chief Sanitary Inspectorate (GIS), while the number of products listed in official registers exceeded 29,000.

At the same time, authorities increasingly pointed to systemic weaknesses in the existing framework. Under the current rules, a business may place a dietary supplement on the market immediately after submitting a notification to GIS, even if doubts exist regarding the product’s composition or classification. The authorities may initiate explanatory proceedings, but the product can still remain commercially available during the investigation. In practice, this system has often been criticized for providing insufficient preventive control and allowing potentially problematic products to circulate before any meaningful assessment takes place.

Another major concern involved the widespread use of aggressive advertising strategies. For years, the dietary supplements industry has been accused of blurring the line between supplements and medicinal products. Many advertisements indirectly suggested therapeutic effects or implied that supplements could substitute proper medical treatment or balanced nutrition. Regulators and pharmaceutical companies repeatedly argued that existing penalties were too low to deter large market participants from engaging in questionable promotional practices.

The lack of a centralized digital supervision system also contributed to inefficiencies. The notification process relied partly on outdated administrative mechanisms, resulting in difficulties with document verification, inconsistent communication, and lengthy proceedings. The new amendment seeks to address these concerns through digitalization, stricter procedural obligations, and substantially higher financial sanctions.

One of the most visible changes introduced by the reform is the mandatory use of the e-Sanepid platform for all supplement notifications. Until now, notifications could be submitted either electronically or in paper form, and businesses had some flexibility regarding the form and timing of submission. Under the new rules, however, the process becomes fully digitized. Notifications will only be accepted through the e-Sanepid system and will require either a qualified electronic signature or a trusted electronic profile.

This change may appear largely technical at first glance, but in reality it significantly increases the formalization of the entire notification process. For large companies with developed compliance departments, adapting to electronic communication systems is unlikely to create serious difficulties. Smaller businesses, however, may face operational and financial challenges connected with digital authentication tools, procedural monitoring, and document management requirements.

The amendment also changes the moment at which the notification obligation arises. Previously, the law referred both to products already introduced to the market and those merely intended for future introduction. The new wording removes the reference to “intended introduction,” meaning that the obligation will arise only once the product is actually being placed on the market. Although this clarification simplifies the legal interpretation of the obligation, it also narrows the flexibility businesses previously enjoyed when planning product launches.

Perhaps the most consequential aspect of the reform concerns explanatory proceedings and scientific opinions. Under the current framework, businesses could effectively delay proceedings indefinitely by postponing the submission of required scientific documentation. While the law imposed certain deadlines on the authorities themselves, it did not establish sufficiently strict obligations for the notifying entity. This created situations where proceedings remained unresolved for years, significantly limiting the effectiveness of supervision.

The amendment introduces a much stricter procedural regime. Once GIS requests a scientific opinion regarding a product’s classification or compliance, the business will have only 14 days to submit an application to a scientific institution or to the President of the Office for Registration of Medicinal Products. Furthermore, the scientific opinion itself must generally be issued within six months, with an absolute maximum period of twelve months in exceptional cases.

The most significant innovation is the introduction of a legal presumption against the entrepreneur. If the entity fails to submit the application for an opinion within the required 14-day period, the law will automatically presume that the proposed classification of the product is incorrect and that the product does not meet the requirements applicable to its category. In practical terms, procedural inactivity itself may lead to negative legal consequences.

This fundamentally changes the balance between businesses and regulatory authorities. Previously, delaying the process often worked in favor of companies by allowing products to remain on the market while proceedings continued. Under the new rules, inaction may immediately weaken the entrepreneur’s legal position. Businesses will therefore need to implement much stricter internal monitoring systems to ensure compliance with procedural deadlines.

The amendment additionally prohibits businesses from circumventing the procedure by repeatedly submitting notifications for identical products. Once proceedings are initiated, companies will no longer be able to submit another notification concerning a product with the same qualitative and quantitative composition. Similarly, withdrawing a notification will not allow the entrepreneur to restart the process with the same formula at a later stage. These restrictions are intended to eliminate procedural abuse and prevent companies from avoiding regulatory scrutiny through repeated filings.

Another major reform concerns transparency and the expansion of the public product register maintained within the SEPIS system. The current register already contains certain information regarding notified products, but the scope of publicly available data remains relatively limited. The new system significantly broadens the amount of information accessible to consumers and competitors alike.

Under the amendment, the register will include the product name, form of the product, qualitative composition, information regarding active substances, details concerning explanatory proceedings, and information about prohibited ingredients. Although quantitative composition data and certain identifying information regarding the reporting entity will remain confidential, the reform nevertheless represents a substantial increase in market transparency.

From the consumer protection perspective, this may be viewed as a positive development. Consumers will gain easier access to information about supplement composition and regulatory status, potentially allowing for more informed purchasing decisions. However, from the business perspective, the new transparency rules create considerable reputational risks. Information regarding ongoing explanatory proceedings may become publicly visible long before any final administrative decision is issued. As a result, companies may face reputational damage even in situations where no violation is ultimately confirmed.

The reform also updates the broader inspection framework to align Polish law with Regulation (EU) 2017/625 on official controls. Although the regulation has already been directly applicable across the European Union since 2019, several references in Polish legislation still pointed to repealed EU acts. The amendment therefore modernizes the legal terminology and adapts national provisions to the currently binding European framework.

Importantly, however, the changes do not significantly expand the substantive powers of sanitary authorities. The amendment primarily introduces terminological adjustments, extending references from “official food controls” to “official controls and other official activities.” Sanitary authorities will continue to possess extensive powers during inspections, including access to facilities, examination of production processes and documentation, and collection of samples for laboratory testing.

The reform does, however, expand the situations in which businesses must bear the costs of inspections and administrative activities. In addition to existing obligations related to violations, follow-up inspections, and border sanitary controls, businesses will now also be required to cover costs associated with official activities performed at their own request, such as the issuance of certain documents. While this change may appear relatively modest compared to other parts of the reform, it nevertheless contributes to the overall increase in operational costs for market participants.

One of the most controversial elements of the amendment concerns advertising and marketing practices. The reform significantly broadens the scope of administrative liability related to the promotion and presentation of dietary supplements. Previously, penalties focused primarily on incorrect product labeling. Under the new rules, liability will explicitly extend to advertising, online promotion, social media activities, and the overall presentation of products.

Most importantly, the amendment introduces severe sanctions for advertising or presenting a supplement before notifying GIS. This is likely to have a major impact on digital marketing strategies commonly used in the supplements industry. Influencer campaigns, online pre-launch promotions, teaser advertisements, and social media product announcements may all potentially fall within the scope of the new sanctions if conducted before formal notification.

