Germany · Federal Institute for Drugs and Medical Devices · Generics
Review target
-
Not published
Legal time limit
213 days
law
Steps
4
11 requirements
Application fee
€16,000
2026
A generic can refer to the reference product's pharmacology, toxicology and clinical data once the reference has been authorised for at least eight years, also when it was authorised in another EU member state. The generic can be sold only ten years after the first authorisation of the reference, or up to eleven years in some cases. A similar biological medicine adds suitable preclinical or clinical data on the differences. Copies of medicines whose reference product has been authorised in Germany or the EU for at least eight years.
The national authorisation, known substance, full reference to another file (bfarm) is €16,000 for 2026.
1. Submit the application; 2. Confirmation of the reference product (30 days); 3. Assessment and decision (213 days); 4. Decision.
Outcome: A national marketing authorisation as a generic. Valid for 5 years.
Legal basis: Arzneimittelgesetz (AMG) § 24b
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 243 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, full reference to another file (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. | €16,000 |
Other routes in Germany: National marketing authorisation (new active substance), National authorisation based on literature (well-established use), 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 (19 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.