Kategorie: EU Law
Pharmaceutical Package: A Major Reform of EU Pharmaceutical Legislation
On 11 December 2025, representatives of the Council of the European Union and the European Parliament reached a political agreement on a new framework for pharmaceutical legislation, the so-called EU Pharmaceutical Package.[1] This represents a comprehensive reform of EU pharmaceutical law and the most extensive revision of the rules governing medicinal products in more than …
Read moreThe rule of precedence in EU law and the boundary between medicinal products and foods considering the judgment of the Court of Justice of the European Union in Case C 451/24
The European market is increasingly confronted with products whose nature lies at the boundary between medicinal products, food supplements, and foods for special medical purposes, thereby creating significant regulatory uncertainty for both businesses and national authorities. In this context, the judgment of the Court of Justice of the European Union in Case C‑451/24 of 4 …
Read moreDigital Omnibus: proposed changes to the Data Act in the EU’s digital era
On 19 November 2025, the European Commission (the Commission) presented the first official proposal for the Digital Omnibus legislative package[1], whose main objective is to modernise and clarify European digital law. The Digital Omnibus is currently in the proposal stage. Background In our previous article, we focused on how Digital Omnibus affects personal data protection …
Read moreDigital Omnibus: proposed changes to the GDPR in the EU‘s digital era
On 19 November 2025, the European Commission (hereinafter the “Commission”) presented the first official draft of the Digital Omnibus legislative package[1], whose main objective is to modernize and clarify European digital law. In general Digital Omnibus, which is currently in the proposal stage, brings fundamental changes, particularly in the area of personal data protection under …
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