The amendment also reinforces existing prohibitions against suggesting that a balanced diet cannot provide sufficient nutrients or implying medicinal properties of supplements. Although these prohibitions already existed under current law, the reform significantly strengthens enforcement mechanisms by attaching much higher financial penalties to violations.

Indeed, the increase in administrative penalties represents one of the most dramatic aspects of the reform. Under the current framework, the maximum administrative fine generally amounts to thirty times the average monthly salary. The amendment raises this threshold to one hundred times the average salary, increasing potential penalties by more than 330 percent.

Based on current economic indicators, maximum fines could exceed PLN 800,000. Such amounts are clearly intended to function as genuinely deterrent sanctions rather than symbolic administrative measures. For large corporations with extensive marketing operations, these penalties may significantly alter risk calculations related to aggressive advertising or borderline compliance practices.

For businesses operating in the supplements sector, the cumulative impact of these changes may be substantial. Compliance costs are likely to increase considerably. Companies may need to invest in legal advisory services, digital infrastructure, scientific assessments, employee training, and enhanced compliance monitoring systems. Marketing departments in particular will face increased scrutiny and will need to carefully verify advertising content before publication.

The reform may also contribute to market consolidation. Large, well-established companies are generally better positioned to absorb increased compliance costs and adapt to stricter regulatory requirements. Smaller businesses, startups, and niche supplement brands may struggle with the financial and administrative burden created by the new framework. As a result, the amendment could unintentionally reduce market diversity and strengthen the competitive position of major industry players.

From the perspective of public authorities, the reform aims to improve the efficiency and credibility of food safety supervision. Digitalization through e-Sanepid and SEPIS is expected to accelerate administrative processes, improve data analysis capabilities, and strengthen market oversight. The introduction of strict procedural deadlines should also reduce the risk of excessively lengthy proceedings and administrative disputes.

At the same time, the implementation of these systems will require significant investments in technological infrastructure and administrative capacity. The effectiveness of the reform will therefore depend not only on the wording of the legislation itself, but also on the practical ability of GIS and related institutions to manage the new digital environment efficiently.

Ultimately, the amendment does not formally transform dietary supplements into products requiring prior authorization before market entry. Businesses will still be able to introduce supplements through a notification-based system rather than a licensing procedure. Nevertheless, the practical reality of operating in the sector is likely to change considerably.

The reform substantially increases the procedural obligations imposed on businesses, strengthens enforcement tools available to authorities, raises financial exposure connected with non-compliance, and introduces far greater transparency into the market. While these changes may improve consumer protection and market oversight, they also create new operational and reputational risks for entrepreneurs.

For companies active in the supplements industry, the coming months may therefore become a critical period of preparation. Businesses that fail to adapt quickly to the new regulatory environment may face not only financial penalties, but also significant disruptions to their commercial operations and marketing strategies.

Artykuł Dietary Supplements Under Tightened Scrutiny: How the 2026 Reform Could Reshape the Polish Market pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

On June 19, 2026, representatives of our law firm will participate in the Data Science Summit AI Edition 2026, which will be held at the Palace of Culture and Science in Warsaw. For many years, the event has been one of the most important technology conferences in Central and Eastern Europe, bringing together specialists responsible for the development and implementation of the most advanced solutions based on artificial intelligence, machine learning, and data analysis. It provides a meeting place for the business, technology, scientific, and administrative communities—a space where implementation practice meets regulatory and strategic reflection.

Link to the event: https://ml.dssconf.pl/#agenda

This year’s edition focuses on the most important directions of development of modern artificial intelligence, including, among others, generative AI ( Generative AI), large language models (LLM), GPT systems, AI agents, Agent-to-Agent (A2A) architectures, Context Model Protocol (MCP), reinforcement learning, computer vision, predictive analytics, MLOps, LLMOps, AI governance and broadly understood data-driven business transformation.

The conference is aimed at data scientists, AI experts, data engineers, IT system architects, programmers, cybersecurity specialists, digital transformation leaders, product development managers, public administration representatives, and executives of enterprises implementing AI-based solutions. Speakers will include representatives of global technology companies, international corporations, financial institutions, telecommunications operators, energy companies, research and development organizations, academia, and technology startups – including AI directors, chief system architects, digital transformation leaders, scientists, AI engineers, MLOps experts, cybersecurity specialists, and managers responsible for implementing technological innovations.

The event is distinguished by its practical nature. The program focuses not only on presenting technological innovations, but primarily on showcasing real-world implementations already in place in businesses, public administration, the financial and energy sectors, e-commerce, telecommunications, healthcare, and industry.

Enterprise AI – From Experiment to Infrastructure

One of the most important themes of the conference is the practical use of artificial intelligence in production environments. It is increasingly clear that AI has ceased to be an experimental technology and has become a component of real-world business infrastructure. In this context, we are analyzing ways to counteract the phenomenon of so-called information bubbles and build more sustainable recommendation systems used by the largest media platforms. Methods are emerging to increase the diversity of presented content, reduce algorithmic bias, and design systems that responsibly influence user behavior.

A key issue is the collaboration between classic machine learning and generative AI. Combining both approaches allows for the development of scalable, cost-effective solutions, ready for use by large organizations. A significant portion of the discussion also focuses on countering financial fraud – methods for detecting fraud and building competitive advantage through structured AI system development processes. Developer experience and modern work environments for AI teams are also gaining importance, including ways to accelerate the creation and maintenance of AI-based applications.

The technological landscape is strongly influenced by the prototyping of AI agents using modern programming environments and platforms supporting the creation of autonomous systems. Simultaneously, there are emerging themes regarding the use of AI in the legal sector – methods for assessing the reasoning ability of language models, methods for tracing legal sources, and techniques for increasing the reliability of AI-generated responses. From a security perspective, mechanisms for securing autonomous systems against attacks, unauthorized access, and attempts to manipulate their behavior are particularly important.

Equally important is the optimization of language models – techniques for quantization, distillation, and model size reduction while maintaining high efficiency. In the financial sector, solutions are emerging that include automated document processing, data extraction, and the development of intelligent analytical platforms. As an illustration of the creative potential of AI, the mechanisms behind music generation by artificial intelligence and the application of deep learning in creative processes are also discussed.

Generative AI – Multimodality, Agents, and Public Administration

Generative AI is one of the fastest-growing areas of contemporary technology. In production practice, it is used to automatically describe works of art, create alternative descriptions that increase the accessibility of digital documents for people with disabilities, and develop strategies for replacing very large and expensive language models with smaller, specialized solutions that can be effectively used in enterprises. The evolution of architectures leads from simple prompts, through RAG mechanisms, to multi-stage pipelines integrating multiple data sources and advanced LLM architectures.

