Netherlands · Medicines Evaluation Board · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
6
2 requirements
Application fee
€31,990
2026
In mutual recognition, the reference state has already granted a licence and other states are asked to recognise it. A Dutch national licence can serve as the first phase, with the Netherlands as reference state. The CBG checks whether the dossier is up to date before it goes to other states. The same licence can later be extended to more states through a repeat use procedure. A product with a licence in one member state that the holder wants recognised in others, or recognised in the Netherlands.
The mrp with the netherlands as concerned state, new active substance is €31,990 for 2026.
1. Announce the plan (NL as reference state); 2. Time slot and request form (21 days); 3. CBG checks that the dossier is up to date; 4. Recognition by other states; 5. Dutch texts and mock-ups (NL as concerned state); 6. National licences.
Outcome: Recognition of the licence and a national Dutch licence when the Netherlands is a concerned state.
Legal basis: Directive 2001/83/EC Article 28; Regeling Geneesmiddelenwet Articles 3.2 to 3.4 and 7.3 to 7.4
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 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 |
|---|---|
| MRP with the Netherlands as concerned state, new active substanceApplication · 2026 | €31,990 |
| MRP with the Netherlands as reference state, new active substanceApplication · 2026 | €31,640 |
| MRP with the Netherlands as reference state, known active substanceApplication · 2026 | €22,340 |
| MRP or repeat use with the Netherlands as concerned state, known active substanceApplication · 2026 | €12,430 |
| Repeat use with the Netherlands as reference stateApplication · 2026 | €7,110 |
| Repeat use with the Netherlands as reference state, zero day (no new questions, no report update)Application · 2026 | €730 |
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, Decentralised procedure: 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, Dispensing status and non-prescription classification. See all routes on the Netherlands 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 (18 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.