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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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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Publication date: February 18, 2025
The classically understood merger and acquisition in Polish legal doctrine concern issues closely related to private economic law. In the classical understanding of these concepts, a merger is a combination of two or more companies as a result of which they create one entity. A takeover also occurs in the Polish legal system, but this institution differs from a merger. As a result of a takeover, no new legal entity is created, and the acquiring company gains control over the assets and activities of the acquired company. Both institutions are regulated by the Commercial Companies Code, where both of these institutions are regulated in Title IV of the aforementioned code. The M&A can also be understood more broadly, as the purchase of technology or organised part of the enterprise.
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Publication date: February 17, 2025
What is user tracking and how common is it?
Tracking users online is a complex process of collecting and analyzing data about Internet users’ online activities. This includes monitoring websites visited, interactions with content, search terms, and other actions taken online. The main goal of this process is to create detailed user profiles that allow for content personalization, precise advertising targeting, and in-depth analysis of consumer behavior. Online tracking methods are based on many techniques, such as:
a/ Cookies: These are small text files saved on users’ devices by visiting a website. They enable remembering preferences and tracking movement between websites. Using this type of file allows maintaining the user’s session of the website after logging in, so that the user does not have to re-enter their login and password on each subpage. The types of cookies currently used are temporary files and permanent files. Temporary files are stored until the page is closed, and permanent files are stored for a specified period of time specified by the parameter contained in the “cookie” file. Currently, web browsers include an option that allows the user to clear cookies.
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Publication date: February 17, 2025
EORI – basic information
EORI, or Economic Operators Registration and Identification, is a system for identifying economic operators used in the European Union to streamline and standardize customs procedures and ensure effective control of operations related to international trade. The introduction of the EORI number results from EU regulations governing the functioning of trade in goods with third countries and is a key element of EU customs policy.
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