Multimodality plays a significant role – solutions that can simultaneously analyze text, images, sound, and spatial information – opening the door to building more versatile AI systems. In enterprise environments where standard communication protocols aren’t feasible, building agents that exclusively utilize approved APIs, internal tools, and development platforms becomes crucial, while adhering to security and governance principles.

A crucial direction is the use of artificial intelligence in public administration, including the process of transforming an AI project into a product accessible to millions of citizens. Solutions that generate sound, speech, and music using modern diffusion models and transformers are also gaining importance, as are automatic analysis of PDF documents and the extraction of structured data from multi-page administrative materials. Hybrid pipelines combining generative AI, signal processing, and embedded systems for use in resource-constrained devices are also emerging. A separate, increasingly important issue is assessing the quality of RAG chatbots, testing them before deployment, and building reliable conversational systems.

Machine learning in practice – recommendations, energy, finance

Classic machine learning remains relevant – on the contrary, it’s finding applications in major industrial and financial implementations. Modern recommendation systems are emerging, based on data representation vectors and embedding architectures, where balancing recommendation effectiveness with the ability for users to discover new content is paramount. Digital twins are being used to optimize energy assets and manage industrial infrastructure. In the financial sector, teams of collaborative models are emerging to support decision-making processes.

The challenges associated with AI agents operating in social media are increasingly being discussed – issues such as user privacy, data security, and customer interaction design. In the banking sector, there’s a clear trend toward building millions of personalized models operating in parallel, which requires advanced training optimization, system scaling, and efficient processing of massive data sets.

Deployments, MLOps, and Security – The AI Systems Lifecycle

One of the most practical areas of the event is implementing, maintaining, and scaling AI systems in production environments. Simply developing a model is no longer the biggest challenge; ensuring its stable, secure, and effective operation in real-world business environments is crucial.

The security of generative AI is becoming one of the most pressing issues. Practical methods are emerging to protect models from prompts, injection, jailbreaking, and attempts to bypass control mechanisms. Referring to OWASP guidelines and modern solutions enabling the implementation of AI systems in accordance with the security- by-design principle is becoming standard.

From a legal perspective, issues related to designing global data platforms operating simultaneously in multiple jurisdictions are particularly important. These challenges include data sovereignty, local regulations, and the need to reconcile legal requirements across different jurisdictions.

A key theme is the full lifecycle of machine learning models – the processes of building, deploying, monitoring, updating, and retiring AI models, as well as how to manage their performance at scale. System performance optimization plays a significant role – techniques for reducing latency, shortening inference times, and adapting models to various hardware environments. Case studies from the pharmaceutical sector also appear, demonstrating how to manage chatbots’ deviance from their original purpose and how to minimize the risk of generating undesirable responses. Simultaneously, computer model optimization techniques are being developed, allowing to increase their efficiency many times while maintaining high quality of prediction.

Monitoring LLM systems and AI agents before end-user errors occur is becoming particularly important. Systems for model tracking, automated evaluation, anomaly detection, cost management, and continuous response quality improvement are emerging. Solutions are emerging that enable the management of thousands of AI agents and their evaluation at scale. This is complemented by approaches based on GitMLOps, DevSecOps, and modern observability solutions for systems based on large language models.

AI Agents – Autonomous Decision-Making Systems

One of the most important areas of the conference is AI agents. Modern artificial intelligence is increasingly moving beyond the role of a mere tool for human support and instead becoming an autonomous system capable of executing complex business processes. Methods are emerging for assessing the effectiveness of large-scale multi-agent systems – methods for automated testing, reliability testing, tracing error sources, and building systems that guarantee repeatable results. Significant attention is being paid to monitoring agents in real time, identifying errors, measuring response quality, and continuously improving decision-making processes.

Issues related to the security of AI agents are becoming increasingly important, including attack scenarios that confuse autonomous systems and methods for securing them against manipulation. Practical applications of agents utilizing financial, registry, and business data are emerging, supporting analytical, scoring, and decision-making processes. AI agents are also finding applications in telecommunications and in the construction of systems that independently conduct research and analysis.

Agents’ long-term memory plays a significant role – solutions utilizing knowledge graphs and mechanisms that enable agents to independently organize and expand their accumulated knowledge. Real-time voice agents are highly practical – systems capable of conducting telephone conversations with users, analyzing speech, and generating responses that approximate natural communication. Solutions are also emerging that enable automatic detection of problems arising during the operation of production agents and the generation of evaluation processes without human intervention. Applications also include systems supporting energy management, intelligent buildings, and Internet of Things devices. A separate, important area is the evaluation of Text -to-SQL systems, which enable the automatic conversion of natural language into database queries.

Development and tuning of large language models

A significant portion of the conference was devoted to the creation, training, and refinement of large-scale language models. The most common errors made when building AI models are increasingly understood, as is the significant impact that the proper selection of training data has on their quality. Specialized models for the banking sector are being developed, along with methods for adapting them to specific business applications.

A significant area of research is Polish multimodal models capable of simultaneously understanding text and images, including methods for building them with limited data resources. Techniques for simplifying official and administrative language using language models are also emerging, with a particular emphasis on increasing the accessibility of public transportation. Mechanisms for building trust in artificial intelligence by providing users with justifications for generated responses are gaining increasing importance. Embedding models, used to identify duplicate data, ambiguous names, and unstructured addresses, are becoming increasingly important in everyday business practice.

Business Transformation – Strategy, Data, and Organization

From a strategic perspective, artificial intelligence is becoming one of the most important elements in building a competitive advantage for enterprises. Practical experience is emerging with implementing generative AI in international organizations and managing technological transformation processes. Methods for identifying the most promising AI initiatives from among hundreds of potential projects are becoming increasingly important.

Data quality plays a significant role – proper data preparation is now a prerequisite for the effective implementation of artificial intelligence. Critical analysis of technological trends is also emerging, allowing us to separate the true capabilities of AI from marketing hype. The importance of data architecture and IT systems for the success of transformation projects is becoming increasingly clear. The debate on the future of management in the era of agent-based AI and the changes AI will bring to corporate organizational structures is particularly prominent. Examples of building scalable customer service agents operating simultaneously in multiple countries are also emerging, as are the experiences of large organizations implementing AI, developing data products, supporting business expansion, and transforming the banking sector.

AI in Software Development – Regulation, Security, and Intellectual Property

Artificial intelligence is fundamentally changing the way technology teams work. Building local systems to support programming in compliance with European regulations, including the AI Act and NIS2, is becoming increasingly important. Both the potential and limitations of modern programming assistants are emerging, including the reasons for the failure of AI agents working with enterprise data and ways to build more predictable systems.

