Product Regulation & Compliance
We are a leading law firm in providing advice in connection with regulated products. Our team has extensive experience in the following areas including the production and distribution of pharmaceuticals, medical products, chemicals and biocides, foods, commodities, cosmetics, tobacco products and CBD. Our specialists are pleased to also consult you on the interfaces to intellectual property, advertisement law, e-commerce as well as data privacy.
Furthermore, we advise our clients in dealing within areas of competition law (including unfair competition law), compliance, public procurement as well as commercial administrative law. As our client, you can benefit from our comprehensive expertise in all these areas.
We work in a pragmatic, interdisciplinary and efficient manner and have a comprehensive understanding on the functioning of the industries and markets of our clients.
Our team specializes on advising manufacturers and distributors of regulated products. We particularly assist our clients with complex issues at the interface between sector-specific regulation, intellectual property and technology law as well as competition and antitrust law.More
Our team advises and represents clients on all aspects of public procurement law and supports contractors and companies with all types of procurement projects. We have particularly profound experience in procedures regarding the procurement of software, IT as well as medical products.More
7th Edition, 2023, Editor Ulrich Grau, Chapter 13, p. 139 - 152
MLL Legal (Hrsg.), Praxishandbuch Produktregulierung, Bern 2023, S. 563 ff.
MLL Legal (Hrsg.), Praxishandbuch Produktregulierung, Bern 2023, S. 377 ff.
Event | Buchvernissage | Praxishandbuch Produktregulierung | 11. Dezember 2023 | Zürich
MLL Legal achieves landmark victory
James F. Reardon prendra la parole lors de la conférence « Registre central des bénéficiaires effectifs des personnes morales – Comment adapter l’identification des ayant-droits économiques et les approches KYC avant juin 2023 ? »
MLL Legal presents its new Management Committee
James Reardon, speaker at the Fit 4 Compliance conference in Zurich, 18 August 2022
Case law of the Swiss Federal Supreme Court: Product regulatory classification of CBD oils
The conceptual distinction between foodstuffs and cosmetic products is extremely important from a legal perspective (e.g. with regard to the legality of a product) and, as a result, is regularly addressed in practice, for example recently in the Federal Supreme Court decision 2C_576/2023 of January 18, 2024. In this decision, the Federal Supreme Court had to evaluate – in the sense of an obiter dictum – the relevance factors for distinguishing between foodstuffs and cosmetic products for a CBD oil. The most important points in this context are summarized below.More
European Reforms and Swiss Medtech: New Legislative Amendment on 1 November 2023 About Medical Devices That Have Non-medical Purpose
More than two years have passed after the breakdown of negotiations between Switzerland and the European Union (hereinafter: EU), followed by the set of new European regulations with the primary objective of enhancing the safety standards for medical devices. Switzerland has had to constantly adapt its legislation in this area to align with the heightened standards imposed by the EU.More
Swiss Regulatory Framework for the Sale of E-Cigarettes (Vapes) Today and Under the New Tobacco Products Act as of 2024
Due to numerous new forms of consumption, the tobacco market has changed in recent years. New products such as electronic cigarettes (e-cigarettes), disposable vapes and other nicotine-containing products for oral use are now available to consumers as alternatives to conventional (nicotine-containing) cigarettes and are one of the reasons why the number of cigarette packs sold in Switzerland is declining. These alternative products are becoming increasingly popular.More
Revision: Cannabis Regulation – New Authorization Mechanism for Dealing With Medical Cannabis
On 1 August 2022, not only the annual national holiday could be celebrated extensively in Switzerland. Particularly noteworthy is also the entry into force of the new requirements for the regulation of medical cannabis.
Cannabis was qualified as a prohibited narcotic in Switzerland until the end of summer 2022 – without further specification in relation to a medical application. Accordingly, the cultivation, importation, production, and marketing of cannabis required an exemption permit from the Federal Office of Public Health (FOPH).More
Legal Framework for the Use of Psychedelics in Switzerland
Just in time for summer, the miniseries «How to Change Your Mind» will be launched in July on the Netflix streaming platform. In this documentary series, author Michael Pollan and Co. analyse the history and applications of psychedelic substances such as LSD, psilocybin, MDMA and mescaline. According to experts, research with psychedelics (also known as hallucinogens) or related substances will increase worldwide in the coming years. The market launch of drugs containing MDMA for post-traumatic stress disorder (PTSD) or psilocybin for the treatment of depression is expected in the next five to ten years. The legal framework regarding the use of psychedelics in patients is very pragmatic in Switzerland and unique internationally. Switzerland is a leader in the research and use of psychedelics in psychiatry and is considered an innovation driver in this field. Nevertheless, the regulatory hurdles for researchers and patients are still extremely high. In this article we elaborate on the requirements under which psychedelics may be used in Switzerland today.