[Pharmaceutical Products and Medical Devices: Authorization and Conformity Assessment Procedures, Regulatory Data Protection, Patent Protection and Supplementary Protection Certificate].

Abstract

Introduction: Pharmaceutical products and medical devices can pose a potenzial risk to health. They may therefore only be placed on the market if their safety, efficacy and quality have been proven. The safety requirements are not to be understood as absolute. Rather, the safety assessment is based on a risk-benefit assessment. Pharmaceutical products and medical devices are subject to different requirements, whereby pharmaceutical products are subject to an authorization procedure, while medical devices have to undergo a conformity assessment procedure. This article first sets out the basic principles and the system of therapeutic products law and discusses the categorization of pharmaceutical products and medical devices as well as their differentiation from other products, in particular foodstuffs and cosmetics. The main features of placing pharmaceutical products on the market are then presented, with a focus on the authorization procedures for pharmaceutical products. This article also provides a brief overview of the protection rights for pharmaceutical products. In addition to the protection rights under the Therapeutic Products Act, the regulatory data protection, there are also protection rights under intellectual property law. In addition to the patent, intellectual property law grants another protection right for products that require an authorization in order to be placed on the market. The supplementary protection certificate, which is only granted to medicinal products and plant protection products as products that require an authorization, is intended to partially compensate for the lack of possibility of using the patented invention during the approval process. Due to the scope of the medicinal products and intellectual property law regulations mentioned, this article must limit itself to selected areas in an overview.