Cybersecurity, threat modeling, and vulnerability management in AI-based systems are all important topics, as are the practical aspects of building agent platforms capable of operating in production environments. From a legal perspective, issues related to intellectual property protection, commercialization of AI-based solutions, copyright management, and building secure technological product development processes are particularly important.

Computer Vision – intelligent image analysis

Modern image analysis goes far beyond classical object recognition. New approaches are emerging to using visual models in unusual applications, including Visual RAG systems that enable automated processing of data contained in spreadsheets and corporate documents. The technological trade-offs involved in designing high-performance pipelines are increasingly understood. computer vision. Computer vision is also used in climate forecasting and analysis of environmental phenomena, as well as in automatic data extraction from Polish administrative and business documents.

Debates about the future of artificial intelligence

An integral part of the event are expert roundtable discussions. The role of software agents is discussed – whether they will become merely a tool to support specialists or will they take over some of their responsibilities. The use of AI agents as digital equivalents of junior engineers supporting data science teams is also discussed. Experts engage in debates on the labeling of AI-generated content and the transparency of AI systems.

A separate discussion is devoted to Europe’s technological sovereignty and the possibility of building an independent artificial intelligence ecosystem. The discussion concludes with a discussion on the competencies of the future and the skills that will become crucial for organizations to function in an AI-based economy.

The Data Science Summit AI Edition 2026 demonstrates that artificial intelligence is no longer just a technology of the future. It has become one of the most important tools shaping modern businesses, public administration, and the financial, energy, industrial, and technology sectors. The scale and scope of the topics covered confirm that AI development today requires not only advanced technological competencies but also appropriate risk management, security, regulatory compliance, and a responsible approach to implementing new technologies – making law firms’ participation in such events a natural part of tracking the directions in which new technologies law is heading.

#DataScienceSummit #AIEdition2026 #ArtificialIntelligence #AI #MachineLearning #GenerativeAI #LLM #GPT #AIAgents #AgenticAI #AgentToAgent #ModelContextProtocol #MCP #DeepLearning #ReinforcementLearning #ComputerVision #PredictiveAnalytics #MLOps #LLMOps #AIGovernance #ResponsibleAI #AIEthics #AISecurity #PromptInjection #Jailbreaking #SecurityByDesign #OWASP #DevSecOps #GitMLOps #CyberSecurity #DataSovereignty #AIAct #NIS2 #EURegulations #TechSovereignty #DigitalTransformation #BusinessTransformation #DataDriven #DataQuality #DataEngineering #DataScience #CloudComputing #RAG #VisualRAG #Multimodal #Multimodality #Embeddings #VectorSearch #Quantization #ModelDistillation #FineTuning #TextToSQL #KnowledgeGraphs #VoiceAgents #ConversationalAI #Chatbots #DigitalTwins #IoT #SmartBuildings #EnergyManagement #FinTech #BankingAI #LegalTech #LawFirm #IntellectualProperty #Copyright #PublicAdministration #GovTech #HealthcareAI #PharmaAI #Telecommunications #SoftwareDevelopment #AIAssistants #CodingAgents #Innovation #TechConference #Warsaw #CEE #KGLegal #KieltykaGladkowski

Artykuł Representatives of our law firm KG LEGAL KIEŁTYKA GŁADKOWSKI will take part in the Data Science Summit AI Edition 2026 – one of the largest events dedicated to artificial intelligence in Central and Eastern Europe pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

The purpose of an inspection of the pharmacovigilance system for medicinal products intended for human use (pharmacovigilance inspection) is to verify how the marketing authorization holder for medicinal products is fulfilling its obligations regarding the pharmacovigilance system imposed by Polish and European Union law.

Inspection Basis

Inspections of the pharmacovigilance system are conducted by inspectors from the Department of the Inspection of Medicinal Products and Medical Devices, authorized by the President of the Office. Inspectors are authorized to:

– inspect the marketing authorization holder (MAH) regarding the pharmacovigilance system

– request documentation related to ensuring the functioning of the pharmacovigilance system

– request clarification regarding ensuring the functioning of the pharmacovigilance system

Inspection Process

The inspection of the pharmacovigilance system consists of, among other things:

– verification of the pharmacovigilance system documentation

– interviews with responsible employees, including the QPPV

– checking databases

– insight into the organizational procedures

Inspection

The inspection begins with an opening meeting, which serves to introduce the inspection team and define the purpose and scope of the inspection.

The team will need a room/office where they can interview relevant employees and review documentation.

On the last day of the inspection, during a closing meeting, the inspection team presents their observations and describes any discrepancies in the functioning of the pharmacovigilance system.

What information do inspectors expect from the entity subject to inspection?

Before commencing the inspection, the marketing authorization holder (MAH) is requested to submit a copy of the full description of the Pharmacovigilance Management System (PSMF).

In addition, the MAH should provide inspectors with access to documentation regarding, among other things:

– standard operating procedures, work instructions,

– source documentation for individual case reports (ICSRs),

– periodic safety update reports (PSURs),

– risk management plans for the use of the medicinal product,

Inspection Report

The results of the inspection are presented in an inspection report, which is prepared within 30 days of the inspection completion date. The report is then submitted to the President of the Office for approval. The approved report is forwarded to the MAH.

Types of Inspections:

Routine inspection – conducted after prior notification to the MAH, sent no later than 30 days before the planned inspection.

Targeted inspections are conducted after prior notification to the responsible entity, sent no later than 14 days prior to the planned inspection.

Unannounced inspections are conducted when there is a suspicion that a system malfunction poses a threat to patient life.

It is worth pointing out that apart from Article 24a of Pharmaceutical Law, Chapter 2 of the Act also applies (Article 36b-36z). The Pharmaceutical Law Act regulates pharmacovigilance, in a scope much broader than the inspection itself. The said chapter defines the tasks of the President of Office for the Registration of Medicinal Products, situations in which the Act imposes the obligation to report adverse reactions to the President of the Office, the patient’s right to report adverse reactions, and, among others, the obligations of the marketing authorization holder (MAH) who has obtained a marketing authorization (MAH – Marketing Authorization Holder), which include, for example, maintaining a pharmacovigilance system, appointing a person responsible for safety surveillance and reporting his/her data to the President of the Office, collecting, registering and reporting adverse reactions to medicinal products, presenting, at each request of the President of the Office, within 7 days, a copy of the full description of the safety surveillance system for medicinal products, conducting regular audits, and cooperating with the EMA.

