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New Regulations Member State European Union

McDermott Will & Emery

Illumina/GRAIL: European Court of Justice Annuls the Commission’s Approach

In a spectacular turn, on September 3, 2024, the Court of Justice (CJEU), constituted as the grand chamber, overturned the ruling of the General Court (GC) and annulled the decision made by the Commission to accept requests...more

BCLP

The European Union Against Deforestation: the Companies Concerned Still Have 8 Months to Take Action

BCLP on

On December 30, 2024, the European regulation of May 31, 2023 on deforestation will come into force in all EU countries. The aim of these new rules, which are designed to combat the phenomenon of imported deforestation, is to...more

Barnea Jaffa Lande & Co.

European AI Act Approved by the European Parliament

On March 13, 2024, the European Parliament approved the AI Act regulating the use of artificial intelligence in the Union. This is groundbreaking legislation and the first of its kind in the world, aimed at creating effective...more

White & Case LLP

European Commission proposes measures to up the ante on EU FDI screening

White & Case LLP on

Foreign direct investment ("FDI") screening was one of the major topics of 2023 as a myriad of new regimes joined the FDI club and its more seasoned members continue to strengthen scope and enforcement, with the impacts felt...more

A&O Shearman

Draft EU Foreign Investment Screening Regulation sets out more comprehensive screening regime

A&O Shearman on

On 24 January 2024, the European Commission (EC) published its proposed reform of foreign investment screening in the EU. The proposal introduces more comprehensive rules for the review of foreign investments and strengthens...more

McDermott Will & Emery

New From January 2024 | Participation Exemption for European Corporations on Disposal of Shareholdings

McDermott Will & Emery on

The Italian government recently approved a draft 2024 budget law which provides for the extension of the domestic participation exemption regime on disposal of shareholdings (PEX) to those non-resident corporations that: (i)...more

WilmerHale

EU Foreign Subsidies Regime: Publication of Final Implementing Regulation

WilmerHale on

The EU’s Foreign Subsidies Regulation (FSR) was adopted in late 2022. Its stated aim is to combat the effects of competitive distortions caused by foreign subsidies in the EU internal market and thereby level the playing...more

McDermott Will & Emery

FDI Screening: When Does National Interest Override Investment?

McDermott Will & Emery on

A recent decision from the European Court of Justice (ruling C-106/22) has significant impact on EU foreign investment screening mechanisms....more

Goodwin

Marketing Crypto-Assets in and Into Europe: MiCAR, the EU’s New Uniform Crypto Code

Goodwin on

The EU Markets in Crypto-Assets Regulation (MiCAR) was published in the Official Journal of the European Union on 9 June 2023. MiCAR is a the major, step toward an EU-wide uniform code governing crypto-assets, such as BTC,...more

WilmerHale

Final Adoption of the EU's Foreign Subsidies Regulation

WilmerHale on

On November 28, 2022, the Council of the European Union (Council) gave its final approval to the proposed Regulation on Foreign Subsidies (Regulation), concluding seven months of negotiations with the EU Parliament. Under...more

Latham & Watkins LLP

New Regulation on Health Technology Assessment Seeks to Facilitate EU-Level Joint Clinical Assessments From 2025

Latham & Watkins LLP on

The regulation aims to harmonise clinical and scientific aspects of HTA to make innovative health technologies more widely available in the EU. Health technology assessment (HTA) is a multidisciplinary evidence-based...more

King & Spalding

Europe - Between The EU Clinical Trials Regulation And The UK Guideline On Clinical Trials

King & Spalding on

Last week the Regulation on Clinical Trials (“CTR”) finally became effective in the European Union (“EU”) and replaced the prior Clinical Trials Directive 2001/20 (“CTD”). The CTR was adopted in 2014 and was meant to enter...more

BCLP

Safety net or overreach? The European Commission’s new policy on Member State merger referrals

BCLP on

In 2020, European Competition Commissioner Margrethe Vestager announced a new policy, under which the Commission will entertain requests from Member States to review mergers that do not meet the notification thresholds for...more

White & Case LLP

New Regulation of Cross-border Transactions – Act on Screening of Foreign Investments

White & Case LLP on

On May 1, 2021, the Foreign Direct Investments Screening Act (Act No. 34/2021 Coll. – the "FDI Act") is set to come into force, which will allow the government to screen potentially high-risk foreign transactions by investors...more

Barnea Jaffa Lande & Co.

Crowdfunding Platforms – New Regulation in Europe

The European Parliament recently adopted a new regulation on crowdfunding platform activity. This regulation will apply across the board to all European Union countries. The regulation’s adoption sprang from the desire to...more

Jones Day

The EU "Club" Gets More Exclusive: Closing The Doors On Foreign Subsidies?

Jones Day on

Although the EU has strict rules that limit the circumstances in which Member States can subsidize companies in the EU, the rest of the world does not. The European Commission considers this difference unfair because it would...more

Dechert LLP

The European FDI Regulation: What You Need to Know

Dechert LLP on

The EU Foreign Direct Investment Regulation will be in full force from October 11, 2020. We expect it will radically alter the dynamics of foreign investment review in Europe. Any non-EU investor and any EU target company...more

Katten Muchin Rosenman LLP

New EU-Wide Tax Anti-Avoidance Law Introduces Sweeping Disclosure Requirements

Key Points - Coming into force on 1 July 2020, EU DAC6 Regulations will require intermediaries in certain cross-border arrangements to disclose activity to tax authorities. - The DAC will apply retroactively to affected...more

A&O Shearman

EU Legislative Package for Cross-Border Distribution of Investment Funds Published

A&O Shearman on

A Regulation and a Directive aimed at facilitating the cross-border distribution of investment funds have been published in the Official Journal of the European Union. The Directive amends the Directive on Undertakings for...more

McDermott Will & Emery

European SPC Manufacturing Waiver Goes into Force

McDermott Will & Emery on

Newly issued EU Regulation 2019/933 provides supplementary protection certificate exemptions for exporting and stockpiling active pharmaceutical ingredients and medicinal products if certain anti-abuse requirements are met....more

A&O Shearman

EU Capital Requirements Directive V and Capital Requirements Regulation II Finalized

A&O Shearman on

The legislative amendments to the EU's Capital Requirements Regulation and the Capital Requirements Directive, widely referred to as "CRD5" or "CRR2", have been published in the Official Journal of the European Union. Subject...more

McDermott Will & Emery

Digital Health in the United Kingdom: The New Regulatory Environment Under the Medical Device Regulation

The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU Adopts Regulation on Foreign Direct Investments

On March 19, 2019, the European Union adopted a regulation for the screening of foreign direct investments into the EU (the Regulation). The Regulation sets forth national security factors that EU member states (Member...more

A&O Shearman

EMIR Refit Regulation Published

A&O Shearman on

The Regulation amending the European Market Infrastructure Regulation, known as EMIR Refit or EMIR 2.1, has been published in the Official Journal of the European Union....more

Jones Day

Jones Day Talks: EU's New Foreign Direct Investment Regulations Eye Specific Sectors

Jones Day on

In step with a global trend, the European Union has enacted a framework, effective October 11, 2020, for screening foreign direct investment into EU states. Jones Day's Renato Antonini, Eva Monard, and Chase Kaniecki discuss...more

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