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European Union › International Harmonization

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 -
WilmerHale

WilmerHale’s Guide to the EU Data Act - September 2024

WilmerHale on

Exactly one year from now, on September 12, 2025, the EU Data Act will enter into application. This new regulation provides harmonized rules on data access, switching cloud providers, and interoperability requirements across...more

Goodwin

EU AI Act: Key Points for Financial Services Businesses

Goodwin on

The European Union (EU) Artificial Intelligence Act (AI Act), Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending...more

WilmerHale

What Are High-Risk AI Systems Within the Meaning of the EU’s AI Act, and What Requirements Apply to Them?

WilmerHale on

In this blog post, we will focus on the identification of “high-risk AI systems” under the Artificial Intelligence Act (“AI Act”) and the requirements applying to such systems. As explained in our previous blog posts, the AI...more

White & Case LLP

Practical and legal implications in France following the EU harmonization of enforcement and penalties for sanctions violations

White & Case LLP on

On 24 April 2024, the EU adopted a new directive (Directive (EU) 2024/1226 of the European Parliament and of the Council) which establishes EU-wide rules for defining criminal offences and penalties related to the violation...more

Latham & Watkins LLP

Proposal to Revise EU FDI Screening Regulation - Revolution or Gradual Evolution?

Latham & Watkins LLP on

The proposed revision is ambitious in scope and aims for a greater harmonization of national FDI regimes. On January 24, 2024, the European Commission (EC) adopted five initiatives to strengthen the EU’s economic...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

WilmerHale

The EU Data Act: A new European legal framework with rules for data access, switching cloud providers and interoperability

WilmerHale on

On 22 December 2023, the EU published Regulation (EU) 2023/2854, the Data Act, in the Official Journal of the EU. The Data Act is a new regulation providing harmonised rules on access to data, switching cloud providers and...more

Goodwin

UK’s Medicines Regulator Announces Guidance on the New International Recognition Procedure for the Approval of New Medicines from...

Goodwin on

Earlier this year, the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), announced that a new International Recognition Procedure (IRP) will be put in place for the approval of new...more

Benesch

UK and AI: The United Kingdom’s Approach to Artificial Intelligence Regulation

Benesch on

On the heels of the United Kingdom (UK) announcing its first global summit on artificial intelligence (AI) safety, British Prime Minister Rishi Sunak predicted that London could be the future epicenter of AI regulation. The...more

WilmerHale

European Parliament Adopts Negotiating Position on the AI Act

WilmerHale on

On June 14, 2023, the European Parliament adopted its negotiating position regarding the proposal of the European Commission for a regulation laying down harmonized rules on artificial intelligence. This is the most recent...more

Akin Gump Strauss Hauer & Feld LLP

The EU IP Harmonization Package to Include EU-wide compulsory License

Akin Gump Strauss Hauer & Feld LLP on

Key Points - The EU aims to harmonize patent protection rules and flexibilities with a layer on top of national rules. This is in line with long-term efforts by the EU institutions to harmonize patent rules and motivated,...more

Latham & Watkins LLP

European Data Protection Board Focuses Coordinated Enforcement on Data Protection Officers

Latham & Watkins LLP on

Organisations should expect increased scrutiny and enforcement activity around the role of data protection officers in the coming year. The European Data Protection Board (EDPB) has announced that its coordinated...more

Jones Day

JONES DAY PRESENTS®: Harmonizing Global Protections: The EU Trade Secret Directive

Jones Day on

A 2018 European Union Directive provided additional protections to trade secrets and harmonized laws between EU member states. Jones Day Madrid Partner-in-Charge Marta Delgado Echevarría and London Partner Rebecca Swindells...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

WilmerHale

A First Look at the European Commission’s Proposal for a Draft Data Act

WilmerHale on

The European Commission has presented its draft Data Act, which will affect a broad range of companies and heavily emphasizes data accessibility and fairness. Companies should begin to evaluate their current practices and...more

Alston & Bird

Major Overhaul of EU Clinical Trial Rules Kicks In on 31 January 2022

Alston & Bird on

On 31 January 2022, the EU Clinical Trial Regulation (CTR) will come into application, almost 8 years after its adoption by the European Parliament and the Council of the EU. The CTR will radically change the regulatory...more

Hogan Lovells

European Commission publishes harmonised standards in support of the MDR and IVDR

Hogan Lovells on

The European Commission adopted Implementing Decisions (EU) 2022/6 of 4 January 2022 and 2022/15 of 6 January 2022 regarding harmonised standards in support of Regulation (EU) 2017/745 (the "Medical Devices Regulation" -...more

BCLP

AIFMD II: An evolution not a revolution at round 1

BCLP on

Today (25 November 2021) the European Commission (the Commission) released the results of its evaluation of the Alternative Investment Fund Managers Directive (AIFMD) which forms part of a Capital Markets Union legislative...more

Eversheds Sutherland (US) LLP

EU-US Insurance Dialogue Project takes up new technologies and cyber threats that have no borders; Regulatory collaboration in a...

Eversheds Sutherland (US) LLP on

The EU-US Insurance Dialogue Project (“Project”) began in early 2012 as an initiative by the European Commission, the European Insurance and Occupational Pensions Authority (EIOPA), the Federal Insurance Office (FIO) of the...more

Latham & Watkins LLP

UK Chancellor Outlines Future for Financial Services Post-Brexit

Latham & Watkins LLP on

Equivalence decisions for EEA states, green finance and fintech initiatives are at the forefront of the UK government’s priorities. On 9 November 2020, the UK Chancellor of the Exchequer, Rishi Sunak, delivered a statement...more

Barnea Jaffa Lande & Co.

Crowdfunding Platforms – New Regulation in Europe

Barnea Jaffa Lande & Co. on

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

White & Case LLP

GDPR Guide to National Implementation: Malta - A practical guide to national GDPR compliance requirements across the EEA

White & Case LLP on

Q1/ Applicable legislation - (a) Have the requirements of the GDPR been addressed by introducing a new law, or by updating existing legislation? New legislation has been passed....more

White & Case LLP

GDPR Guide to National Implementation: Netherlands - A practical guide to national GDPR compliance requirements across the EEA

White & Case LLP on

Q1/ Applicable legislation - (a) Have the requirements of the GDPR been addressed by introducing a new law, or by updating existing legislation? New legislation has been passed....more

White & Case LLP

GDPR Guide to National Implementation: Norway - A practical guide to national GDPR compliance requirements across the EEA

White & Case LLP on

Q1/ Applicable legislation - (a) Have the requirements of the GDPR been addressed by introducing a new law, or by updating existing legislation? New legislation has been passed....more

White & Case LLP

GDPR Guide to National Implementation: Poland - A practical guide to national GDPR compliance requirements across the EEA

White & Case LLP on

Q1/ Applicable legislation - (a) Have the requirements of the GDPR been addressed by introducing a new law, or by updating existing legislation? New legislation has been passed replacing the main pre-GDPR legislation...more

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