Publication date: January 21, 2026
Every drug introduced to the EU market must obtain a permit from the competent authority. In Poland, this is the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. EU regulations included in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, implemented into Polish law by the Act of 6 September 2001 – Pharmaceutical Law provide for several procedures enabling drug registration, one of which is the so-called well-established medicine procedure (WEU). This is a special procedure for obtaining marketing authorization for medicines containing active substances with well-established medical use, i.e., medicinal substances known and systematically used in the EU for at least 10 years. The most important difference with this procedure is that there is no need to submit new clinical and pre-clinical studies, and the application can be based on available scientific studies that confirm the effectiveness and safety of the substance.
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Publication date: January 21, 2026
Business concentrations are common and significant phenomena that constitute a part of modern economic activity. They include takeovers, mergers, the acquisition of assets, and even the creation of joint ventures. Their primary goal is typically to develop companies and increase competitiveness and efficiency. They can also lead to a restriction of market competition. Therefore, the legislature has introduced the obligation to notify the President of the Office of Competition and Consumer Protection (UOKiK) of any intended concentration in cases where it may affect competition conditions in Poland. This article will discuss when an enterprise must notify the President of the Office of Competition and Consumer Protection (UOKiK), what information should be included, and the procedure conducted by the President of the UOKiK.
Reporting the intention to concentrate
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Publication date: January 20, 2026
Foreign direct investment (also known as FDI) is a form of capital investment in which an investor from one country acquires a permanent stake in a particular enterprise operating in a foreign market, thereby gaining real influence over its operations. This cash flow is long-term and serves not only to generate financial profits but also to provide operational and strategic control over the foreign entity. Through foreign investment, the investor can acquire a significant stake in the company’s ownership structure, and therefore hold at least 10% of the company’s share capital. Often, the decision to conduct such investments involves more than just transferring capital; the investor also invests resources, modern technology, and management staff, ensuring the efficient operation of the foreign entity. These investments can take various forms, from the construction of new plants to the acquisition of existing enterprises. In each of these situations, the investor is responsible for managing and shaping the entity’s market situation, which is the difference between foreign direct investment and passive forms of capital investment. Moreover, unlike short-term investments, FDI typically represents a long-term commitment to a specific foreign market, requiring compliance with specific regulations and meeting various requirements. Investors must primarily consider the target country’s political stability, the availability of qualified labor, and the potential for economic growth. Foreign direct investment currently constitutes one of the foundations of globalization and the integration of global markets.
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Publication date: January 20, 2026
In the Polish legal system, competition protection regulations, particularly the Act of 16 February 2007 on Competition and Consumer Protection provide for the possibility of imposing financial penalties not only on enterprises but, since the amendment to the 2015 Act, also on individuals managing enterprises. In recent years (in fact, such a sanction was first applied in 2020), the President of the Office of Competition and Consumer Protection (UOKiK) has been increasingly using this mechanism. This article will discuss key legal provisions concerning the liability of managers and the practices of administrative bodies in imposing sanctions.
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Publication date: January 20, 2026
Analysis of Commission Regulation (EU) No 2023/2055
EU Commission Regulation 2023/2055 expands Annex XVII of Regulation (EC) 1907/2006 (REACH) by adding entry 78. Annex XVII consists of a list of organic substances to varying degrees. Regulation 2023/2055 was introduced to restrict the use of synthetic polymer microparticles, often referred to as microplastics. However, it should be noted that the definition in the Regulation is broader than the commonly understood definition of microplastics. This initiative aims to reduce their release into the environment, as it is estimated that currently 42,000 tons of intentionally added microplastics enter the environment each year. The Regulation entered into force in 2023, but many provisions will not enter into force until the coming years.
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