Germany · Federal Institute for Drugs and Medical Devices · New drugs
Review target
-
Not published
Legal time limit
304 days
law
Steps
6
10 requirements
Application fee
€92,800
2026
In the EU decentralised procedure, the applicant can choose Germany as the reference member state. BfArM, or the Paul-Ehrlich-Institut for its products, then drafts the assessment report and product texts for all countries involved. German rules add a booked submission slot, a procedure number and national fees. The general EU timetable is shown with the EU route. A medicine not yet authorised in any EU country, for several EU markets at once, with Germany leading the assessment.
The dcp with germany as rms, new substance, no reference (bfarm) is €92,800 for 2026.
1. Book a slot with BfArM (21 days); 2. Request a procedure number; 3. Submit the identical dossier; 4. Assessment report by Germany (120 days); 5. Agreement and German national phase (304 days); 6. Renewal.
Outcome: A German national authorisation at the end of the national phase, alongside the authorisations of the other member states. Valid for 5 years.
Legal basis: Arzneimittelgesetz (AMG) §§ 25b, 27 Abs. 3; Directive 2001/83/EC Article 28
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 445 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. The seven-month national limit is extended by three months for this procedure, about ten months in total. This is an official target in the law, not an actual review time. | 304 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| DCP with Germany as RMS, new substance, no reference (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. | €92,800 |
| DCP with Germany as RMS, known substance, no reference (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. | €44,200 |
| DCP with Germany as RMS, known substance, full reference (generic) (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. | €33,100 |
| DCP with Germany as concerned member state, new substance (BfArM)Application · 2026 | €20,300 |
| Paul-Ehrlich-Institut as RMS: extra fee of 8,000 to 10,000 euros on top of the national fee range (amount shown is the minimum)Application · 2026 | €8,000 |
Other routes in Germany: National marketing authorisation (new active substance), National authorisation based on literature (well-established use), National generic authorisation, 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, 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 (27 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.