The limits of trade in medicinal products in Poland are strictly defined by legal regulations. The main source regulating the sale of medicines is the Act of 6 September 2001 – Pharmaceutical Law (Journal of Laws of 2024, item 686, as amended) (hereinafter referred to as “Pharmaceutical Law”). Art. 2, point 32 of the aforementioned Act states that a medicinal product is a substance or mixture of substances presented as having properties for the prevention or treatment of diseases occurring in humans or animals or administered for the purpose of making a diagnosis or for the purpose of restoring, improving or modifying the physiological functions of the body through pharmacological, immunological or metabolic action. Pharmaceutical Law presents principles that define the rules of trade in such products.
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Publication date: March 05, 2025
Methods of transporting medical samples
Transport of medical samples is an essential element of the laboratory diagnostics process, the primary goal of which is to ensure the integrity, stability and quality of biological material at every stage of its movement – from the moment of collection to analysis in the laboratory. Properly organized transport minimizes the risk of sample degradation, contamination, loss of their diagnostic value and potential biological threats to medical personnel and the environment. In addition, precise adherence to transport standards, including appropriate temperature conditions, delivery time and compliance with applicable regulations and procedures, is crucial for obtaining reliable laboratory test results. Below are the main methods of securing medical samples by suppliers during transport.
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Publication date: March 05, 2025
The AI Act is a regulation adopted by the European Union regulating the use of artificial intelligence in various sectors of the economy, including health, finance and public administration. It is a groundbreaking legal act in this matter. The AI Act has a particular impact on the life science sector, as companies related to the medical industry are increasingly using artificial intelligence in biomedical research, diagnostics and the development of new therapies. The regulation introduces new regulations that entities related to the life science sector are required to implement by August 2026.
The regulation must be complied with by both EU and non-EU entities if they introduce or use AI systems on the EU market (Article 2 (c) AI Act ). Importantly, AI systems used solely for research, innovation, non-professional activities, national security, defence and military purposes are not subject to AI ACT regulations.
Regulatory context
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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 05, 2025
The ongoing digitalization of the healthcare sector in Poland brings new opportunities, but also challenges related to personal data protection and improving process efficiency. One of the latest achievements in this area is the introduction of the Health ID application, which aims to simplify and secure the process of confirming patients’ identity during the implementation of e-prescriptions. The new application, developed as part of the Potential Project, is an innovative solution that changes the approach to patient identification, while responding to the needs of modern data security standards [1].
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