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AI Act Regulation – latest provisions entering into force

Publication date: February 24, 2025

Regulation 2024/1689 (AI Act) is the first regulation of the issue of artificial intelligence in EU law. It was issued in response to concerns related to the use of AI, including the risks of manipulation, surveillance and unequal treatment of citizens. The first provisions of the AI Act entered into force on 2 February 2025. They cover primarily the issues of AI literacy, prohibited practices and high-risk AI.

AI literacy

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On February 25, 2025, Jakub Florek, of KIELTYKA GLADKOWSKI KG LEGAL will take part in the SGH Business competition, which is organized on-site, on the SGH campus in Warsaw.

Publication date: February 24, 2025

Although the SGH Business Game may be associated with the broadly understood field of management, it is worth emphasizing that participation in this competition is not limited only to people associated with economic sciences. Law students, participating in the competition, get to know issues in the field of management, negotiations or business law.

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KIELTYKA GLADKOWSKI KG LEGAL PARTICIPATED IN THE LIFE SCIENCE CLUSTER WEBINAR – THE IMPACT OF THE AI ACT ON LIFE SCIENCES MARKET

Publication date: February 20, 2025

Today (February 20) we had participated in the webinar organised by the Life Science Cluster, devoted to the impact of the AI Act regulation on the life science sector – its importance and consequences for entrepreneurs.

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Legal Report: Framework for the regulatory freedom of information to the patient about the drug – comparative analysis on the example of TWO SIMILAR eye ointments

Publication date: February 19, 2025

Introduction: The ambivalence of the issue and the regulatory context

The issue of informing the patient about the drug is of key importance in the treatment process, because the proper provision of information can affect the effectiveness of the therapy, patient safety and minimizing the risk of adverse effects. From a regulatory perspective, the rules regarding drug leaflets are precisely defined in both national and EU legal acts, but in practice we encounter differences in the formulation of this information by manufacturers, even in relation to products intended for the treatment of the same condition.

A comparative analysis based on the example of the comparative leaflets of two sample drugs, Maxitrol and Floxal – two preparations used in the treatment of blepharitis, although differing in composition and mechanism of action – reveals a certain editorial freedom of the manufacturers in shaping the content of the leaflets.

On the one hand, the law regulates in detail the requirements for the content of leaflets, on the other hand, there is flexibility in their formulation, especially in stylistic and organizational matters. The aim of this report is to provide an in-depth analysis of the legal provisions regulating this issue, as well as to present a comparison of two leaflets, taking into account both their substantive content and form.

Report objectives:

  • Understand the laws that govern prescription drug information leaflets.
  • Analysis of the details of the presentation of active substances, dosage, contraindications, etc.
  • An assessment of the extent to which the drug manufacturer has freedom to edit such information and what the legal consequences of these choices are.

Legal Basis for Prescription Drug Disclosure Obligations

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Possibilities, limitations and risks of establishing a civil law relationship between an employer and a former employee

Publication date: February 19, 2025

Employers often address the question whether it is legal and possible to end employment relationship with the employee and enter into civil law relationship or B2B contract.

This article presents possibilities, risks and limitations of replacing employment contract with civil law contract.

At the outset, it is worth paying attention to the legal provision of the Polish Labour Code, namely Article 22 § 1, which states that:

“§ 1. By entering into an employment relationship, the employee undertakes to perform work of a specified type for the employer and under his supervision and at the place and time designated by the employer, and the employer undertakes to employ the employee for remuneration.”

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