News & Analysis as of October 19, 2024

Regulatory Requirements

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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 -

EU’s AI Act – Coming to an AI Near You

Bass, Berry & Sims PLC on 8/6/2024

On August 1, the European Union’s Artificial Intelligence Act (Act) entered into force. This groundbreaking legislation is set to be implemented in stages over the coming years and is expected to have a profound impact on the...more

Spotlight on political laws - Brief overview of recent developments and upcoming changes in Germany

A&O Shearman on 6/10/2024

The regulatory environment for influencing and funding political players in Germany has been changing rapidly in recent months. On 1 March 2024, the revised Federal Lobbying Register Act (Lobbyregistergesetz; LobbyRG),...more

[Webinar] Regulation Refresh on Global Supply Chain Exposure - February 28th, 9:00 am - 10:00 am PT

NAVEX on 2/19/2024

The past two years brought heightened scrutiny to supply chain risks and human rights violations, and time is running out to ensure your organization is compliant with the recent regulation updates and policy requirements. ...more

Draft EuGB Regulation and implications for future green ABS

White & Case LLP on 9/26/2023

On 10 May 2023, the Council of the European Union (the "Council") submitted a draft for a European Green Bonds Regulation (the "Draft EuGB Regulation") to the European Parliament for review and approval....more

Fünf wichtige Hinweise zum Transparenzregister – Unternehmen müssen aktiv werden

Spirit Legal on 4/22/2022

Seit dem 01. August 2021 gibt es neue Pflichten für Unternehmen im Zusammenhang mit dem Transparenzregister. Das hat für viele Unternehmen zur Folge, dass eine bislang entbehrliche Eintragung der wirtschaftlichen Berechtigten...more

Aufsichtsrechtliche und zivilrechtliche Rechtsfolgen bei Verstößen gegen Transparenzpflichten nach der OffenlegungsVO und...

King & Spalding on 6/10/2021

Seit dem 10. März dieses Jahres gilt die Verordnung (EU) 2019/2088 des Europäischen Parlaments und des Rates vom 27. November 2019 über nachhaltigkeitsbezogene Offenlegungspflichten im Finanzdienstleistungssektor...more

Europe Seeks to Tame Artificial Intelligence with the World’s First Comprehensive Regulation

Perkins Coie on 4/29/2021

In what could be a harbinger of the future regulation of artificial intelligence (AI) in the United States, the European Commission published its recent proposal for regulation of AI systems. The proposal is part of the...more

The Share Trading Obligations – A New Year’s Mess

BCLP on 12/23/2020

Diverging approaches to Share Trading Obligations from the FCA and ESMA pose challenges for investment firms in a post-Brexit Europe. With 1 January 2021 creeping closer and the hope of securing an effective Brexit deal...more

European Chemicals Agency SCIP Database is launched and ready for use

BCLP on 12/3/2020

At the end of October, the European Chemicals Agency (ECHA) launched the SCIP database. When populated, the database will ensure that information on articles in the EU that contain substances of very high concern (SVHCs) is...more

The Belgian Data Protection Authority Publishes Recommendation Concerning Data Processing for Direct Marketing Purposes

Hogan Lovells on 3/6/2020

On January 17, The Belgian Data Protection Authority (DPA) published Recommendation no 01/2020 providing Guidance on direct marketing. The Recommendation provides a methodology on how to comply with the General Data...more

Newsflash: Resolution demanding better traceability of food products in Germany

Hogan Lovells on 2/26/2020

Once again there is a new attempt in Germany to introduce stricter requirements for food safety – despite the full harmonization approach in general EU food law...more

Tech Tax – Looking Forward to 2020

Hogan Lovells on 2/6/2020

Following-up from our previous blogs on Tech Tax, we thought it would be useful to take a whirlwind tour of what to expect in tax and transfer pricing related topics in 2020. But for those that are curious, why are such...more

European Commission provides clarification regarding the implementation of the Clinical Trials Regulation

Hogan Lovells on 11/18/2019

The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the implementation of the rules governing...more

ADG Insights | Foreign investment control in the European Union and its Member States

Hogan Lovells on 8/2/2019

In recent years, several European Union (EU) Member States, as well as the EU itself, have reconsidered their approaches to foreign direct investment (FDI). An increasing number of European jurisdictions have introduced rules...more

Financial Regulatory Observer – June 2019: No-deal Brexit: Challenges for trading venues and their participants

White & Case LLP on 7/1/2019

There is no silver bullet for maintaining cross-border trading if the UK leaves the EU without a deal. The date of Brexit has been delayed until (at least) October 31, 2019, but there is little sign that financial...more

ESMA’s Final Draft Disclosure Technical Standards

Cadwalader, Wickersham & Taft LLP on 8/29/2018

On 22 August 2018, the European Securities and Markets Authority (“ESMA”) published its Final Report on the technical standards on disclosure requirements under the EU Securitisation Regulation (the “Final Report”)....more

The Proposed SPC Export Manufacturing Waiver: Really a Balanced Approach?

Jones Day on 6/18/2018

The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

Hogan Lovells on 6/12/2018

On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more

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