Publication date: October 07, 2025
Pharmacovigilance under Polish law
The purpose of an inspection of the pharmacovigilance system for medicinal products intended for human use (pharmacovigilance inspection) is to verify how the marketing authorization holder for medicinal products is fulfilling its obligations regarding the pharmacovigilance system imposed by Polish and European Union law.
Publication date: August 21, 2025
Application in medicine
Laughing gas, or nitrous oxide (N2O), is legal in Poland and used exclusively for medical purposes by authorized entities such as hospitals and private clinics. Its medical uses include anesthesia during dental, surgical, and gynecological procedures, as well as pain management. In medicine, nitrous oxide is considered a medical device or medicinal product, depending on its use and form. In medical practice, it is a medicinal gas used under the supervision of qualified personnel, meaning its sale and use are strictly regulated. In Poland, nitrous oxide is available in pharmacies and pharmaceutical wholesalers, but only by prescription and to medical entities.
Publication date: June 23, 2025
Regulations on the safety of food contact materials and limiting the impact of plastics on the environment
Regulation (EC) No 1935/2004 and Directive (EU) 2019/904 are two key pieces of legislation that aim to protect public health and the environment, focusing on materials and articles intended to come into contact with food and reducing the environmental impact of single-use plastic products.
Publication date: June 18, 2025
In the era of digitalization and the growing role of data in the economy, patients’ medical information is becoming not only the subject of legal protection, but also a significant economic resource. Sensitive data – including treatment history, diagnoses, test results or genetic information – is increasingly treated by entities operating in the healthcare sector as a potential asset. Used for analytical, research and sometimes commercial purposes, it is becoming an element of the business strategy of medical, biotechnological or technological companies. However, such an approach raises a number of legal, ethical and social questions. Can patients’ personal data be perceived as a commodity? What are the boundaries of personal data protection regulations, such as GDPR? And finally – is it possible to reconcile business interests with the patient’s right to privacy and autonomy?
This article will discuss the above issues in the context of Polish and EU law.
Publication date: June 02, 2025
The new organizational model of Primary Health Care facilities and the introduction of the institution of a medical proxy have been in force since 1 January 2025. It has introduced changes to the functioning of primary health care, primarily through the creation of teams consisting of a family doctor, nurse and midwife, who jointly provide care for the patient. Nurses and midwives will cease to function as independent practices with their own patient lists. From 2025, they will form teams with primary health care doctors, which means that when a patient chooses a doctor, they automatically accept the entire care team. Patient declarations about choosing a specific nurse or midwife lose their validity. This raises concerns, because approximately 1,600 entities run independent nursing and midwifery practices, serving approximately 8 million patients, which may lose the ability to continue operating after the changes, moreover, the regulations do not specify precisely the principles on which independent nursing and midwifery practices are to be included in primary health care teams, which raises uncertainty and even greater concerns among the nursing community.
