Germany · Paul-Ehrlich-Institut · Biologics
Review target
-
Not published
Legal time limit
152 days
law
Steps
3
2 requirements
Application fee
€2,000
2026
Tissue preparations that are not processed industrially and use processes well known in the EU need an approval from the Paul-Ehrlich-Institut instead of a full marketing authorisation. The same applies to certain stem cell preparations from blood for autologous or directed use. The decision is due within five months. Tissue preparations made with well-known, non-industrial processes, and certain blood stem cell preparations.
The tissue preparation approval (musculoskeletal, skin, eye and other tissues): fee range 2,000 to 30,000 euros (amount shown is the minimum) is €2,000 for 2026.
1. Submit the approval application; 2. Assessment and decision (152 days); 3. Approval.
Outcome: A written approval with an approval number.
Legal basis: Arzneimittelgesetz (AMG) § 21a
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 152 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
| Legal time limitlaw. About 5 months, not counting clock stops. This is an official target in the law, not an actual review time. | 152 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Tissue preparation approval (musculoskeletal, skin, eye and other tissues): fee range 2,000 to 30,000 euros (amount shown is the minimum)Application · 2026 | €2,000 |
Other routes in Germany: Decentralised procedure with Germany as reference member state, Mutual recognition procedure (Germany as reference or concerned member state), National authorisation of vaccines, sera, blood products and allergens (Paul-Ehrlich-Institut), Official batch release by the Paul-Ehrlich-Institut, 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.