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.
We are glad and honoured to inform you that our law firm KIELTYKA GLADKOWSKI contributed the chapter, next to the Colleagues from the Kingdom of Saudi Arabia and United States, about the legal status of anti-money laundering provisions and expected changes in law from Polish perspective. We kindly invite you to read the chapter.
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.
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.
