BfArM to Host Information Event on New Manufacturer Discount Application Process
Germany's Federal Institute for Drugs and Medical Devices (BfArM) is inviting pharmaceutical companies to an information session on the new application procedure for exemption from the manufacturer's discount.
The Federal Institute for Drugs and Medical Devices (BfArM) will hold an information event on October 20, 2026, detailing a new application procedure for exemption from the manufacturer's discount under § 130a Absatz 1c SGB V. The Paul-Ehrlich-Institut (PEI) will also participate in presenting the process.
The event targets pharmaceutical companies planning to seek marketing authorization for drugs with novel active substances and, concurrently, apply for an exemption from the additional manufacturer's discount. This exemption applies to drugs first brought to market from January 1, 2027, onwards.
Introduced by the GKV-BStabG, the regulation allows pharmaceutical entrepreneurs to request exemption from the additional manufacturer's discount. This is granted if at least 5 percent of participants in clinical trials for the drug can be proven to be from Germany. BfArM is responsible for establishing and implementing this procedure.
The information session will cover the prerequisites for application, methods for determining the relevant study population, required documentation, and the submission process via the BfArM web portal. Attendees will have the opportunity to ask questions to representatives from BfArM and PEI.