Control under European law:

Significant changes have occurred with the publication of Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025, amending Implementing Regulation (EU) No 520/2012 on activities related to pharmacovigilance. The changes are of various nature, including, among others, reducing the administrative obligations regarding the pharmacovigilance system master file. Implementing Regulation (EU) No 520/2012 specifies, among other things, the content of the pharmacovigilance system master file. To avoid unnecessary administrative burden for applicants and competent authorities, only significant deviations from pharmacovigilance procedures, their impact and their management until the issue is resolved should be documented in the pharmacovigilance system master file, which in particular implies an amendment to Article 4(3).

The same Implementing Regulation introduced new requirements for subcontracting arrangements (added Article 6(3) and (4) and Article 13(1a) of Regulation 520/2012). The marketing authorisation holder may subcontract certain pharmacovigilance system tasks to third parties. However, the main MAH retains full responsibility for the completeness and accuracy of the pharmacovigilance system master file and that the marketing authorisation holder shall draw up a list of existing subcontracting arrangements between himself and third parties. The marketing authorisation holder shall include the following elements in subcontracting agreements: (a) a clear description of the roles and responsibilities of third parties to whom pharmacovigilance activities are subcontracted; (b) a provision obliging third parties to exchange safety data with the marketing authorisation holder and, where appropriate, the method for exchanging safety data; (c) arrangements for the third-party inspection and audit process; (d) a provision obliging third parties to agree to be audited by or on behalf of the marketing authorisation holder and to be inspected by the competent authorities.

Article 13 of the Regulation addresses the auditing requirements imposed by the European legislator on marketing authorization holders. The new wording states in paragraph 1 that: Marketing authorization holders shall conduct risk-based audits of the quality system at regular intervals to ensure its compliance with the requirements set out in Articles 8, 10, 11, and 12 and to determine its effectiveness. Audits, taken individually or in combination, shall cover all pharmacovigilance activities during a designated period and shall verify their compliance with the policies, processes, and procedures defined within the quality system. Audits shall be carried out by persons who are not directly involved in, or responsible for, the matters or procedures being audited. The added paragraph 1a provides that any third party subcontracted to perform all or part of the pharmacovigilance tasks on behalf of marketing authorisation holders or in collaboration with them shall be subject to an audit by or on behalf of the marketing authorisation holders, taking into account the risks associated with subcontracting, and may be subject to an inspection by the competent authorities, even if the subcontracting agreement does not yet include the obligation under Article 6(3).

In addition to audits at regular intervals, audits must be carried out when necessary, including corrective actions and a follow-up audit for non-compliance (Article 13(2)).

The periodic safety update report, in accordance with Article 34 of Commission Implementing Regulation No. 520/2012, contains the results of assessments of the effectiveness of risk minimization activities relevant to the risk-benefit assessment, and from February 2026, will also include information on the implementation of risk minimization measures and the results of the assessment of the effectiveness of the actions taken (Article 34, paragraph 3, new wording).

Another new obligation on the part of MAHs (marketing authorization holders) is to post information on post-authorization safety studies in the EMA electronic register (Article 36, paragraph 5, new wording).

All the changes mentioned above come into force on February 12, 2026; however, the obligation to actively use the EudraVigilance database is different. The amended Article 18, paragraphs 2 and 3 of Regulation 520/2012 obliges MAHs to monitor, but also to use data from the EudraVigiliance database in combination with data from other sources. This obligation has already entered into force, on 12 August 2025, unlike other amendments.

Recital 5 of Commission Implementing Regulation (EU) 2025/1466 explains: “The Eudravigilance database is a system for managing and analysing information on adverse reactions to medicines authorised or undergoing clinical trials. The European Medicines Agency (“the Agency”) and national competent authorities continuously monitor the data in the Eudravigilance database. Marketing authorisation holders also have access to the database to the extent necessary to fulfil their pharmacovigilance obligations. Based on the experience of marketing authorization holders in monitoring data in the Eudravigilance system, the requirements for marketing authorization holders should be clarified, including requirements for approving signals and notifying them to the Agency and national competent authorities. Recital 7 states: “Individual cases of suspected adverse reactions to a medicinal product shall be reported to the Eudravigilance database. Such reports should contain as much information as possible, and to partially standardize them, minimum reporting requirements should be applied to all cases.”

Additionally, Regulation 520/2012 also regulates other issues. Chapter I specifies the pharmacovigilance system master file in terms of structure, content of the system master file and the content of the annex to the system master file. It also introduces rules for system maintenance and specifies the format of documents included in the pharmacovigilance system master file. Chapter II, in turn, specifies the minimum requirements for quality systems for pharmacovigilance activities conducted by marketing authorization holders (the regulations specify the activities covered by the quality system, the requirements that marketing authorization holders must meet in terms of human resources management, e.g., appropriately qualified staff, and the obligation to implement quality procedures and processes to ensure data monitoring, risk minimization, and prevention.

The regulations also specify how data should be recorded and stored, as well as the principles and obligation to conduct audits). The following chapters cover: minimum requirements for data monitoring in the Eudravigilance database, terminology (according to recital 12, the use of terminology, formats, and standards at international level should facilitate the interoperability of systems used for pharmacovigilance activities and avoid duplication of coding of activities concerning the same information. It should also enable easier exchange of information between regulatory authorities at international level), the submission of reports on suspected adverse drug reactions, risk management plans, and periodic safety update reports.

The marketing authorisation holder shall submit the study protocol, the abstract of the final study report and the final study report submitted in accordance with Articles 107n and 107p of Directive 2001/83/EC in English, except for studies conducted in only one Member State and required pursuant to Article 22a of Directive 2001/83/EC. For such studies, the marketing authorisation holder shall submit an English translation of the title and abstract of the study protocol and an English translation of the summary of the final study report.

The marketing authorisation holder shall ensure that all information relating to the trial is recorded and stored in a manner that allows for accurate reporting, assessment and verification of information, and ensures the confidentiality of data relating to trial participants. The marketing authorisation holder shall ensure that the analytical dataset and statistical programmes used to generate the data included in the final trial report are stored electronically and made available for audit and inspection purposes.

When analysing the pharmacovigilance control system, one cannot ignore the so-called soft law, of which the EMA guidelines stand out in particular, such as the Guidelines on Good Pharmacovigilance Practices (GVP) – Module VIII: Post- authorisation safety studies. At this point, the current, applicable version of the GVP Module VIII rev. 3 guidelines has been in force since 2017. The purpose of this document is to ensure a uniform approach in the EU to the design and supervision of PASS (Post- authorization Safety Studies) and to support the relevant authorities (in Poland, this is the President of the office, mentioned earlier) and marketing authorization holders (MAHs). Due to the recent adoption of Implementing Regulation 2025/1466, the adoption of new guidelines, the so-called GVP Module VIII rev. 4, is expected in the near future.

