As a part of our conversation with clients webinar series, Helen Wilson, Head of Legal at Weetabix joined Sebastian Price, Partner at Shoosmiths to talk about her experience of career development including success insights, job changes, individual versus organisational impact on progression and more ...
Covid-19 has had an impact on ongoing consumer contracts and their relations with suppliers. The rapid spread of the virus led the authorities to declare State of Disaster in the country, raising concern about the (i) fulfillment of consumer contracts of goods and services and (ii) an eventual price manipulation ...
On October 3rd ALRUD Law Firm Partner Anton Dzhuplin joined a workshop of international Conference “What is happening in pharmaceutical market?”, which took place at “PHARMASTRATEGIES-2017” summit. The conference annually brings together Country managers, CEOs, top-managers of pharmaceutical manufacturers, distributors and retailers, heads of associations, representatives of regulatory authorities, professional and business media ...
Article 81 of the Food Safety Law of the PRC (the “Food Safety Law”), revised in 2015, stipulates that the product formulas for infant formula milk powder shall be registered with the food and drug administration under the State Council ...
As COVID-19 continues to spread, CMS has issued guidance to various healthcare providers, including, among others, home health agencies, nursing homes, and hospitals that are caring for the nation’s most at-risk patient populations.The guidance is intended to curb transmission and ensure healthcare providers have the information and resources necessary to respond to patient needs ...
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 ...
Research and development ("R&D") of medicinal products is fundamentally important in peoples’ daily lives. This is true both from an individual perspective – when considering the objective of identifying and treating pathologies (with a consequent increase in the quality of life of patients) – and from a collective perspective, when considering the role of R&D in controlling the spread of diseases and in eradicating them altogether ...
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 October 8, 2023, theScientific and Technological Ethics Review Regulation (Trial)("Scientific and Technological Ethics Regulation") was jointly published by the China's Ministry of Science and Technology ("MOST"), the Ministry of Education, the Ministry of Industry and Information Technology, and other seven (7) departments/institutions, which was followed by a press conference held next day by the MOST to respond to media inquiries ("Press Conference") ...
The concept of "patient-centered" has become the core guiding principle in current research and development ("R&D") of drugs. "Patient-centered" drug R&D refers to the process of drug discovery, design, implementation and decision-making based on the patient's point of view, with the aim of efficiently developing clinically valuable drugs that better meet the needs of patients ...
Belgium is welcoming a significant development in the field of veterinary medicine law. The Act of 11 July 2023 containing various provisions on health, which entered into force on 8 September 2023, introduces changes across a wide spectrum of healthcare domains, which are encompassed in approximately 20 chapters. In this blog post, we provide an overview of the key changes related to the marketing of veterinary medicines set out in Chapters 4 and 14 of the new Law ...
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 ...
Pharmaceuticals and medical devices in Malaysia are governed by the following main legislation and regulations:the Sale of Drugs Act 1952 (SODA 1952);the Control of Drugs and Cosmetics Regulations 1984 (CDCR 1984);the Dangerous Drugs Act 1952 (DDA 1952);the Poisons Act 1952 (PA 1952);the Medicines (Advertisement and Sales Act) 1956 (MASA 1956); andthe Medical Device Act 2012 (MDA 2012) ...
For as long as there have been rules of evidence and courtrooms, there have been products that can impair litigants or witnesses—and products whose use carries the potential to trigger certain stigmas in the eyes of the finders of fact. Cannabis, which has been around longer than nearly every judicial system in the world and the subject of political and popular debate in the United States for the past century, may be the paradigmatic product at the moment ...
If a branded medicine and its generic version are put on the EEA market by economically linked undertakings, is a parallel importer then allowed to rebrand and repackage the imported generic version as the branded reference medicine? This has been a hotly debated issue in recent years and recently led the Brussels Court of Appeal (CoA) to refer three questions to the European Court of Justice (ECJ) (Cases C-253/20 and C-254/20) ...
With the Corona crisis, countries such as Germany, France and the Czech Republic have already announced bans on exports of protective gear to avoid shortages at their countries. But is this in conformity with the principle of free movement of goods as provided for in articles 34-36 TFEU? This principle is one of the cornerstones of the European Union's internal market which implies that national barriers to the free movement of goods within the EU need to be removed ...
It's that time of year again – CLE Compliance season! With the impact of COVID-19, we know many of our clients have found it challenging to meet their annual CLE requirements. Bradley is pleased to offer you a complimentary, online CLE addressing key topics with thought-leading speakers from inside and outside of Bradley. This CLE program includes 1 ethics hour and 2 general hours ...
The new abbreviated regulatory approval pathway for “biosimilar” and “interchangeable” types of biologic drug products was implemented in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Patient Protection and Affordable Care Act of 2010. The details about the use of this pathway were left for further development through Food & Drug Administration (“FDA”) action ...
In the context of the current sanitary alert, several bills of law have been filed with Congress, seeking to regulate certain aspects associated to states of emergency and sanitary crises in particular.To such ends, the bills that stand out are:I. Bill prohibiting and penalizing price increases in the face of epidemics or pandemics:On Tuesday 17 March 2020, a bill was filed with the Lower Chamber (Newsletter 13 ...
On 22 September 2023, the Royal Decree of 13 September 2023 establishing specific rules on the public procurement of biological medicinal products was published in the Belgian State Gazette (“Royal Decree”) ...
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” ...
IP landscape While the world is in the grip of the deadly COVID-19 pandemic, the patenting of pharmaceutical and biological compositions and the launch of generic products is even more hotly debated than before, particularly in the world's developing and least-developed countries ...
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 ...
