Netherlands · Medicines Evaluation Board · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
1 requirements
Application fee
-
The CBG and the National Health Care Institute (Zorginstituut) assess at the same time whether a new medicine can enter the Dutch market and the basic insurance package. The company can send its reimbursement dossier before the licence is granted. The CBG states that the total assessment takes about 3 months less than normal. It has been a standard option since February 2022. New outpatient prescription medicines or expensive hospital medicines, assessed in the EU central procedure and not yet on the Dutch market.
1. Early contact with both project leaders; 2. Reimbursement dossier sent before the licence; 3. Licence and reimbursement assessed in parallel.
Outcome: Earlier start of the reimbursement assessment, run in parallel with the licence.
Legal basis: Joint working procedure of the CBG and the Zorginstituut (structural since February 2022)
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).
Official step durations
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 |
|---|---|
| No fees published. |
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, 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). 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.