Due to the importance of both Polish and European regulations, and due to the high importance of the guidelines published by the EMA, on May 29, 2025, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued information on studies on the safety and efficacy of the use of a medicinal product conducted after the issuance of authorization – PASS and PAES. It includes, among other things, that: A study on the safety of the use of a medicinal product conducted after the issuance of authorization (Post- authorization safety study (PASS) may be undertaken by the marketing authorisation holder voluntarily or as a result of an obligation imposed by the President of the Office, if there are concerns about the risk associated with the use of a medicinal product or if it is necessary to assess the effectiveness of the measures taken to reduce this risk. If the study will be conducted exclusively in the territory of the Republic of Poland, the marketing authorisation holder shall submit the study protocol to the President of the Office, who shall assess it. Protocols of studies to be conducted in more than one EU Member State should be submitted to the Pharmacovigilance Risk Assessment Committee, which assesses the appropriateness of the proposed protocol. The principles for preparing study protocols and their conduct are included in Commission Implementing Regulation (EU) No 520/2012, Guideline on good pharmacovigilance practices (GVP), Module VIII – Post- authorisation safety studies. It was also indicated that the marketing authorisation holder should register the conducted study in the electronic register maintained by the European Medicines Agency (EMA).

Artykuł Current status of pharmacovigilance in Poland under Polish and EU provisions pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Alternative investment companies are a specific form of investment activity introduced into the Polish legal system within the framework of the provisions on investment funds, and specifically in the context of managing alternative investment funds. These regulations are contained in the Act of 27 May 2004 on investment funds and the Act of 22 July 2005 on the management of alternative investment funds, Journal of Laws 2024.1034. AIICs are therefore a specific form of asset management that creates the possibility of investing in alternative assets, such as real estate, private equity, raw materials or debt, while maintaining high flexibility in terms of investment strategies.

Legal Basis for Alternative Investment Companies

Alternative investment companies are regulated in the Polish legal system by the aforementioned acts on investment funds and on the management of alternative investment funds. In particular, their functioning is associated with the appropriate transformation of the legal form of investment funds, which can operate as capital companies. This means that Alternative Investment Companies are joint-stock companies or limited liability companies that can invest in a wide range of alternative assets.

Pursuant to Article 8a of the Act, alternative investment companies may conduct business in two forms, namely as:

– limited liability companies, joint-stock companies or European companies;

– limited partnerships or limited joint-stock partnerships in which the sole general partner is a limited liability company, joint-stock company or European company.

Key Features of Alternative Investment Companies

Legal form: According to the Investment Funds Act, alternative investment companies may take the form of a joint-stock company or a limited liability company. This means that investors acquire shares or stocks in such companies, which then invest these funds in accordance with a specific investment strategy.

Investment scope: Alternative investment companies, in accordance with the Act on the Management of Alternative Investment Funds, have the ability to invest in a wide range of assets, including:

– Real estate,

– Unlisted companies (private equity),

– Raw materials (e.g. gold, oil),

– Debt instruments (e.g. investments in corporate debt),

– Derivatives and other non-standard assets.

The Investment Funds Act provides great flexibility in the selection of investment instruments, which allows for the implementation of more complex investment strategies.

In accordance with Article 8b of the Act of 27 May 2004 on Investment Funds and the Act of 22 July 2005 on the Management of Alternative Investment Funds (AIF), Journal of Laws 2024, item 1034,

Alternative investment companies are managed by a so-called investment fund manager, which in the case of alternative investment company plays a role equivalent to the management board of an investment fund. In managing this fund, it is important that the people responsible for investment decisions have the appropriate qualifications and experience, and also comply with the requirements related to capital market regulations. Fund managers have an obligation of transparency, responsibility and compliance with legal regulations.

Participant Restrictions: In the case of alternative investment companies, as in other investment funds, there are specific regulations regarding the group of investors. According to the Act on the Management of Alternative Investment Funds, alternative investment companies are intended mainly for professional investors who meet certain criteria, such as the minimum investment value or the status of a professional investor (e.g. financial institutions, wealthy individual investors). Such funds are not aimed at the general public.

According to art. 8c of the Act, an investor in an alternative investment company is an entity that holds participation rights in an alternative investment company and meets the criteria of a professional client. The criteria of a professional client shall not apply if the alternative investment company has obtained the authorization referred to in art. 5 sec. 1 of the Regulation 2015/760 on European long-term investment funds, OJ EU.L.2015.123.98 of 2015.05.19.

The participation rights of an alternative investment company are, respectively, a share in the company and a stock.

In the case of a limited partnership and a limited joint-stock partnership, participation in a company is understood as all the rights and obligations of a partner in the company.

An entity meeting the criteria of a professional client may make a contribution to an alternative investment company in exchange for participation rights in that company.

The subject of a contribution to an alternative investment company operating in the form of a limited partnership may not be an inalienable right or the provision of work or services.

The alternative investment company manager who manages an alternative investment company investing assets in shares of companies admitted to trading on a regulated market shall prepare and publish an engagement policy that describes how the engagement of shareholders of such companies is taken into account by the alternative investment company in its investment strategy. The manager of an alternative investment company shall prepare and publish an annual report on the implementation of the policy. The report shall include in particular:

– general description of voting procedure;

– description of the most important votes;

– description of the method of using the services of a shareholder voting advisor, referred to in Article 4 § 1 item 16 of the Commercial Companies Code, Journal of Laws 2000 No. 94 item 1037.

An alternative investment company may be marketed among:

– professional clients;

– retail clients – in the event that it has obtained the authorisation referred to in Article 5 paragraph 1 of Regulation 2015/760.

The manager of an alternative investment company is obliged to notify the Commission in writing of the intention to introduce an alternative investment company to trading in the territory of the Republic of Poland.

Capital

Initial capital for conducting business activity:

– in respect to externally managed alternative investment company – amounts to at least the equivalent of EUR 125,000 expressed in PLN,

– in respect to internally managed alternative investment company – amounts to at least the equivalent of EUR 300,000 expressed in PLN;

– using the average exchange rate announced by the National Bank of Poland on the last business day preceding the date of submission of the application for a permit to perform business activity by the manager of the alternative investment company.

Initial capital shall be understood as the sum of the share capital in the amount in which it was paid up together with the issue premium, undistributed profits from previous years, as well as the net profit in the process of approval, provided that this profit results from the financial statements audited by a statutory auditor, and the reserve capital, reduced by the uncovered loss from previous years.

Benefits and Challenges of Alternative Investment Companies

Benefits

Flexibility in asset selection – Alternative investment companies have the ability to invest in a wider range of assets than traditional investment funds. This includes the ability to invest in real estate, private equity, venture capital or commodities, which allows for greater diversification of the investment portfolio.

