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European Union Regulatory Authority

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Goodwin

European Biosimilar Updates - Alvotech/Advanz’s MYNZEPLI Approval and Bio-Thera/STADA Tocilizumab Alliance

Goodwin on

On August 21, 2025, Alvotech and Advanz Pharma Holdco Limited (“Advanz”) announced that MYNZEPLI®, a biosimilar of Regeneron’s EYLEA® (aflibercept), was approved by the European Commission. ...more

White & Case LLP

German Federal Court of Justice Upholds Building Cost Subsidies for Battery Storage Operators

White & Case LLP on

The German Federal Court of Justice (Bundesgerichtshof; "BGH") recently ruled that operators of battery energy storage systems ("BESS") must pay building cost subsidies (Baukostenzuschüsse) in the same way as other grid...more

A&O Shearman

SRB Finalises Operational Guidance for Banks on Resolvability Self-assessment

A&O Shearman on

The Single Resolution Board (SRB) published its Operational Guidance for Banks on Resolvability Self-Assessment, accompanied by a press release. This marks a shift towards a more structured and standardised approach for banks...more

Goodwin

Antitrust Life Sciences Quarterly Update 2025 Q2

Goodwin on

The first half of 2025 has seen an acceleration of M&A activity, including large-scale life sciences transactions, such as Merck’s $3.9 billion acquisition of SpringWorks, Sanofi’s $9.5 billion acquisition of Blueprint...more

Hogan Lovells

Facing AMLA Investigations: Key insights for organizations

Hogan Lovells on

The establishment of the European Anti-Money Laundering Authority (“AMLA”) represents a decisive development in the EU's regulatory framework. AMLA aims to unify and strengthen anti-money laundering (“AML”) and...more

White & Case LLP

The Long and Winding Road: Two Decades of Antitrust Enforcement in Spain

White & Case LLP on

"Competition forces you to evolve. When everything is easy, you don't improve". ― Rafael Nadal Parera, 1st Marquis of Llevant de Mallorca Introduction - Over the past two decades, Spain's competition enforcement journey...more

Jones Day

Direct Supervisory Powers of the New European Anti-Money Laundering Authority

Jones Day on

The European Union Anti-Money Laundering ("AML") package includes Regulation (EU) 2024/1620 of the European Parliament and of the Council of May 31, 2024, establishing the Authority for Anti-Money Laundering and Countering...more

Baker Botts L.L.P.

Referrals under Article 22 EUMR — Levels of information required to kick off the statutory deadline for referral by an NCA

Baker Botts L.L.P. on

On 2 July 2025, the Court of Justice of the European Union (General Court) clarified that simply "informing" the authorities of a proposed concentration isn’t enough to kick off the 15-working-days time limit under which a...more

DLA Piper

Belgian VAT Authorities Publish New Circular Letter Regarding Late Input VAT Recovery

DLA Piper on

Seven years after relevant judgments from the CJEU, the Belgian VAT authorities now (broadly) allow the recovery of input VAT beyond the standard Belgian limitation period of three years, subject however to strict conditions....more

BakerHostetler

DSIR Deeper Dive: Artificial Intelligence - Banner Years (and Counting) for AI Guidance and Regulation

BakerHostetler on

The period of 2024-2025 was significant for AI law, regulation, and guidance, beginning in early February 2024, and the news told the tale...more

McDermott Will & Schulte

Federal Court of Justice Rules on Costumer Installation

On May 13, 2025, the Federal Court of Justice (BGH) issued a long-awaited decision (EnVR 83/20) on the question of whether an energy grid can be classified as an unregulated “customer installation” (Kundenanlage). In the...more

Jones Day

New European Anti-Money Laundering Authority Will Have Broad Normative Powers

Jones Day on

The European Union ("EU") Anti-Money Laundering ("AML") package adopted by the European Parliament and the Council on May 31, 2024, represents a major shift in the fight against money laundering and terrorist financing at the...more

Orrick, Herrington & Sutcliffe LLP

EU Commission Clarifies Definition of AI Systems

The European Commission published guidelines that clarify the definition of AI systems under the AI Act, analyzing each component of the definition of AI system, providing examples and specifying which systems should be...more

Baker Botts L.L.P.

Right to Erasure in the Spotlight as EU Data Protection Board Launches 2025 Coordinated Action

Baker Botts L.L.P. on

The European Data Protection Board (EDPB), the independent EU body responsible for ensuring the consistent application of the EU General Data Protection Regulation (GDPR) across all EU member states, has kicked off its...more

Hogan Lovells

Streamlined BCR approval: Understanding the EDPB's updated procedure

Hogan Lovells on

On 19 March 2025, the European Data Protection Board published an updated procedure for co-operation between EU data protection supervisory authorities approving GDPR Binding Corporate Rules for intra-group transfers of EU...more

A&O Shearman

Surge in dawn raid activity signals stricter antitrust scrutiny

A&O Shearman on

2024 saw a continued trend of heightened dawn raid activity by antitrust authorities across the globe. Of the 31 jurisdictions surveyed, 24 (77%) confirmed that the regulator had carried out dawn raids during the course of...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Standard Formula: Encyclopaedia of Prudential Solvency – Chapter 1: The IAIS and the ICS

Established in 1994, the International Association of Insurance Supervisors (IAIS) is a voluntary membership organisation comprising insurance regulatory authorities, central banks, ministries of finance, and other...more

Bergeson & Campbell, P.C.

ECHA Updates Annual Evaluation Statistics and Recommendations to Registrants on Improving Dossiers

The European Chemicals Agency (ECHA) announced on February 26, 2025, that it has updated its annual statistics on evaluation progress. According to ECHA, between 2009 and 2024, it checked the compliance of 15,500...more

A&O Shearman

Antitrust in focus - February 2025

A&O Shearman on

Now out: our latest global trends in merger control enforcement report - In this tenth edition of our annual report, we analyze data for 2024 from 26 jurisdictions to reveal the latest trends in global merger control and...more

Wilson Sonsini Goodrich & Rosati

Upcoming Reporting Obligations Under the EU Digital Services Act

Services subject to the EU’s Digital Services Act (DSA) will be required to publish their annual transparency report by February 16, 2025. This includes providers of hosting services, online platforms, very large online...more

K&L Gates LLP

CJEU Upholds EDPB's Authority to Order Broader Investigations in Cross-Border Cases

K&L Gates LLP on

In a landmark judgment delivered on 29 January 2025, the General Court of the European Union has affirmed the European Data Protection Board‘s (EDPB) authority to require national supervisory authorities to broaden their...more

Hogan Lovells

France is ready to launch DSA enforcement in 2025

Hogan Lovells on

France is taking significant steps towards implementing the Digital Services Act (DSA), with new decrees laying the foundation for its national enforcement. On 3 January 2025, the French Competition and Consumer Authority...more

Benesch

European Union Artificial Intelligence Act: An Overview - January 2025 Update

Benesch on

World’s first comprehensive regulation: The European Union Artificial Intelligence Act (“EU AI Act”) entered into force on August 1, 2024....more

WilmerHale

Standardization for Compliance in the European Union’s AI Act

WilmerHale on

This blog post discusses harmonized standards, common specifications, and certificates in the EU’s Artificial Intelligence Act (“AI Act”). We also discuss the role of the authorities responsible for appointing conformity...more

A&O Shearman

European Supervisory Authorities Publish Joint Guidelines on System for Exchange of Information Relevant to Fit and Proper...

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The European Supervisory Authorities (the European Securities and Markets Authority, European Banking Authority, and European Insurance and Occupational Pensions Authority) published joint guidelines on the system for the...more

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