Germany · Federal Institute for Drugs and Medical Devices · New drugs
Review target
-
Not published
Legal time limit
213 days
law
Steps
4
10 requirements
Application fee
€22,100
2026
For active substances that have been in general medical use in the EU for at least ten years, the applicant can replace its own pharmacology, toxicology and clinical results with published scientific evidence. Quality data are still needed. BfArM accepts these applications only when no suitable reference product exists for a generic or hybrid application. Known active substances in general medical use in the EU for at least ten years, when no suitable reference product exists.
The national authorisation, known substance, no reference to other files (bfarm) is €22,100 for 2026.
1. Book a submission slot; 2. Submit the application; 3. Assessment and decision (213 days); 4. Decision.
Outcome: A national marketing authorisation. Valid for 5 years.
Legal basis: Arzneimittelgesetz (AMG) § 22 Abs. 3
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 213 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Legal time limitlaw. About 7 months, not counting clock stops. This is an official target in the law, not an actual review time. | 213 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| National authorisation, known substance, no reference to other files (BfArM)Application · 2026 · The fee is cut by 25 percent when the applicant shows it cannot expect an adequate economic return and there is a public interest in the medicine; by 50 percent when, in addition, cases are rare or the target group is small. | €22,100 |
Other routes in Germany: National marketing authorisation (new active substance), National generic authorisation, Decentralised procedure with Germany as reference member state, Mutual recognition procedure (Germany as reference or concerned member state), Standard licence (monograph route), Prescription status and switch to non-prescription, Traditional herbal medicine registration, Homeopathic medicine registration, Compassionate use programme. See all routes on the Germany page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (18 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.