Germany · Paul-Ehrlich-Institut · Vaccines
Review target
-
Not published
Legal time limit
213 days
law
Steps
4
11 requirements
Application fee
€2,000
2026
The Paul-Ehrlich-Institut is the German authority for sera, vaccines, blood products, tissue preparations, allergens, advanced therapy medicines and some other biomedicines. For these products it can grant the authorisation on the basis of the file, its own laboratory tests, or by observing the manufacturer's tests. The seven-month legal limit applies, and most of these products also need batch release. Vaccines, sera, blood products, allergens and other products in the Paul-Ehrlich-Institut's remit, sold only in Germany.
The national authorisation at the paul-ehrlich-institut: fee range 2,000 to 30,000 euros set by the work involved (amount shown is the minimum) is €2,000 for 2026.
1. Submit the application to the Paul-Ehrlich-Institut; 2. Assessment, with own testing if needed (213 days); 3. Decision; 4. Batch release before each batch is sold.
Outcome: A national marketing authorisation. Valid for 5 years.
Legal basis: Arzneimittelgesetz (AMG) §§ 21, 25 Abs. 8, 27, 32, 77 Abs. 2
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 213 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 7 months, not counting clock stops. This is an official target in the law, not an actual review time. | 213 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| National authorisation at the Paul-Ehrlich-Institut: fee range 2,000 to 30,000 euros set by the work involved (amount shown is the minimum)Application · 2026 · The fee is cut by 25 percent when no adequate economic return can be expected and there is a public interest; by 50 percent when, in addition, cases are rare or the target group is small. | €2,000 |
Other routes in Germany: Decentralised procedure with Germany as reference member state, Mutual recognition procedure (Germany as reference or concerned member state), Official batch release by the Paul-Ehrlich-Institut, Approval of tissue preparations, 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 (19 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.