Germany · Federal Institute for Drugs and Medical Devices · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
9 requirements
Application fee
€48,600
2026
When a medicine already has a national authorisation in one EU country, other countries recognise it on the basis of that country's assessment report. If Germany granted the first authorisation, it prepares the report within three months. If Germany is a concerned member state, it decides on recognition within three months after receiving the report. The EU-wide timetable is shown with the EU route. A medicine authorised nationally in one EU member state that the company wants to extend to Germany, or a German authorisation to extend to other member states.
The mrp with germany as rms, new substance, no reference, on top of the national fee (bfarm) is €48,600 for 2026.
1. Submit the identical dossier; 2. Assessment report (if Germany is the reference state) (91 days); 3. Recognition decision (if Germany is a concerned state) (91 days).
Yes. It relies on approvals from European Union (recognition).
Outcome: A German national authorisation identical to the reference authorisation. Valid for 5 years.
Legal basis: Arzneimittelgesetz (AMG) §§ 25b Abs. 2, 27 Abs. 1; Directive 2001/83/EC Chapter 4
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 182 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
| Decisionlaw. About 3 months after receiving the assessment report. This is an official target in the law, not an actual review time. | 91 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| MRP with Germany as RMS, new substance, no reference, on top of the national fee (BfArM)Application · 2026 · The fee is cut by 25 percent when the applicant shows it cannot expect an adequate economic return and there is a public interest in the medicine; by 50 percent when, in addition, cases are rare or the target group is small. | €48,600 |
| MRP with Germany as concerned member state, new substance (BfArM)Application · 2026 · The fee is cut by 25 percent when the applicant shows it cannot expect an adequate economic return and there is a public interest in the medicine; by 50 percent when, in addition, cases are rare or the target group is small. | €17,500 |
| MRP with Germany as concerned member state, known substance (BfArM)Application · 2026 · The fee is cut by 25 percent when the applicant shows it cannot expect an adequate economic return and there is a public interest in the medicine; by 50 percent when, in addition, cases are rare or the target group is small. | €14,200 |
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, 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, 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 (24 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.