Netherlands · Health and Youth Care Inspectorate · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
4 requirements
Application fee
-
When a registered medicine is temporarily unavailable, the inspectorate (IGJ) can let manufacturers, wholesalers and dispensers supply an alternative that has no Dutch licence but is authorised in another EU member state, the United Kingdom or a country with a mutual recognition agreement. The exemption is time-limited and published in the government gazette. A temporary shortage of a registered medicine with no adequate alternative available in the Netherlands.
1. Inspectorate assesses the shortage; 2. Exemption decision published; 3. Suppliers keep records.
Yes. It relies on approvals from European Union, United Kingdom (reference approval required, reference approval required).
Outcome: A time-limited exemption decision, possibly limited to certain indications.
Legal basis: Geneesmiddelenwet Article 40(3)(c); Regeling Geneesmiddelenwet Article 3.17a
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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.