Tax benefits – the Investment Funds Act provides tax preferences for alternative investment companies, which means that profits earned by these companies may be exempt from income tax, provided that the company meets certain conditions regarding the investment structure and activities.

Access to Niche Markets – Alternative investment companies can invest in assets that are hard to access or non-traditional in traditional markets, giving investors the opportunity to participate in profitable but riskier markets.

Challenges

Higher risk – Due to their flexibility in asset selection, alternative investment companies often invest in riskier assets, which is associated with a higher potential return, but also with greater risk. Risk can also result from the illiquidity of some of the assets in which these companies invest.

Lack of liquidity – Many of the investments of alternative investment companies (e.g. real estate and private equity) are illiquid. This means that investors may have difficulty selling their holdings in the short term, which may limit their ability to exit their investment if necessary.

Regulatory Complexity – Managing alternative investment funds involves meeting specific regulatory requirements, both domestic and EU.

Summary

Alternative investment companies are an attractive form of investment that offers great flexibility in terms of asset selection and investment strategies. Based on the provisions of the Act on Investment Funds and on the Management of Alternative Investment Funds, alternative investment companies can invest in a wide range of alternative assets, which allows for the implementation of complex investment strategies, but at the same time involves higher risk. For this reason, alternative investment companies are mainly aimed at professional investors and require extensive experience in investing.

Artykuł Alternative Investment Companies – practical comments pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

On January 15, 2024, there will be held the event KRAKÓW: City – space for business. Synergy for the reconstruction of Ukraine. The event is organized by the Polis-Ukrainian Chamber of Commerce within the framework of the social campaign “Partnership and Employment” and the project “Work for Reconstruction of Entrepreneurship in Ukraine.” The event will provide a unique platform for diverse professionals, thought leaders, and stakeholders to come together and discuss critical issues surrounding urban development, business opportunities, and collaborative efforts for the reconstruction of Ukraine. The conference will cover a wide range of topics such as urban planning, sustainable development, and the role of businesses in contributing to the reconstruction efforts in Ukraine. Renowned experts and speakers will share valuable insights, best practices, and innovative ideas, fostering a rich exchange of knowledge and experience. Participation in the Conference will be an enriching experience. The insights we will gain and connections made will undoubtedly contribute to our professional growth. The event will be participated by Weronika Mazurek on behalf of KIELTYKA GLADKOWSKI KG LEGAL.

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Artykuł <strong>KIELTYKA GLADKOWSKI KG LEGAL TAKES PART IN THE EVENT “KRAKÓW: City – space for business. Synergy for the reconstruction of Ukraine”, January 15, 2024</strong> pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

KIELTYKA GLADKOWSKI KG LEGAL takes part in the project “Systemic Design and Sustainable Healthcare for MedTech Manufacturing (SysteMA)”. One of elements of the project is led by the Life Science Cluster in Krakow and the MedSilesia cluster. The latter became involved in activities to raise awareness and knowledge in the field of the circular economy.

The research is part of the EIT Manufacturing project SysteMA (Systemic Design and Sustainable Healthcare for MedTech Manufacturing), which focuses on the role of MedTech manufacturing towards the environmental, social, and economic sustainability of healthcare systems. The project aims to create online training courses on this topic, providing EU companies with actionable skills to improve the sustainability of their products and processes and seize new market opportunities.

The aim of the research is to define the sustainability knowledge and actions that EU MedTech companies have already undertaken. This will allow project partners to define effective training paths according to the actual state of the sector.

The demand for green procurement, sustainable products/services, and higher environmental standards, is set to increase dramatically. However, companies, especially SMEs, have few tools to fill the knowledge gaps on sustainable healthcare issues. The training programme aims to address this need by offering learning paths tailored according to the starting level and the sustainability goals that professionals and students in the MedTech industry aim to acquire.

The action is carried out as part of the project “Systemic Design and Sustainable Healthcare for MedTech Manufacturing (SysteMA)”, in which, apart from the Life Science Cluster, there participate the University of Technology in Turin (ITALY) – Project Leader and partners: Bioindustry Park Silvano Fumero SpA (ITALY), TEM at Lund University / Nordic Center for Sustainable Healthcare (SWEDEN), Stryker (IRELAND); GVS Group – (ITALY).

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https://www.eitmanufacturing.eu/news-media/activities/systemic-design-and-sustainable-healthcare-for-medtech-manufacturing-systema/

Artykuł <strong>KIELTYKA GLADKOWSKI KG LEGAL IS INVOLVED IN THE PROJECT “SYSTEMIC DESIGN AND </strong>KIELTYKA GLADKOWSKI KG LEGAL IS INVOLVED IN THE PROJECT “SYSTEMIC DESIGN AND SUSTAINABLE HEALTHCARE FOR MEDTECH MANUFACTURING (SYSTEMA)”<strong> FOR MEDTECH MANUFACTURING (SYSTEMA)”</strong> pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

On November 17, 2021, Pracuj.pl group, a leader in the digital recruitment market, operating in Poland, offering services to support the recruitment, retention and development of employees has published a prospectus with a view to conducting an initial public offering of the Company’s shares and their admission to trading on the main market of the Warsaw Stock Exchange. The offer covered up to 22,380,626 existing shares with each share having a nominal value of PLN 5 – representing 32.86% of the share capital. The maximum price has been set at PLN 82 per share.

Book building

Before the sale of shares takes place, the company conducts book-building, which is a key process in determining the share issue price. The book of demand thus involves the collection of non-binding information from potential institutional investors on their interest in acquiring the securities in question. The key stage affecting book building is the acceptance of subscriptions from potential investors, and on the basis of the interest in the offer the company determines the issue price and the final number of shares.

Subscription for shares

The method of subscribing to a share experiences differences depending on the category of investor – individual or institutional. In the case of an individual investor, the first requirement is to have a securities account open with the investment firm with which he intends to place such a subscription. Subsequently, subscriptions for shares must be made on subscription forms available at customer service points of investment firms, by fax, by telephone or by other electronic means. Retail Investors will place subscriptions at the maximum price, indicating the number of offered shares they intend to purchase.

As far as institutional investors are concerned, the entire subscription process starts once the book-building is completed. Then, after a discretionary selection by the responsible entities, invitations to subscribe are sent to investors, which entitle them to subscribe for a specific number of shares at a specific price. They are made in writing, on a special form made available by the relevant brokerage house.

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However, the shareholder of the share thus acquired will not be the literal owner of the share, as this right accrues to the majority shareholder of the company upon completion of the offer, as this is a public offer of existing shares to which current shareholders are entitled. Nevertheless, shareholders have rights attached to their shares under the Companies Act and other laws. This matter may also be regulated by a special agreement entered into by the shareholders.

