Information and FAQ on Manufacturer Surcharge Exemption Published

Germany's PharmNet.Bund has published detailed guidance and frequently asked questions concerning the new application procedure for exemption from the supplementary manufacturer surcharge, as per § 130a Abs. 1c SGB V.

The new regulation, introduced by the GKV-BStabG, allows pharmaceutical companies to apply for an exemption from the additional manufacturer surcharge for drugs with new active substances first placed on the market from January 1, 2027. This exemption is granted if at least 5 percent of the participants in the drug's clinical trials can be demonstrated to have taken place in Germany.

Information is now available on the PharmNet.Bund website detailing the application process. This includes requirements for substantiating the 5% criterion for clinical trials in Germany, as well as the necessary documentation and data formats. The Federal Institute for Drugs and Medical Devices (BfArM) will administer this process.

The electronic submission portal is scheduled to become available during the third week of October 2026. This initiative aims to encourage pharmaceutical research and clinical trials within Germany.