Chapter 8: Technical Barriers to Trade This chapter provides rules to facilitate trade by eliminating unnecessary technical barriers, improving transparency, and promoting greater regulatory cooperation. It applies to the elaboration, approval and application of technical regulations, standards, conformity assessment procedures and trade authorization for pharmaceuticals, cosmetics and medical devices ...
After a long pause, we are pleased to release a new version of our regulatory Guides. To cover the gap since the last publication, we would like to devote this Guide to an overview of key changes and trends that took place in 2022. 2022 was a challenging year for many companies working on the Russian market as well as for the Russian market and economy as a whole ...
Dear Readers, ALRUD Regulatory practice has prepared a new version of our regulatory Guides. This Guide is devoted to an overview of key changes and trends that took place in 2022. The review was published with the participation of ALRUD experts - Maxim Alekseev, Senior Partner and Head of ALRUD Regulatory practice,Dina Kravchenko, Senior Associate, andBoris Pribylov, Senior Associate. Follow the link below to learn more ...
Published in Corporate Counsel Business Journal March 1, 2023 CCBJ: To start out, please share your background with our readers, including your involvement with the WSG–Legal 500 Survey of In-House Legal Technology. Herman Raspé: I am a partner at Patterson Belknap Webb & Tyler in the capital markets group with a focus principally on equity, but also cross-border debt transactions ...
This is the third alert in a series designed to inform physicians and other health care providers of what to do in the event of a State Medical Board of Ohio (“Board”) investigation, how to potentially avoid an investigation and what to expect during a license disciplinary case ...
On the 28th of February 2023, the European Data Protection Board (hereinafter referred to as the “EDPB”) issued its Opinion on the European Commission’s draft adequacy decision regarding the EU-U.S. Data Privacy Framework ...
Cisco has recently released its 2023 Privacy Benchmark Study which explores the impact of data privacy on organisations around the world and why data protection compliance remains mission critical for businesses. The study finds that 95% of companies understand privacy to be a ‘business imperative’, but Harvey Jang, Cisco’s privacy chief, highlights that ‘when it comes to earning and building trust, compliance is not enough’ ...
In the ‘Proposal for a Regulation laying down harmonised rules on artificial intelligence’ (the “draft EU AI Act”), transparency is regulated by Article 13 and Article 52 thereof. The former applies to systems of Artificial Intelligence (“AI”) which are classified as high-risk and the latter applies to limited-risk AI systems ...
Blockchain litigation lead, Matt Green will be hosting our latest podcast series, 'In Early - The Crypto Podcast' - Listen to episode 8. This week is about Bitcoin and the Tulip Trading case (recently in the Court of Appeal), in which a claimant seeks to transfer his Bitcoin without a private key, looking for the blockchain’s software developers to transfer them for him ...
Illinois has the strictest biometric privacy law in the country with the Biometric Information Privacy Act (“BIPA”). The BIPA requires employers who collect employees’ biometric data to follow a number of protocols. These protocols include (1) maintaining a written policy about the collection and storage of employee biometric data, (2) providing employees with written notice of that policy, and (3) obtaining informed consent from employees to collect biometric data ...
Nearly 106,000 Americans are currently on waiting lists for donor organs and 17 die each day while waiting. The holy grail for rising to meet this demand and end this suffering will be the ability to “print” the organs, muscles, and tissues from individually grown cells, lowering the need for human donors and the complicated and sometimes unbearable stress that goes along with donor wait lines ...
The Virtual Assets Regulatory Authority (VARA) is a regulatory body established by the government of Dubai to oversee and regulate the virtual assets industry. In line with its mandate, VARA has issued a number of rule books, in particular the Compliance and Risk Management Rulebook (CRM), which sets out the regulatory framework for virtual asset service providers (VASPs) operating in Dubai ...
On February 20 of this year, the Public Health Institute (hereinafter "ISP"), approved through Exempt Resolution No. 401/23 the technical guide for the sanitary registration of allergens with the purpose of establishing the guidelines and requirements for the sanitary registration of these products (the "Guide") ...
On February 20 of this year, the Public Health Institute (hereinafter "ISP"), approved through Exempt Resolution No. 405/23 the technical guide on homeopathic products with the purpose of providing the guidelines and requirements for the request of the sanitary registration of these pharmaceutical products in order to provide complete and updated information that supports the quality, safety and efficacy of these products (the "Guide") ...
February 27, 2023 By: Leah Lively and Jack Darrington All employers should be aware of the recent decision by the United States Supreme in Helix Energy Solutions Group Inc. v. Hewitt dealing with exemptions under the Fair Labor Standards Act (“FLSA”). The Hewitt court held that a well-compensated employee paid a daily rate, rather than a fixed weekly or monthly salary, was not exempt from the FLSA and its rules regarding overtime pay ...
As a part of a reform of Russian data protection laws, Roskomnadzor adopted new rules for ban or restriction of cross-border transfer of personal data outside of Russia. Roskomnadzor may decide to ban or restrict cross-border transfer of personal data in the following cases: After the consideration of a data controller’s notification on cross-border transfer of personal data; Upon the motion of a competent authority to Roskomnadzor ...
Over the weekend, the EU announced its 10th sanctions package against Russia as a response to the invasion of Ukraine. The timing of the 10th sanctions package coincides with the anniversary for Russian invasion of Ukraine. The measures implemented in the new sanctions package include, inter alia: Additional sanction listings of 121 individuals and entities ...
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, Appeal No. 2023-1186 (Fed. Cir. Feb. 24, 2023) In this week’s Case of the Week, the Federal Circuit affirmed a permanent injunction requiring appellant Jazz Pharmaceuticals to de-list its U.S. Patent No. 8,731,963 from the Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalents Evaluation publication, colloquially known as the “Orange Book ...
Green tech presents a growth area and one in which the UK could flourish, but to do so requires capital investment and a clear strategy alongside developing the necessary skillset of the UK workforce. So how realistic is this in the current climate? Experience to date would suggest that the UK is lagging behind other countries in this sector and that unless more is done, we will miss out on the opportunity green tech offers ...
While a recent Pennsylvania ruling issued In February 2023 has been hailed as a victory for the underfunded school districts in the state, it could be a long road ahead before meaningful change makes its way to the students, teachers, and schools who need it the most ...
With only four months left before most changes to the federal Standards for Safeguarding Customer Information (“Safeguards Rule”) – a component of the Gramm-Leach Bliley Act (“GLBA”) that provides for the protection of consumers’ privacy and personal information – take effect, the Federal Student Aid Office is focused squarely on postsecondary educational institutions and third-party servicers, according to its recent announcement ...
From television commercials to naming rights for arenas, the topic of cryptocurrency has been hard to avoid. While cryptocurrency may be virtual, its creation or ’mining’ occurs in the real world. This mining poses a credit risk for utility companies, given the incredible amount of electricity required to operate a “mining” facility. For example, crypto mining company Core Scientific, Inc ...
On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023 ...
