Germany · Federal Institute for Drugs and Medical Devices · New drugs
Review target
-
Not published
Legal time limit
213 days
law
Steps
8
13 requirements
Application fee
€52,500
2026
A medicine sold only in Germany can get a national marketing authorisation. The Federal Institute for Drugs and Medical Devices (BfArM) handles it unless the product belongs to the Paul-Ehrlich-Institut. The law gives the authority seven months to decide, with the clock stopped while the applicant fixes deficiencies. A medicine with a new active substance that is meant only for the German market.
The national authorisation, new substance, no reference to other files (bfarm) is €52,500 for 2026.
1. Book a submission slot (21 days); 2. Request a procedure number; 3. Submit the application; 4. Validation; 5. Scientific assessment and decision (213 days); 6. Fix deficiencies (if asked); 7. Decision; 8. Renewal after five years.
Outcome: A national marketing authorisation with an authorisation number, valid for five years and then renewable. Valid for 5 years.
Legal basis: Arzneimittelgesetz (AMG) §§ 21 to 31
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 417 days end to end with the official step targets, of which up to 183 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
Targets, not actual review times
| Longest clock stoplaw. At most about 6 months for the applicant to fix deficiencies. | 183 days |
| Legal time limitlaw. About 7 months for the decision, 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, new 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. | €52,500 |
| Renewal of a national authorisation, basic fee (BfArM) |
Other routes in Germany: National authorisation based on literature (well-established use), 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 (29 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
What the applicant must provide or meet
| €5,900 |