Germany · Federal Institute for Drugs and Medical Devices · Over-the-counter
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
9 requirements
Application fee
€6,400
2026
Homeopathic medicines without a stated indication are entered in a register kept by BfArM instead of being authorised. The application does not include claims of effect or clinical data. A company that sells up to 1,000 packs a year can be exempt, with some exceptions. Homeopathic medicines sold without a stated therapeutic indication.
The homeopathic registration, national procedure (bfarm) is €6,400 for 2026.
1. Submit the registration application; 2. Registration.
Outcome: Entry in the register with a registration number.
Legal basis: Arzneimittelgesetz (AMG) §§ 38, 39
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 |
|---|---|
| Homeopathic registration, national procedure (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. | €6,400 |
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, Traditional herbal 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.