Pharmaceutical and medical device law

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The regulations governing human medicines, veterinary medicinal products and medical devices(e.g. implants, dental products, visual aids, laboratory diagnostics, etc.) are largely harmonised at European level. In particular there are controls for the classification, manufacture, approval, registration, marking, advertising, quality, distribution and monitoring of these products. At the same time the volume of regulation is steadily increasing with regard to safety and quality requirements and also with regard to marketing and advertising guidelines. In order to avoid or reduce the risk of sanctions and corporate liability, companies in the pharmaceutical industry have to ensure compliance with these standards through continuous expert review and corporate rules as well as procedures.
 

Comprehensive international and interdisciplinary consulting with legal representation for companies in the pharmaceutical industry

A team of specialised attorneys comprehensively advises and represents companies in the pharmaceutical industry across national borders on all questions which may arise during product development and the manufacture, distribution and marketing of the product. The range of consulting services includes, for example, regulatory questions relating to the product including recommendations for the creation of compliance organisation in the pharmaceutical sector, representation before German and European authorities and institutions, defence in criminal proceedings and assistance with non-compliance procedures, competition law and industrial property protection. We also attach great importance to the interdisciplinary components of this field and as required fall back on our proven network of scientific experts in order to understand and assess complex technological and scientific issues and enable the results to flow into our legal consulting. Pharmaceutical and medical device law is ultimately substantially influenced by European and international regulations. In view of this our legal consulting integrates our global experience, special knowledge of European and international law and expertise regarding the comparison of legal systems to enable us to develop innovative solution concepts.
   

Wide range of consulting services for pharmaceutical and medical product law

Our clients in the pharmaceutical sector have to observe numerous aspects and legal requirements starting with the first product idea including the development, manufacture and marketing of the product and as a result also have to make many varied strategic and entrepreneurial decisions. Rödl & Partner offers the following comprehensive expertise:
  • Product classification and legal differentiation
  • Marketability testing for EU member states and other countries
  • Approval, registration and notification procedures
  • Consulting for product safety and liability including assessment of liability risks
  • Support for crisis management and communication (recalls, product warnings)
  • Consulting for quality management (e.g. good manufacturing practice, good distribution practice)
  • Review and improvement of the product marking and product information texts
  • Consulting for product advertising, in particular regarding pharmaceutical advertising
  • Competition and antitrust law in the pharmaceutical sector (e.g. consulting for the prohibition of unfair commercial practices and restrictive agreements including price fixing and parallel trade)
  • Contract design (e.g. non-disclosure agreements, research and development contracts, contract manufacturing agreements, quality assurance agreements, distribution agreements including distribution contracts and licenses)
  • Intellectual property (e.g. defence and enforcement of intellectual property rights such as trademarks and patents)
  • Consulting in connection with legal questions concerning customs and foreign trade
  • Regulatory offence procedures and assistance with proceedings in all courts, including the European court of justice and the European court
  • Representation before German and European authorities

Contact

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Dr. Barbara Klaus

Partner

+49 911 9193 1999

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