Netherlands · Health and Youth Care Inspectorate · New drugs
Review target
-
Not published
Legal time limit
56 days
law
Steps
6
5 requirements
Application fee
-
The law forbids supplying a medicine that has no Dutch licence, but the inspectorate (IGJ) can grant an exemption for supply on a physician statement. The physician records why the patient needs the product. A pharmacy, wholesaler, manufacturer or dispensing general practitioner then applies. The legal handling time is up to 8 weeks. A patient who cannot be treated with medicines authorised and available in the Netherlands.
1. Physician completes the statement; 2. Supplier requests an exemption; 3. Urgent handling (if needed); 4. IGJ assessment (56 days); 5. Exemption or refusal; 6. Keep records.
Outcome: A time-limited exemption that sets the quantity and the supply period.
Legal basis: Geneesmiddelenwet Article 40(3)(c); Regeling Geneesmiddelenwet Article 3.17
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 56 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
| Typical total timeobserved. The inspectorate reports an average handling time of about 4 weeks. | 28 days |
| Legal time limitlaw. Up to 8 weeks. This is a legal or official time limit, not an actual review time. | 56 days |
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, 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 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.