Biostimulants in aesthetic medicine – current regulatory challenges for manufacturers, distributors and clinics
The aesthetic medicine market is currently one of the fastest-growing healthcare segments in Europe. Particularly dynamic growth is observed in so-called tissue biostimulants, preparations used to stimulate the body’s natural regenerative processes. While traditional fillers dominated just a few years ago, today both manufacturers and physicians are increasingly turning to preparations containing poly-L-lactic acid (PLLA), calcium hydroxyapatite, polynucleotides, and collagen preparations, whose mechanism of action is based on the stimulation of tissue regeneration processes rather than solely on mechanical effects.
The phenomenon of fake reviews in the digital space has evolved from a marginal image issue to a central focus of market supervision authorities and EU legislators. The contemporary ontology of this phenomenon extends beyond primitive content fabrication to encompass any form of communication that, by distorting the actual consumer experience, misleads the recipient, directly influencing their decision-making process. Legally, a fake review is considered not only a completely false message, but also one that, by omitting important facts or manipulating context, creates a false impression of the quality of a product or the reliability of a seller. This practice is classified as unfair commercial activity if its nature causes or is likely to cause the average consumer to make a transactional decision they would not otherwise make, thus violating the fundamental principles of fair dealing.
The draft Act of April 13, 2026, amending the Act on Food and Nutrition Safety will enter into force six months after its publication. The new regulations primarily impact producers, importers, distributors, and sellers of dietary supplements – both in traditional and online channels. Below, we present the real changes to your business.
We are delighted to share an important milestone in the continued development of KG Legal’s Data, AI & Cybersecurity Desk.
It has been a great honour to serve as the exclusive expert contributors for Poland to the OneTrust DataGuidance Privacy Overview – Poland, one of the world’s leading professional legal compliance resources relied upon by in-house counsel, privacy professionals, compliance officers, multinational organisations and technology companies operating across multiple jurisdictions.
The Act amending the Act on the National Cybersecurity System aims to implement Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 (NIS Directive 2) and the partial application of Commission Delegated Regulation (EU) 2024/1366 of 11 March 2024 supplementing Regulation (EU) 2019/943 of the European Parliament and of the Council.
The amendment to the KSC Act significantly expands the scope of the regulations and introduces new obligations in the field of cybersecurity management. The changes include, among other things, the implementation of risk management systems and expanded incident reporting requirements. The new regulations also strengthen the powers of supervisory authorities and significantly increase the maximum amount of financial penalties. It also introduces liability for the management staff (manager) of an entity. In practice, this requires certain entities to take steps to comply with the new regulations.
