Germany · Federal Institute for Drugs and Medical Devices · New drugs
Review target
-
Not published
Legal time limit
60 days
regulation
Steps
3
5 requirements
Application fee
-
A company can give an unauthorised medicine free of charge to a group of patients with a life-threatening or seriously disabling disease that approved medicines cannot treat well. The medicine must be in clinical trials or under an authorisation application. The programme is notified to BfArM, or to the Paul-Ehrlich-Institut for its products, which confirms receipt within two weeks. It can start after confirmation if the authority does not object, and it ends after one year at the latest unless notified again. Groups of patients with serious diseases and no satisfactory authorised treatment, before the medicine is authorised.
1. Notify the programme; 2. Confirmation of a complete notification (14 days); 3. Programme runs.
Outcome: A confirmed notification; the programme may start unless the authority objects.
Legal basis: Arzneimittelgesetz (AMG) § 21 Abs. 2 Nr. 3; Arzneimittel-Härtefall-Verordnung (AMHV); Regulation (EC) No 726/2004 Article 83
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 379 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
| Validationregulation. Two weeks to confirm a complete notification. This is an official target in the law, not an actual review time. | 14 days |
| Legal time limitregulation. Up to 60 days for advanced therapy medicines or products not yet assessed in a trial approval. | 60 days |
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), Prescription status and switch to non-prescription, Traditional herbal medicine registration, Homeopathic medicine registration, National authorisation of vaccines, sera, blood products and allergens (Paul-Ehrlich-Institut), Official batch release by the Paul-Ehrlich-Institut, Hospital exemption for advanced therapy medicines. See all routes on the or explore them in the .
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 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.