Netherlands · Medicines Evaluation Board · New drugs
Review target
-
Not published
Legal time limit
210 days
law
Steps
5
11 requirements
Application fee
€9,380
2026
A company can apply for a licence for a medicine identical to one already on the market by fully referring to the dossier of that reference product. It needs consent from the reference licence holder and supplies only its own administrative data (module 1). A second licence for a product identical to an authorised one, with the holder's consent.
The national informed consent application is €9,380 for 2026.
1. Submit with consent letter; 2. Receipt confirmed; 3. Assessment (210 days); 4. Questions (clock stop); 5. Decision.
Outcome: A national licence (RVG number). Valid for 5 years.
Legal basis: Geneesmiddelenwet Article 42(5)(c); Directive 2001/83/EC Article 10c
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 210 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. Decision within 210 days of receipt. The clock stops while the company prepares answers. This is a legal or official time limit, not an actual review time. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| National informed consent applicationApplication · 2026 | €9,380 |
Other routes in Netherlands: National marketing authorisation, new active substance, National marketing authorisation, known active substance or line extension, National generic or hybrid application, Duplex marketing authorisation, National well-established use (bibliographic) application, Traditional herbal medicine registration, Parallel import licence, Decentralised procedure: Dutch steps and fees, Mutual recognition and repeat use: Dutch steps and fees, Licence for public health reasons (product marketed elsewhere in the EU), Compassionate use programme, Supply on physician statement (named patient), Temporary import exemption during shortages. 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 (20 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.