Pharmaceutical and medicine device law
Our special knowledge in pharmaceutical and medical device law
At Rödl & Partner we combine our global experience together with our special knowledge in European law and International law, along with our expertise in comparative law, in the legal consultancy and thus we develop innovative, cross-border and intelligent solutions for our clients.
We also attribute great importance to the interdisciplinary component of this industry. When required in certain individual cases, we rely on our proven network of scientific experts to comprehend and evaluate technologically and scientifically complex issues and incorporate the results in our legal consultancy.
Considering that companies in these industrial sectors have to consider a multiplicity of aspects and legal requirements, it is in their interest to make versatile strategic and business decisions. In this context, Rödl & Partner offers a comprehensive know-how on:
- product classification and delimitation issues;
- marketability checks for the commerce in EU Member States and in third countries;
- consultancy regarding the import and export of products and on international trade law;
- comprehensive consultancy regarding product safety and product liability;
- consultancy on pesticides and contaminants;
- support for crisis management and communication (withdrawal, recall, RASFF, RAPEX);
- advice on hygiene and quality management;
- verification and optimization of product labeling;
- consultancy concerning product advertising and competition law issues (eg. prohibition of unfair commercial practices and misleading information, comparative advertising, nutrition and health claims, "green claims", "clean label", etc.);
- support on approval, registration and notification procedures at a EU level and in each of the Member States;
- registration and approval of food business operators; manufacturing or import authorizations for medicinal products;
- consultancy on antitrust compliance;
- contract design (eg. manufacturing, research, development and cooperation agreements, trade and distribution agreements, licensing agreements);
- intellectual property (eg. defense and enforcement of trademarks and patent rights);
- litigation before all courts (civil, administrative and criminal procedures), as well as representation in procedures and actions before the General Court of the European Union and the Court of Justice of the European Union;
- representation before national and European authorities.