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
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 ...
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 ...
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 ...
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 ...
Impact on the activity of the pharmaceutical industry At the end of 2021, two laws were published to regulate the general framework for the prevention of corruption in the activity of companies: (i) Decree-Law 109-E/2021 of 9 December, which establishes the general rules for the prevention of corruption (“RGPC”) and (ii) Law 93/2021 of 20 December, which creates rules to protect whistleblowers (“RJPDI”) ...
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 ...
INTRODUCTION On 10 March, 2022, the Federal High Court sitting in Abuja in Suits No: FHC/ABJ/CS/791/2020: Fan Milk International A/S v. Mandarin Oriental Services BV and The Registrar of Trademarks and FHC/ABJ/CS/792/2020: Fan Milk International A/S v. Mandarin Oriental Services BV and The Registrar of Trademarks, delivered two landmark judgements and established certain principles on the determination of trademark infringement ...
In the light of the current geopolitical situation, including severe counter sanctions and restrictions imposed by the Russian Government, we would like to provide you with an update on the current IP regulation in Russia. Partial legalization of parallel imports On 29th March, the Russian government issued a Decree No ...
On March 30, 2022 the Division of Examinations of the United States Securities & Exchange Commission published the 2022 Examination Priorities. As in other years, the 2022 Examination Priorities document provides certain data regarding the scope of the examination program and the growth of the investment adviser community ...
Amy Leech, employment law associate and Shoosmiths’ mental health and wellbeing champion, considers the benefits of having an employee led mental health champion network within your business. As an employer, you will have lots of opportunities to look after your employees’ mental health. However, many organisations are still just paying lip service to it ...
Companies may purchase third party technology from time to time. When acquiring patents from outside the company, or from related entities, there are important factors to be considered. Here are certain issues for buyers when preparing a patent acquisition agreement. The buyer should first determine that all the record owners of the purchased Intellectual Property are party to the patent acquisition agreement. A particular patent may be assigned to a subsidiary of the seller ...
On March 3, 2022, President Biden signed the long-titled Ending Forced Arbitration of Sexual Assault and Sexual Harassment Act of 2021. Seen as a result of the #MeToo movement, this fairly simple amendment to Title 9 of the United States Code prohibits private employers from mandating that employees submit to arbitration of sexual assault and sexual harassment claims ...
China began legislating the protection of human genetic resources in 1998, at which time the Ministry of Science and Technology (MOST) and the Ministry of Health jointly formulated the Interim Measures for Administration of Human Genetic Resources; however, there had been no corresponding implementing rules to implement it in practice ...
When a patent is issued under the seal of the United States Patent and Trademark Office, it is signed by the Director of the USPTO or an Office official. The patent contains a grant to the patentee, and a printed copy of the specification and drawing is annexed to the patent and forms a part of it ...
Under the patent statute, any person who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent,” subject to the conditions and requirements of the law. The word “process” is defined by law as a process, act, or method, and primarily includes industrial or technical processes. The term “machine” used in the statute is self-explanatory ...
More recently, many more people are using fertility treatment to conceive; particularly same sex couples, single women and surrogates (Human Fertilisation and Embryology Authority data). This echoes a societal shift in so far as relationships, the formation of families and lifestyles are concerned. As such, there needs to be more emphasis on the development and evolution of the law and sector generally ...
Regulation (EU) 2017/745 of 5 April came into force on 26 May to create a single set of rules applicable to all medical devices, other than in vitro diagnostic medical devices. Here are some of the main changes to the rules that now come into force: 1. Broadening of the scope of application of the rules and of the concept of medical device With this Regulation, medical devices without a medical purpose that have characteristics similar to medical devices (e.g ...
Digemid authorized Pfizer the second conditional sanitary registration of the COVID-19 vaccine manufactured in the United States. A total of 4 vaccines authorized by the Peruvian health authority are added to this registry ...
Decree-Law 36/2021, which amends Decree-Law 176/2006 of 30 August ("Medicines Statute"), was published on 19 May. The new Decree-Law introduces a ban on the advertising of discounts on the price of medicines subject to medical prescription that are reimbursed by the National Health Service ("NHS") or that contain narcotic or psychotropic substances ...
