Germany · Federal Institute for Drugs and Medical Devices · Over-the-counter
Review target
-
Not published
Legal time limit
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Not published
Steps
3
4 requirements
Application fee
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In Germany, prescription status is set by a list in a federal ordinance. The Federal Ministry of Health can remove a substance from prescription status when experience shows it is safe without medical supervision. It first hears an expert committee, and the ordinance needs the consent of the Bundesrat. Medicines that are not prescription-only are still sold only in pharmacies unless the law releases them for sale elsewhere. A company or expert body seeks non-prescription status for a substance on the prescription list.
1. Proposal to change the prescription list; 2. Expert committee hearing; 3. Ministry ordinance with Bundesrat consent.
Outcome: An amended ordinance that releases the substance (for some strengths, forms or uses) from prescription status.
Legal basis: Arzneimittelgesetz (AMG) §§ 43, 48, 53; Arzneimittelverschreibungsverordnung (AMVV)
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), Standard licence (monograph route), 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 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.