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Focus on Regulation

Tag Archives: EU

What you need to know before Brexit gets underway this week

The Brexit process gets officially underway this week when the UK formally notifies the European Council of its intention to withdraw from the EU on 29 March 2017.  The road ahead is untested and uncertain, as the UK will be the first EU Member State ever to leave the Union. Hogan Lovells will be hosting

U.S. FDA and EU Regulators Announce Enhanced Mutual Recognition for Pharmaceutical Manufacturing Inspections; Allows FDA to Continue Shifting Inspections and Enforcement Focus to Asia

In an effort to avoid the duplication of drug inspections, lower inspection costs, and enable regulators to devote more resources to other parts of the world where there may be greater risk, the U.S. Food and Drug Administration (FDA) and the European Union (EU) today announced that they have enhanced their agreement on mutual recognition

Medical Device Alert – Finalised texts of the new EU Regulations on medical devices and in-vitro diagnostic medical devices are out

On 22 February 2017, the Council of the European Union issued the final versions of the draft texts of the European Union (“EU”) Medical Device Regulations (“MDR”) and the In Vitro Diagnostics Regulation (“IVDR”). The finalised versions of the draft texts are available here and here. Final Adoption of the texts anticipated in March The

Brexit: a play in four acts?

The stage is set for the Euro-drama of our time. We know that giving effect to the UK’s vote for Brexit could require as many as four sets of distinct but closely linked negotiations, or “acts”, dealing with the terms of: the UK’s withdrawal from the EU; the UK’s future relationship with the EU after

This is the house that Brexit built

The new May Government has now been fully established and has begun getting to work. Judging by last week’s notable developments, foreign affairs is top of the agenda. Brexit diplomacy: Good cop, bad cop? The Prime Minister made her first official visits to Germany and France last week to meet Angela Merkel and François Hollande.

Another week of Brexit developments: 5 – 11 July 2016

Following on from last week’s comments from Donald Tusk and Jean-Claude Juncker about when the EU expects the UK to trigger Article 50 of the Treaty on the European Union, comments by British officials in the last week have shed further light on the road to Brexit ahead. What are the UK’s “constitutional requirements” for

Brexit and human rights – does Theresa May have a point?

One of the surprises in Theresa May’s comments yesterday was the distinction she drew between the European Union and the European Convention on Human Rights – making clear that, in her view, it was the latter that was the greater cause for concern in the sphere of national security. All too often, no such distinction

EUDRAVIGILANCE ACCESS POLICY REVISION

On the 12 January 2016, the European Medicines Agency (“EMA”) published an overview of comments in response to a public consultation regarding a “Draft revision of EudraVigilance access policy for medicines for human use”

India’s New BIT and Arbitration Law Send Mixed Signals to Foreign Investors

On December 28, 2015, the Government of India released the text for its revised model Bilateral Investment Treaty (BIT). In this release, the Government of India also announced that the Department of Economic Affairs will be leading all negotiations on BITs and investment chapters of trade agreements to ensure continuity between trade and investment issues.

Belgian endives on the frontline for price fixing by farmers

Belgian endives are a divisive vegetable: their bitterness delights some but repulses others. And even amongst Belgian endive enthusiast you’ll find some that prefer them raw – to maintain their crispness – while others like them cooked so that their bitterness comes out even more. But Belgian endives are no longer the exclusive battleground of

Potential Impact of the Draft EU Data Protection Regulation on the Life Sciences Sector

On 15 June 2015, the Council of the European Union (“Council”) adopted its position on the draft Proposal for a Regulation of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (“Draft Regulation”). This article discusses

European Commission Action Plan on Antimicrobial Resistance

On 26 February 2015, the European Commission published a progress report concerning the Commission’s five year Action Plan on Antimicrobial Resistance (“Action Plan”). The purpose of the progress report is to inform the European Parliament, the EU Member States and other stakeholders about progress to date in relation to the implementation of the Action Plan.

European Commission publishes minimum principles for shale gas exploration

On 22 January 2014, the European Commission (Commission) published a “Recommendation on minimum principles for the exploration and production of hydrocarbons (such as shale gas) using high volume hydraulic fracturing” (Recommendation). The Recommendation sets out minimum core principles for the exploration and production of hydrocarbons (e.g., shale gas) using high-volume hydraulic fracturing. The Recommendation is

Limited easing of certain Iran sanctions

On 20 January 2014, as part of the Joint Plan of Action, the U.S. and EU have implemented “limited, targeted, temporary and reversible” relief from certain sanctions measures in return for Iran’s agreement to commence the winding down of certain aspects of its nuclear program. This limited easing is valid for a six-month period only,

EU Continues Move toward Stricter Network Neutrality Obligations

If new European Union proposals are implemented, European broadband providers may need to comply with expansive network neutrality obligations that are both similar to and different from earlier Federal Communications Commission (FCC) rules. Citing the need for harmonized regulation, European regulators have taken a number of steps this fall toward strengthening Open Internet protections.

The Global Antitrust Corner – Latest Developments in U.S. and EU Cartel Damages Claims

On 9 December, we are hosting a 60-minute webcast featuring Hogan Lovells lawyers from London, Munich, and Washington, D.C. who will address recent developments for businesses facing or contemplating potential antitrust damages claims in the United States and Europe, including the United Kingdom and Germany, as major jurisdictions for cartel damages claims. This is the fifth program in

Can US Attorneys Provide Privileged Advice In Europe?

The United States exported an all-time record high of $2.2 trillion worth of goods and services in 2012.  But while U.S. business has gone global, the attorney-client privilege has not always come along for the ride. In 2010, the European Court of Justice (ECJ) in Akzo Nobel Chemical Ltd. and Akcros Chemical Ltd. v. European

Shale gas exploration: European Commission launches stakeholder Consultation

The European Commission is completing a Consultation on the need for additional regulation of unconventional fossil fuel (e.g., shale gas) exploration and development in Europe. The Consultation period ends on 23 March 2013 and results will be made available on the Commission’s website and at a stakeholders’ meeting to be held by the Commission in