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Welcome to the Regulation Round Up, a regular bulletin highlighting the latest developments in UK and EU financial services regulation....more
The European Union Batteries Regulation 2023/1542 started applying in August 2024 and represents a major change for anyone who manufactures, imports, or sells stand-alone batteries, or products containing batteries....more
The ESAs urge the European Commission to consider a labelling rather than a disclosure regime to help consumers understand the sustainability goals of financial products....more
Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom. On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published...more
The year 2024 holds the potential for significant developments in the World Trade Organization (WTO) dispute settlement mechanism. With the upcoming 13th Ministerial Conference (MC13) in February, members may reach agreements...more
On February 14, 2023, the European Commission (EC) appealed the November 23, 2022, decision of the European General Court that annuls the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic...more
The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more
On November 17, 2022, the Court of Justice of the European Union (CJEU) found in its latest principal judgment (Novartis v. Abacus, case file C-147/20) that the reboxing of parallel imported medicines in the European Union...more
Our recent briefing note explained that CE product safety marking, which is required to sell certain types of goods in the European Union, was being replaced by the UKCA mark in Great Britain (GB) following Brexit. The...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
Takeaway: Security labels on internet-connected devices are on the horizon for companies that manufacture and want to sell such devices worldwide. On October 19, 2022, 50 representatives from different industries including...more
On August 22, 2021, the French Parliament adopted the Climate and Resilience Law ("2021 Climate Law"). In aiming to accelerate the transition to a carbon-neutral and more resilient society, the 2021 Climate Law imposes...more
On 10 April 2020, the European Commission, the EMA and the European medicines regulatory network published a notice providing guidance to stakeholders regarding regulatory expectations for medicinal products for human use...more
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
When structuring and assessing transactions in the food and beverage sector in a European context, a purchaser must consider and evaluate several EU-specific requirements in order to ensure a successful transaction with...more
On October 12, 2018, the EC announced new requirements for labeling fuel. As of the aforementioned date, European Union (EU) Member States must use set fuel labels on newly produced vehicles, at vehicle dealerships, and at...more
Hogan Lovells Total Brand Care is our firmwide holistic approach to creating, commercializing and protecting our clients’ most valuable asset – their brands. Creative product labeling and packaging can help promote and add...more
From bright and glossy, to refined and elegant, product labeling and packaging convey information, messaging, and claims about a brand. At the same time the labeling and packaging must also include mandatory information,...more
On March 13, the European Commission approved a report that calls on members of the alcohol beverage industry to develop a comprehensive self-regulatory system of ingredient and nutritional labeling for beer, wine, and...more
On May 12, 2016, the European Parliament renewed its call for mandatory country-of-origin labeling (“COOL”) for meat and dairy products not currently subject to such marking rules. The reasoning behind requiring additional...more
In This Issue: - Are Offers Of Free Credit Monitoring About To Become Mandatory In Data Breach Incidents? - Mandatory “Made-In” Labeling in the EU - A New Dawn for California Class Actions - Recent...more
Within the next 12-18 months, companies are facing multiple deadlines for various country adaptations of the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). These include...more
On May 19, 2014, the European Commission (EC) Joint Research Center (JRC) announced the availability of a report discussing labeling and reporting schemes for nanomaterials in consumer products in the European Union (EU). The...more