A new era is set to begin in European pharmaceutical law: after more than twenty years, the European Union is comprehensively revamping its pharmaceutical regulations, which could fundamentally transform the way the pharmaceutical industry operates. The Pharmaceutical Package aims to enable faster access to affordable medicines, encourage innovation, strengthen the competitiveness of the industry, while also paying attention to the significance of sustainability. Our article summarizes the main elements of the planned changes and their expected impact on manufacturers.

In early September, the French data protection authority issued a precedent-setting decision: it fined Shein’s Irish subsidiary for serious violations of cookie and user consent regulations. The ruling goes far beyond a single fine and sends a clear message: cookie-related data protection rules must be taken seriously.

For international investors, acquiring or establishing a business in Hungary involves more than negotiating commercial terms. Mergers, acquisitions, and joint ventures may require approval from the Hungarian Competition Authority (“HCA”) before they can be completed. Failure to comply with merger control rules can result in significant fines, delays, or even the prohibition of a transaction.

At the beginning of the summer, the regulations governing the land registry in Hungary were amended, introducing significant changes affecting owners of so-called garden plots in the outskirts ( in Hungarian: “zártkerti ingatlanok”), such as weekend houses, garden homes, and similar plots. The practical benefits, however, will largely depend on the location and on whether the local municipality allows their application.

The EU AI Act introduces the first comprehensive and binding regulatory framework for artificial intelligence in the European Union. From 2026, Hungarian companies that develop, deploy or use AI systems will be subject to extensive legal, governance and documentation obligations, with enforcement risks comparable to those under GDPR.