Netherlands · Medicines Evaluation Board · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
6 requirements
Application fee
€102,640
2026
The decentralised procedure is used to obtain a licence in several member states at once. With the Netherlands as reference state, the company books a CBG time slot. After all states agree, the company sends Dutch translations and mock-ups and the CBG issues a national licence. The shared EU steps are described under the EU rules. A product without a licence in any member state, to be authorised in the Netherlands and other member states.
The dcp with the netherlands as reference state, new active substance is €102,640 for 2026.
1. Request a time slot (NL as reference state) (21 days); 2. Submit; procedure and RVG numbers assigned; 3. Shared EU assessment; 4. National phase: Dutch texts and mock-ups; 5. National licence.
Outcome: A national Dutch licence (RVG number) at the end of the EU procedure.
Legal basis: Directive 2001/83/EC Articles 28 and 29; Regeling Geneesmiddelenwet Articles 3.2 and 3.3
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 21 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
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| DCP with the Netherlands as reference state, new active substanceApplication · 2026 | €102,640 |
| DCP with the Netherlands as reference state, known active substanceApplication · 2026 | €59,630 |
| DCP with the Netherlands as concerned state, new active substanceApplication · 2026 | €50,750 |
| DCP line extension with the Netherlands as reference stateApplication · 2026 | €46,550 |
Other routes in Netherlands: National marketing authorisation, new active substance, National marketing authorisation, known active substance or line extension, National generic or hybrid application, Informed consent application, Duplex marketing authorisation, National well-established use (bibliographic) application, Traditional herbal medicine registration, Homeopathic medicine registration, Parallel import licence, 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). 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 (22 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
| DCP with the Netherlands as concerned state, known active substanceApplication · 2026 | €29,810 |
| DCP copy application with the Netherlands as reference stateApplication · 2026 · A copy application has a dossier equal or nearly equal to the original DCP application; conditions apply. | €25,560 |
| DCP line extension with the Netherlands as concerned stateApplication · 2026 | €23,290 |