European Union: Food and Drugs Law

The Council of the European Union has formally adopted the EU Pharma Package, marking the most significant revision of EU pharmaceutical legislation since 2004. This comprehensive reform introduces substantial changes to regulatory protection periods, innovation incentives, medicine shortage protocols, and market access mechanisms that will fundamentally reshape how pharmaceutical companies operate across the European Union.

Since July 2026, veterinary medicines manufacturers have been subject to restructured good manufacturing practice (GMP) rules under two new EU Regulations. These standalone frameworks introduce mandatory quality obligations for finished products and active substances, replacing previous guidance-based requirements with directly applicable law. Meanwhile, the European Commission's proposed Biotech Act I aims to streamline variation procedures, simplify GMO approvals, and introduce new incentives for biotechn

The Council has adopted its position on the EU Pharmaceutical Package at first reading, with legally and linguistically revised texts now available. While the main elements of the political compromise remain intact, several clarifications warrant attention as companies refine their implementation plans and the legislative process continues toward completion.

Με βάση τα στοιχεία που τηρούνται στα Επαρχιακά Γραφεία Εργασίας, ο αριθμός των εγγεγραμμένων ανέργων στο τέλος Ιουνίου 2026 ανήλθε σε 10.056 άτομα. Με βάση τα εποχικά διορθωμένα στοιχεία, τα οποία αποτυπώνου

Novagraaf presents a webinar exploring the intersection of alcoholic beverages and counterfeiting, examining the challenges brands face in protecting their products from fraudulent reproduction. The session will address key intellectual property concerns and enforcement strategies specific to the alcohol industry.

The European Commission has published a comprehensive roadmap to phase out animal testing for chemical safety assessments by 2026, outlining 22 concrete actions across 15 legislative domains. While the communication itself is non-binding, it signals significant regulatory changes ahead that will reshape data requirements, testing strategies, and compliance obligations for businesses operating in pharmaceuticals, chemicals, and related sectors.

The access conditionality under Article 56a has shifted from an incentive (“carrot”) to a penalty (“stick”) — Member States can request marketing authorization holders (MAH) to launch and supply products...

On 20 April 2026, the Dutch government published a draft Implementation Act setting out the national governance structure for AI supervision under the AI Act.

In our sixth alert in this EU Pharma Package Series, we provided an analysis of the history and interpretation issues for another highly debated topic: the “Bolar” exemption.