Please be informed that a new Counter-Sanctions Regime of Making Payments in IP-Related Agreements in Russia was established by the Presidential Decree No. 322 dated May 27th, 2022 “On the temporary procedure for fulfilling obligations in respect of certain right holders” (“Decree No. 322”). It came into force on the date of signing. Download the file to see more. https://alrud ...
Metaverse, is the virtual-reality space in which users interact via computer-generated environment, something similar to what already exists on gaming platforms. It is a simulated digital environment that encompasses a network of 3D virtual worlds focused on social connection. Non-fungible tokens and their underlying technology have surged the market value of digital assets ...
Proposal for a regulation of the European Parliament and of the Council on standards of quality and safety Current regulatory framework and scope of application The EU regulatory framework on substances of human origin (“SoHO”) is reflected in Directives 2002/98/EC for blood and 2004/23/EC for tissues and cells ...
While their advent was initially hailed as a revolution for the creative industries, non-fungible tokens (“NFTs”) appear to have lost significant steam over the past months with the Wall Street Journal reporting that NFT sales have dropped by 92% over September 2021 figures ...
Acquisition of intended exclusively for the production of parenteral bags INFARMED - the Portuguese National Authority for Medicines and Healthcare Products (“Infarmed”) has recently adopted Decision 089/CD/2022, concerning the regulatory framework for the acquisition of medicines without a national Marketing Authorisation (“AIM”), intended exclusively for the production of parenteral bags ...
Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use introduced additional requirements for the labelling of investigational and auxiliary medicinal products, in particular, for unauthorised medicinal products, in order to eliminate divergences in approach among Member States ...
In June 2022, at one of the annual meetings of the Employment, Social Policy, Health and Consumer Affairs (“EPSCO”) Council, health ministers expressed their concerns regarding the legislative transition to Regulation (EU) No 2017/745 of the European Parliament and of the European Council of 5 April 2017 on medical devices (“MDR”) and to Regulation 2017/746 of the European Parliament and of the European Council of 5 April 2017 on in vitro diagnostic medical devi
We are glad to present you a current digest of the most significant bills, regulatory changes, and measures affecting the pharmaceutical and healthcare industry for the period from June to October 2022. Follow the link to download the digest. ALRUD_Newsletter_Key_changes_in_Life_Sciences_for_the_June-October_2022_period_upd ...
On December 3, the U.S. Patent and Trademark Office (“USPTO”) will make a major change to how it processes trademark applications, which is anticipated to affect filing strategies, work flow, and even budgets. Brand owners in the U.S. might be wondering what they need to know about the Trademark Modernization Act’s (“TMA”) shortened office action response deadline ...
Since 2013, the National Medical Products Administration ("NMPA")Center for Drug Evaluation("CDE")has been releasing a Drug Review Annual Report ("Report")each year, which summarizes its work on drug review of the previous year ...
Fast-growing e-commerce has changed lifestyles and invented new ways of consumption, amid which demand has rapidly increased for Internet-based medical services such as online drug sales and online medical diagnosis. Since the regulation and promotion of "Internet-based healthcare services" was included as part of the Outline of the "Healthy China 2030" Plan, China's Internet healthcare industry has been flourishing, channeled by a series of favorable policy decisions ...
On appeal, the trademark infringement was no longer in dispute. Still, the decision has a fundamental interest in the intellectual property legal space. The judgement deals with principal issues related to compensation claims for trademark infringement where the infringement and alleged damage merely relates to a subpart of the infringer’s ads and turnover. Norgesgjerde and Vindex (the original plaintiffs) claimed total damages and compensation in excess of NOK 10 million ...
As the regulation system on human genetic resources ("HGR"), biosecurity and laboratory animals is experiencing continuous improvement, enforcement actions of the Ministry of Science and Technology ("the MOST") have become more active and tight in recent years ...
Hemp seeds have been eaten in the EU for a long time. The seeds may contain trace amounts of tetrahydrocannabinol (THC) because this cannabinoid is a natural constituent of the cannabis plant from which the seeds originate. The EU regulator has decided to harmonize the maximum levels for THC in hemp seeds throughout the Union within the food contaminants framework. Commission Regulation 2022/1393 of 11 August 2022 amends the annex to Regulation No1881/2006 on food contaminants to this effect ...
Introduction Mdeon, the legally recognised Belgian ethical platform for healthcare professionals and the pharmaceutical industry, announced several new ethics rules applying from 1 January 2023. The present blog post discusses their practical importance for the broader healthcare community, and particularly (i) several new ethic rules in light of the ascendant trend of virtual and hybrid scientific events, and (ii) new maximum hospitality amounts that can be offered to healthcare professionals ...
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 ...
Americans have increasingly accepted meat and dairy alternatives as staples in their daily diets. For example, recent market research shows that two out of every five U.S. consumers plan to purchase plant-based meat products in 2023. The prevalence of these forms of alternative protein has set the stage for a semantic — and potentially paradigm-shifting — dispute over the very meaning of the terms "meat," "milk" and "dairy ...
Ohio legislators are once again attempting to transform the state’s medical marijuana control program after a similar effort stalled out last year. Proponents of the proposed legislation, Senate Bill 9, seek to expand medical marijuana access to Ohioans and revamp the structure of the current program. The proposal would establish the Division of Marijuana Control (“DMC”) under the Department of Commerce ...
Introduction An EU Regulation on the making available on the Union market as well as export from the Union of certain commodities and products associated with deforestation and forest degradation (“Deforestation Regulation”) was agreed upon by the EU legislators in December 2022. The European Parliament has now green-lighted the Provisional Agreement at this month’s plenary session ...
The EU regulator has harmonized the maximum levels for tetrahydrocannabinol (THC) in hemp seeds throughout the Union within the food contaminants framework. This EU harmonization puts pressure on conservative national food laws such as the Belgian Royal Decree of 31 August 2021, which treats hemp seeds as a prohibited food.The situation in Belgium, however, is changing to better align it with EU law ...
On 16 March 2023, in Joined Cases C‑438/21P to C‑440/21P, the Court of Justice of the European Union (CJEU) interpreted the concept of a ‘global marketing authorisation’. It held that Article 6(1) of Directive 2001/83 (the Community Code) sets out exhaustively the line extensions for which the marketing authorisations (MAs) will fall under the same global MA as the initial MA ...
On June 1, 2023, China's Ministry of Science and Technology ("MOST") officially released the Implementation Rules for the Regulation of Human Genetic Resources Administration ("Implementation Rules"), which will come into effect on July 1, 2023 ...
On 17 May 2023, the Belgian Medicines Agency (FAMHP) announced that marketing authorisation holders (MAHs) have three years to comply with the prohibition of “negative formulations” on the packaging of medicinal products for human use. Such negative formulations include “gluten-free”, “lactose-free”, “ethanol-free” or “no colourings” ...
