24 results found

The Swedish Supreme Administrative Court has issued a landmark judgment clarifying how to determine whether mixed contracts involving both existing leased premises and new construction fall under public procurement rules or the lease exemption. The case examined a municipality's lease agreement covering both existing school premises and a landlord-constructed extension, raising critical questions about contract classification when elements of both lease and works contracts are present.

The European Commission has proposed replacing the EU's three public procurement directives with a single, directly applicable regulation that would fundamentally transform how public contracts are awarded across Member States. This comprehensive reform aims to simplify procurement procedures, strengthen economic security through European preference principles, and elevate environmental and social considerations to strategic priorities. The proposal introduces extensive digitalisation measures and consolida

Travel platforms face evolving regulatory scrutiny as package travel rules expand beyond traditional tour operators. Product design, marketing strategies, and booking flow decisions now carry significant...

The European Commission has launched the Digital Product Passport Registry and testing environment, establishing critical infrastructure for businesses to register products under the EU's Ecodesign...

A UK court has ruled on the validity of Novartis's supplementary protection certificate for Entresto, examining whether the SPC product should be defined as the specific co-complex formulation or the broader...

The EU's Cyber Resilience Act introduces mandatory vulnerability and incident reporting obligations for manufacturers of digital products starting 11 September 2026, well before the broader regulatory framework takes effect. Manufacturers must navigate tight reporting deadlines, determine when they become "aware" of security events, and establish governance structures to comply with 24-hour early warnings and subsequent detailed notifications through a platform that is not yet operational.

ICANN received over 1600 applications for new generic top-level domains (gTLDs) after closing its application window in August 2026. With Reveal Day set for October 7, 2026, brand owners must prepare to review published strings and consider filing legal rights objections by the March 16, 2027 deadline to protect their trademarks from potential infringement.

The European Union's new Anti-Money Laundering Regulation introduces sweeping changes for the automotive sector, bringing luxury vehicle dealers into the compliance framework for the first time while imposing stricter requirements on leasing companies. With motor vehicles priced above EUR 250,000 now classified as high-value goods, dealers must implement comprehensive AML procedures including customer due diligence, beneficial ownership verification, and mandatory reporting to financial intelligence units

The Authority for Anti-Money Laundering and Countering the Financing of Terrorism (AMLA) has released draft guidelines on ongoing monitoring of business relationships under the new Anti-Money Laundering Regulation.

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.

The European Union's transparency obligations under Article 50 of the AI Act are now in force, requiring companies to disclose AI interactions, mark synthetic content, and label deep fakes.

The EU Pharma Package introduces a novel approach to combat antimicrobial resistance through transferable exclusivity vouchers that reward innovation in priority antimicrobials while simultaneously implementing stricter antibiotic stewardship measures. This regulatory framework attempts to resolve the fundamental tension between incentivizing pharmaceutical companies to develop new antibiotics and ensuring these critical medicines are used prudently to prevent further resistance development.

Quantum computers capable of breaking widely used public-key cryptography may still be years away, but migration to alternative encryption algorithms expected to be resistant to quantum computers...

The EU Pharmaceutical Package represents the most significant reform of EU pharmaceutical law in over twenty years, but what does it mean for parallel imports of medicines? This analysis examines how the Package affects the regulatory framework for parallel trade, from repackaging requirements to shortage management and electronic package leaflets.

The EU Cyber Resilience Act introduces a comprehensive three-tier classification system for connected products sold in the European market, with compliance obligations scaling from self-certification for everyday devices to mandatory third-party assessment for critical infrastructure components.

The European Union's hydrogen market faces a critical juncture as policymakers balance ambitious renewable energy targets with complex regulatory frameworks that have slowed investment. Recent policy signals from Brussels and Vienna indicate a strategic recalibration—the EU Commission has announced a targeted review of RFNBO production criteria while simultaneously launching new funding mechanisms and infrastructure initiatives.

The European Union has fundamentally transformed packaging regulation with the adoption of the Packaging and Packaging Waste Regulation (PPWR), replacing the existing Packaging Directive...

The EU Pharma Package introduces significant reforms to regulatory data and market protection periods for medicinal products, fundamentally altering the current "8+2(+1)" protection formula.