Mr Daniel Kendziur

Daniel Kendziur

Updates

Healthcare & Life Sciences

Binding implications of notification under German Drug Act and qualification of preparation as presentation drug
Germany | 07 October 2020

The Frankfurt am Main District Court recently examined whether a Federal Institute for Drugs and Medical Devices notification can establish whether a preparation is a medicinal product subject to authorisation. In principle, the courts are bound by the institute's assessment unless the notification is null and void. However, if a notification is redacted in such a way that its constituent elements are unknown, the court must decide whether the preparation is a functional medicinal product or a presentation drug.