International Harmonization

News & Analysis as of

Brexit – Standards and Innovation: What’s Ahead?

This article is the second in an ongoing series of blog posts by Foley & Lardner LLP on the implications of the June 23, 2016 referendum decision in the United Kingdom (“UK”) to exit the European Union (“EU”). The first blog...more

The Digital Single Market Strategy: One Year On

In May 2015, the European Commission announced its Digital Single Market Strategy to accelerate the creation of a digital single market (DSM) across the EU. The EU’s aim is to broaden access to e-commerce, media and...more

Overlapping Labels Can Lead to Liability

Multiple regulatory agencies worldwide exercise jurisdiction over how hazards associated with chemicals in the workplace are communicated to employees and others. This creates a complex web of requirements and...more

SADC Memorandum of Understanding on Inter-Agency Cooperation in Competition Policy, Law and Enforcement

African countries are moving towards greater cooperation on the enforcement of competition law in cross-border transactions. Member states of the Southern African Development Community have signed a memorandum of...more

Unlocking the EU General Data Protection Regulation: A practical handbook on the EU's new data protection law: Chapter 3: Subject...

Why does this topic matter to organisations? Understanding the subject matter and the scope of EU data protection law is fundamental to determining whether this law applies to an organisation's business activities. In...more

EU Adopts Cybersecurity Directive: What US Companies Need to Know

Not all the news coming out of Europe these days is about Brexit. In fact, the forces of unity and harmonization remain a top priority for European regulators hoping to combat digital security threats and create a safer and...more

Prime Minister Modi’s Visit to the U.S.: U.S., India Seek Stronger Ties, Increased Trade

The world’s largest democracy and the world’s most powerful democracy continue to seek ways to create deeper ties. Given larger geopolitical trends, it appears the relationship is blossoming, which presents opportunities for...more

EU Cybersecurity Directive Brings Notification and Security Requirements for Industry

The first European Union-wide rules on cybersecurity have been adopted by the European Parliament. Approved on July 6, 2016, the Directive on Security of Network and Information Systems (NIS Directive) creates new risk...more

FDA Issues Final Rule on Use of Symbols in Labeling

The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more

Brexit’s Impact on the Biosimilar Market

The United Kingdom’s referendum in favor of withdrawal from the European Union, colloquially known as “Brexit,” has already sent shockwaves through the business world, both within the UK, and abroad. The impact of Brexit on...more

CFTC Proposes to Expand Mandatory Clearing to Include Additional Classes of Interest Rate Swaps

On June 9, the Commodity Futures Trading Commission (CFTC) released a notice of proposed rulemaking regarding an expansion of CFTC Regulation 50.4(a). If adopted, additional classes of interest rate swaps will become subject...more

FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels

This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of...more

International Council on Harmonisation (ICH) Includes International Generic and Biosimilars Trade Organization (IGBA) for the...

On June 15, 2016, the International Council for Harmonisation (ICH) (formerly the International Conference on Harmonisation) announced that the International Generic and Biosimilars Medicines Association (IGBA) could join ICH...more

Brexit and Retail

Britons are due to go to the polls to vote in a referendum on 23rd June 2016 to decide whether the UK should remain a member of the EU, or exit (a so called “Brexit”). As many readers will be aware, there is no certain answer...more

European Commission moves to restrict geoblocking

On 25 May 2016 the European Commission published draft legislation aimed at restricting the use of geoblocking and similar practices by websites selling to into the European Union. The European Commission has published a...more

Employers need to review protection of confidential information as new European laws are approved to harmonise the protection of...

Employers need to be aware that the Trade Secrets Directive (TSD) was approved yesterday by the European Council, marking the end of its legislative journey in Europe. We can now expect to see its swift publication in the...more

The impact on franchising of the new European Directive for the protection of trade secrets

On 14 April 2016, after a lengthy gestation period, the European Parliament finally approved a new European Union Trade Secrets Directive. This will be the basis for new harmonised laws to protect secret and valuable...more

MiFID II: Access to EU Markets for Third Country Investment Firms

This note discusses the MiFID II regime for access by financial institutions located outside the EU to EU customers and markets. Full harmonisation of the access regime for third country firms has not been achieved. Instead...more

European Commission Assesses Progress on Capital Markets Union

The European Commission published a status report on progress made since the adoption of the Capital Markets Union Action Plan. The European Commission's Action Plan, published in September 2015, set out the steps for the...more

MiFID 2: PRA issues consultation paper - This article looks at PRA's plans to change its rules to implement the passporting and...

MiFID 2 implementation timeline - Currently, the MiFID 2 package is still scheduled to take effect on 3 January 2017. Member States are supposed to have finalised necessary changes to domestic laws by 3 July 2016....more

Unifying trademark laws in the GCC - are you prepared?

The GCC member states appear to be moving closer to harmonisation of their trademark laws. This briefing considers the next steps in the process and the implications of the new law for businesses with brand assets in the GCC....more

European Trademark Reform: The 10 most relevant changes for Trademark Portfolio Management

European trademark law is facing the biggest reform since the introduction of the Community trademark system in 1996. The recently adopted European Trademark Reform will bring substantial changes not only to Community...more

EU Data Protection Reform Will Force Big Changes Globally

Earlier this week, on December 15, 2015, EU officials approved the text of new data privacy regulations after nearly four years of discussions. The EU-wide bill, which will supersede what is now known as the EU Data...more

Gesetz zur Umsetzung der Transparenzrichtlinie - Änderungsrichtlinie

Nachdem der Bundestag am 1. Oktober 2015 den Entwurf eines Gesetzes zur Umsetzung der Transparenzrichtlinie-A¨nderungsrichtlinie angenommen hatte (BT-Drucksache 18/6220), hat dieser am 6. November 2015 den Bundesrat passiert....more

IGPA 2015 Focuses on Biosimilars, Quality, and Harmonization in Toronto-Part Two of Two

The following day features a panel of chief executive officers from a variety of pharmaceutical companies of different sizes and focus areas. Common themes included ongoing industry consolidation and increasing concern about...more

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