Role of the prospectus

The prospectus is, in a sense, an offer made to potential investors, by outlining the financial benefits of the investment, is intended to encourage new shareholders to put their capital into the company. Taking Pracuj Group’s prospectus as an example, it presents the amounts of dividends paid in the past and the current dividend policy, which indicates that at least 50% of net profit will be distributed to shareholders. Moreover, a large part of the prospectus is devoted to the company’s financial results, its development plans and usually optimistic financial forecasts, which are supposed to convince as many investors as possible, that this is a profitable venture.

KIELTYKA GLADKOWSKI KG LEGAL advises on current basis individual and corporate investors at all stages of investment process in Poland, with a particular emphasis on cross border shareholding structures.

Bibliography:

1. https://grupapracuj.pl/oferta-publiczna ,

2. Prospekt Grupa Pracuj S.A., online: https://grupapracuj.pl/wp-content/uploads/2021/11/Prospekt-spolki-Grupa-Pracuj-SA.pdf .

Artykuł <strong>Foreign individual investors in the prospectus of shares of the e-commerce industry – principles of investing in securities in Poland</strong> pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

On August 24, 2018, the Polish Ministry of Finance published a draft act amending the act on personal income tax, the act on corporate income tax. One of the proposed changes was the introduction of preferential taxation of income from intellectual property rights (the so-called “IP Box” or “Innovation Box” relief).

Innovation Box – IP Box allowances – were introduced to the Polish Personal Income Tax Act (“PIT”) and to the corporate income tax (“CIT”) as a preferential form of taxation (preferential taxation of earned income) for entrepreneurs obtaining income from commercialization of intellectual property rights. Qualified intellectual property rights are obtained after submitting an application to the appropriate body – then it is possible to take advantage of this relief.

IP Box has been implemented in other countries, including: the Netherlands, Great Britain, Ireland, Luxembourg.

The mechanism used in these countries consists in taxing income from intellectual property rights with a reduced tax rate (e.g. in Great Britain – 10%) or exempting part of tax revenues (e.g. 80% in Luxembourg). IP Box Relief is available to increase one’s company’s knowledge resources or to protect intellectual property. It can also be used by those who want to register an industrial design as part of research and development.

Regulations on preferential taxation of intellectual property rights should be consistent with the OECD guidelines under the Base Erosion and Profit Shifting (BEPS) initiative.

The subject of taxation covered by the IP Box

The preferential rate of income tax – 5% of the tax base – will be applicable to income from qualifying intellectual property rights created, developed or improved by the taxpayer as part of its R&D activities. The basis for granting the IP Box tax relief is the fulfillment of several conditions. More precisely, it is possible in the case of using knowledge resources and research and development works related to: rights to an invention (patents), additional protection rights for an invention, utility model rights, rights from registration of an industrial design, rights from registration of integrated circuit topography, additional protection rights for a patent for a medicinal product or plant protection product, legal protection of plant varieties, creating new applications, rights from registration of a medicinal or veterinary product, rights from registration of new plant varieties and animal breeds, rights to a computer program.

The above rights must be legally protected on the basis of the provisions of separate acts or ratified international agreements to which Poland is a party or other international agreements to which the European Union is a party. The draft also allows for the appropriate application of its provisions on qualified intellectual property rights to persons waiting for these rights (additional protection right), provided that the taxpayer submits an application to the competent authority.

Conducting research and development activities – qualified intellectual property right

The IP Box relief applies to those intellectual property rights that are created, developed or improved by the taxpayer as part of R&D activities. It is indicated that the application of the relief is permissible if the taxpayer is the owner, co-owner, user or has the right to use the above-mentioned intellectual property rights. The Innovation Box tax relief may also be used in the event that the taxpayer acquires the results of research and development, provided that he then incurs costs related to the development or improvement of the acquired right.

Tax rate, income tax in the field of IP Box – Polish Ministry of Finance

The tax rate on qualified income earned by the taxpayer from the intellectual property rights discussed above will be 5% of the tax base. Accordingly, the tax base will be calculated as the sum of revenues from qualifying intellectual property rights in a given tax year.

Income (loss) for the purposes of claiming IP Box relief – income calculation

Income / loss on qualifying intellectual property rights includes income / loss from: fees or commissions resulting from a license for a qualified intellectual property right, sale of qualifying intellectual property rights, qualifying intellectual property rights included in the selling price of products or services, compensation for infringement of qualifying intellectual property rights, if obtained in court proceedings, including arbitration proceedings.

Losses on qualifying intellectual property rights incurred in a given tax year will reduce income from the same qualifying intellectual property right or the same type of product or service or the same group of products or services in which the intellectual property right has been used for 5 consecutive tax years.

What is the period of application of the IP Box relief to the qualified intellectual property right?

The taxpayer has the right to benefit from the tax relief for the entire period of legal protection of the entitled intellectual property rights. In the case of property components subject to the application / registration procedure (waiting to obtain a qualified intellectual property right), the taxpayer has the right to benefit from tax preferences from the moment of submitting the application for registration (however, the taxpayer will be obliged to refund the amount in the event of withdrawal of the application, refusal of registration or rejection of the application).

Qualified intellectual property rights – criteria to be met in order to obtain relief

The Polish IP Box tax relief is available from January 1, 2019. This is a preferential CIT / PIT rate of 5% on the taxpayer’s income from commercialization of qualifying intellectual property rights. In order to use the IP Box, 4 basic criteria must be met:

a) to conduct research and development activities;

b) to cover the results of R&D activities with legal protection in accordance with the list of authorized intellectual property rights. Qualified intellectual property rights are, inter alia, patents, utility models, industrial designs, the right to register an integrated circuit design, an additional protection certificate for a patent for a medicinal product or plant protection product, copyrights to computer programs;

c) to identify the costs of R&D activities carried out, which led to the entrepreneur obtaining a qualified intellectual property right (the key is to keep detailed accounting records);

d) to identify the commercialization of qualifying intellectual property rights, e.g. by selling or levying royalties on qualifying intellectual property rights.

IP Box and R&D relief

The IP Box relief and R&D complement each other. The first one includes a preferential tax rate on income from the commercialization of intellectual property rights. They have to be created, developed or improved through the research and development activities carried out by the enterprise. R&D tax relief reduces the tax base for conducting R&D activity.

To qualify for the IP Box tax credit, one must engage in R&D

The IP Box tax relief consists in taxing at the preferential tax rate only income obtained from qualifying intellectual property rights that have been produced, developed or improved by the taxpayer as part of his research and development activities. Therefore, one cannot claim the IP Box tax credit without doing R&D.

Artykuł IP BOX TAX RELIEF IN POLAND pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.