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On 19 July 2024, the European Commission (the "Commission") adopted a delegated regulation and accompanying annexes containing its regulatory technical standards ("RTS") supplementing Regulation EU 2015/760, as amended by...more
Today marks a significant milestone in the regulation of artificial intelligence (AI) as the European Union (EU) AI Act is published in the EU Official Journal. This landmark legislation establishes the world’s first...more
On May 21, 2024, the European Union finalized the adoption of the groundbreaking EU Artificial Intelligence Act, a comprehensive and sector-agnostic legislation that extends globally. This 420-page Act aims to regulate the...more
The European Parliament formally adopted the EU Artificial Intelligence Act (AI Act), a first-of-its-kind comprehensive regulation governing the use of artificial intelligence (AI), on March 13, 2024. While applicable to a...more
European Securities Market Authority (ESMA) submitted draft ELTIF 2.0 Regulatory Technical Standards (RTS) to the European Commission in December 2023. European Commission has informed ESMA it will only adopt the RTS once...more
The European Union Digital Services Act (DSA) now applies to all digital “intermediary services” that provide users with access to online goods, services, and content. The DSA took effect on November 16, 2022, and regulates a...more
The European Commission (EC) is in the process of implementing its “Union database” (UDB) to track all renewable gases and liquid fuels. Gases and fuels, whether produced in the EU or imported, will need to be registered in...more
Here are some of our key focus items across Europe and the UK as we enter a New Year. There are, of course, others, but these represent the most important themes – a regulatory focus on the non-bank credit market, risk...more
For in scope companies, disclosures may be required as early as the reporting period for the 2024 financial year. On 22 December 2023, the Commission Delegated Regulation specifying the first set of European...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
It has been some time already since the EU Digital Services Act (Regulation 2022/2065, DSA) was published, and since then, the discussions about Very Large Online Platforms (VLOPs) and Very Large Online Search Engines...more
On December 8, 2023, EU policymakers reached an agreement on the Artificial Intelligence Act (AI Act). As a standard-bearer for global digital and data governance, the EU has been setting regulatory benchmarks on emerging...more
The Council of the European Union and the European Parliament reached a provisional agreement on a new comprehensive regulation governing AI, known as the “AI Act,” late on Friday night (December 8, 2023). While the final...more
On July 31, the European Commission adopted the first set of rules under the European Sustainability Reporting Standards (ESRS). The ESRS is an important follow-up to the adoption of the Corporate Sustainability Reporting...more
This Summer, the European Commission asked for comments on the proposed regulations that are wending their way through the European Parliament (see, e.g.), and I (here for mine) and some 150 other individual and entities...more
Midnight on July 3, 2023, heralded the deadline for potential gatekeepers to notify the European Commission (EC) as to whether they meet the thresholds for gatekeepers set out in Article 3 of the Digital Markets Act (DMA)....more
We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more
On 26 April 2023, the European Commission published two legislative proposals - a new Regulation 2023/0131 and a new Directive 2023/0132 - to replace the current EU regulatory framework for all medicines (including those for...more
Impact on public procurement procedures. The EU Foreign Subsidies Regulation (FSR) was published on 23 December 2022. It will take effect on 12 July 2023 and provides for mandatory notification requirements from 12...more
The Digital Services Act (DSA) is a key part of the European Union’s (EU) digital regulation strategy, which seeks to modernise legal frameworks and create a safer and more open digital environment. The DSA entered into...more
The Plan aims to “simplify, accelerate and align incentives to preserve the competitiveness and attractiveness of the EU as an investment location for the net-zero industry”. On 1 February 2023, the European Commission...more
La Ley de Servicios Digitales de la Unión Europea es un reglamento europeo (aprobado hace pocos meses) que regula el ecosistema de las plataformas de intermediación de internet. Será de aplicación de manera escalonada en el...more
In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will significantly impact...more
Having been approved by a vote of the Council of Ministers, the EU’s Digital Services Act (DSA) was published in the Official Journal of the European Union on October 13, 2022 and is expected to come into force in November. ...more