Germany · Federal Institute for Drugs and Medical Devices · Over-the-counter
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
13 requirements
Application fee
€15,600
2026
Herbal medicines with a long tradition can be registered instead of authorised. The applicant shows medical use for at least 30 years, including 15 years in the EU, and safety under the stated conditions. Use must be oral, external or by inhalation, without medical supervision. The registration lasts five years and can be renewed. Herbal medicines with at least 30 years of medical use, 15 of them in the EU.
The traditional herbal registration without list or monograph (bfarm) is €15,600 for 2026.
1. Submit the registration application; 2. Assessment; 3. Fix deficiencies (if asked); 4. Registration.
Outcome: A registration with a registration number, valid for five years. Valid for 5 years.
Legal basis: Arzneimittelgesetz (AMG) §§ 39a to 39d
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Traditional herbal registration without list or monograph (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. | €15,600 |
| Traditional herbal registration with list or monograph (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. | €9,900 |
Other routes in Germany: National marketing authorisation (new active substance), 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, 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 (20 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.