Netherlands · Medicines Evaluation Board · New drugs
Review target
-
Not published
Legal time limit
45 days
law
Steps
5
3 requirements
Application fee
€2,600
2026
An importer that the original holder did not appoint can bring a medicine from another member state onto the Dutch market. The product must be interchangeable with a Dutch reference medicine. The CBG grants the parallel licence within 45 days. This route does not apply to products with an EU licence from the European Commission. A nationally authorised Dutch reference medicine and an equal or nearly equal product bought in another member state.
The parallel import licence application is €2,600 for 2026.
1. Request a time slot (21 days); 2. Submit in the CBG electronic format; 3. Assessment of interchangeability (45 days); 4. Parallel licence; 5. Inform the reference holder.
Outcome: A parallel licence with the same indications and product information as the Dutch reference.
Legal basis: Geneesmiddelenwet Article 48; Regeling Geneesmiddelenwet Article 7.6
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 66 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
| Legal time limitlaw. This is a legal or official time limit, not an actual review time. | 45 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Parallel import licence applicationApplication · 2026 | €2,600 |
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, 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 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.