Pharmaceutical Law / Medical Devices Law, and related Food Law
Our lawyers provide advice and represent our clients in the fields of German and European pharma law, medical product law and food supplements. This includes product launches including product design and product advertising as well as the complete support of approval procedures for drugs in the German and European approval system - both centralized and decentralized procedures - (Regulatory Affairs) and/or conformity and certification procedures of medical products and subsequent marketing. With more than 20 years‘ experience in the conduct of third-party opposition proceedings related to drug approval both in Germany and in Europe, our attorneys have extensive practical knowledge in this special field.
Questions of delimitation regarding product classification for drugs, medical products or food are part of our consultation just as the support of advertising campaigns, the judgment of advertising according to HWG [Law on Advertising in the Healthcare Sector] and UWG (Law against Unfair Competition) as well as the conduct of litigation under competition law (injunction and principal proceedings). Representation in patent infringement proceedings is also encompassed.
Our clients in these areas include German and international enterprises of the pharmaceutical industry, as well as associations and CRO. Our advising further focuses on pharma-specific contract law, e.g. clinical trials and post-marketing surveillance studies as well as on questions of pharmacovigilance and product liability. This also includes possible administrative and civil procedures.
We do not only assist our clients in traditional product differentiation matters, but also comprehensively advise them about the continuously changing opportunities arising from different product classifications – from configuration and presentation all the way to marketing and advertising. We deal with product classes of drugs, medical devices, biocides as well as food (traditional food such as teas or cough drops as well as Bach flowers and dietary supplements or balanced diets) on a regular basis. In addition to legal advice relating to questions about the Health Claims Regulation in advertising, we also offer consulting services and assistance on the national and European level when it comes to the filing of health claims applications.