Germany · Federal Institute for Drugs and Medical Devices · Over-the-counter
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
8 requirements
Application fee
-
Some well-known medicines do not need an individual authorisation. They are covered by a standard licence based on a monograph that the Federal Ministry of Health puts into force. The company follows the monograph and notifies BfArM and the state authority before it starts selling. Examples range from paracetamol to medicinal teas. Products that exactly match a published standard licence monograph.
1. Check the monograph; 2. Notify BfArM and the state authority; 3. Place on the market.
Outcome: No individual authorisation; the product may be sold after notification.
Legal basis: Arzneimittelgesetz (AMG) §§ 36, 67 Abs. 5; Verordnung über Standardzulassungen von Arzneimitteln
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 |
|---|---|
| No fees published. |
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), 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.