Market accessOfficial

BfArM opens online portal for exemption from additional 8.5% manufacturer rebate

🇩🇪 BfArM · Wed 21 Oct 2026

Companies can now apply electronically to the German regulator for exemption from the extra rebate that applies from 1 January 2027, ahead of the rule taking effect.

Germany's Federal Institute for Drugs and Medical Devices (BfArM) has launched an online portal through which pharmaceutical companies can apply for exemption from the additional manufacturer rebate (Herstellerabschlag). The portal went live on 21 October 2026. Applications fall under Section 130a(1c) of Book V of the Social Code (SGB V), and the required supporting evidence is also submitted electronically.

The background is a statutory provision under which an additional manufacturer rebate of 8.5 percent applies to certain medicines from 1 January 2027. For medicines containing new active substances that are placed on the market for the first time from that date, the law provides an exemption. The condition is that at least five percent of participants in the medicine's clinical trials took part at trial sites in Germany.

BfArM says it developed an electronic application and review procedure that is available before the new rebate rules begin. The portal allows structured submission of the required information and evidence, which the agency uses to assess whether the legal conditions for exemption are met. BfArM decides on applications within the statutory deadline of three months.

The agency says it coordinated closely with pharmaceutical companies and industry associations when designing the portal and procedure. It has also published detailed procedural guidance and answers to frequently asked questions, and it offered an information event. Further details are available on the PharmNet.Bund website under the heading on exemption from the supplementary manufacturer rebate.

What it means for your team

  • Companies planning first launches of new-active-substance products in Germany from 1 January 2027 should check now whether they could qualify for the exemption.
  • Eligibility depends on at least five percent of clinical trial participants having been enrolled at German trial sites, so teams should be ready to document trial-site participation data.
  • Applications and evidence are submitted through the BfArM portal, and the agency has three months to decide, which should be factored into launch and pricing timelines.
  • BfArM's procedural guidance and FAQs on PharmNet.Bund are the reference points for preparing submissions.

Official source: BfArM ↗

Article written by VigiEye from the official source (BfArM). AI-assisted; check the source before acting.

More Market access All →