Netherlands · Medicines Evaluation Board · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
5 requirements
Application fee
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A manufacturer can ask the CBG to approve a programme that makes an unlicensed medicine available to a group of patients with a serious disease for which no registered medicine exists. A licence application must be filed or clinical trials must be ongoing. The inspectorate supervises the programme. A cohort of patients with a chronic, seriously debilitating or life-threatening disease that registered medicines cannot treat satisfactorily.
1. Manufacturer submits the request and programme; 2. CBG assessment; 3. Approval; 4. Inspectorate supervision.
Outcome: CBG approval of the programme, possibly with conditions.
Legal basis: Geneesmiddelenwet Article 40(3)(f); Regeling Geneesmiddelenwet Article 3.18; Regulation (EC) 726/2004 Article 83
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), 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 (12 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.