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DUTCH SANDWICH – IS IT LEGAL + additional comments about company in Samoa

Publication date: March 31, 2025

Is CIT optimization by two companies in Dutch jurisdiction legal?

Legality in the light of Polish and international law

Market Principle and Transfer Pricing

According to Polish transfer pricing regulations (Articles 11a–11t of the CIT Act) and OECD guidelines, transactions between related entities must be agreed on arm’s length terms principle. If the tax authorities consider that transactions between a Polish and a Dutch company are not arm’s length, they may:

  • Estimate the income of the Polish company and impose outstanding CIT.
  • Impose a penalty tax rate (50% CIT – Article 19, Section 4 of the CIT Act).
  • Apply criminal and fiscal sanctions against the company’s management.

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KIELTYKA GLADKOWSKI KG LEGAL TOOK PART IN LIFE SCIENCE CLUSTER WEBINAR ON CERTIFICATION OF MEDICAL DEVICES

Publication date: March 31, 2025

The meeting was devoted to the classification of medical devices. The main topic was the technical and legal classification and certification of medical products and diagnostic devices before they are introduced to the market. This process is very time-consuming and even very expensive.

It is worth using the help of a company that provides assistance in this procedure during this process. It is important that this company is a notified body, a conformity assessment body designated in accordance with Regulation 2017/745. Then you can be sure that a given product intended to take care of human health will be properly put into clinical trials and will be safe for people.

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Connected Health Ecosystems via Open Innovation (COHES.io) – A New Era of Health Innovation digital

Publication date: March 31, 2025

The healthcare sector is one of the most challenging areas of innovation, characterized by high complexity, strict regulations, high development costs and cultural diversity in different countries. Despite technological progress, fragmentation of innovation ecosystems in digital health is a significant barrier to effective cooperation and implementation of new solutions. The COHES.io project (Connected Health Ecosystems via Open Innovation), which aims to create an interregional space for open innovation in digital health, is the response to these challenges.

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Permission to manufacture or import a medicinal product – administrative procedure and detailed requirements for factories

Publication date: March 31, 2025

In recent years, there has probably been no more dynamically developing market sector than that closely related to the production of drugs, their testing and introduction to consumer circulation. Especially during the COVID-19 pandemic caused by the SARS-CoV-2 coronavirus, all the efforts of pharmacists around the world have been focused on developing an effective formula for a vaccine protecting against infection with this disease, producing it, testing it and making it available to people, and in the longer term on developing a formula for a drug that could be widely used, e.g. in hospitals. No less important at that time were the problems and legal issues related to obtaining permission to produce drugs. In this article, there will be discussed detailed regulations related to the procedure for obtaining consent to manufacture drugs, which is regulated in the Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2024, item 686; amended: Journal of Laws of 2025, item 129), as well as to present the requirements imposed on drug factories in terms of building equipment and production principles, which are regulated in other sub-statutory legal acts.

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NEW LEGAL500 RANKING 2025

Publication date: March 26, 2025

KIELTYKA GLADKOWSKI KG LEGAL AGAIN CONFIRMS ITS LEADING POSITION IN POLAND

We are honoured and very pleased to inform that according to the new ranking of the Legal500 for 2025 KIELTYKA GLADKOWSKI KG LEGAL has been ranked as the leading law firm in Poland. We have been ranked in three major categories: Data Privacy and Data Protection; Healthcare and Life Sciences; Private Client.

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