Netherlands · Medicines Evaluation Board · Over-the-counter
Review target
-
Not published
Legal time limit
210 days
law
Steps
6
6 requirements
Application fee
€5,670
2026
Herbal medicines with a long tradition can be registered without clinical proof of efficacy. Efficacy is based on long use and experience. The product must have been used for at least 30 years, including at least 15 years in the EU, for use without a doctor. Herbal medicines for oral or external use or inhalation, with indications that do not need a doctor.
The national application, traditional herbal medicine is €5,670 for 2026.
1. Orientation meeting (optional); 2. Submit the dossier; 3. Receipt confirmed; 4. Assessment (210 days); 5. Questions (clock stop); 6. Decision.
Outcome: A national licence and entry in the register.
Legal basis: Geneesmiddelenwet Articles 42(8) and 45(2); Directive 2001/83/EC Chapter 2a
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 210 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. Decision within 210 days of receipt. The clock stops while the company prepares answers. This is a legal or official time limit, not an actual review time. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| National application, traditional herbal medicineApplication · 2026 | €5,670 |
| Annual fee, traditional herbal medicine licenceYearly · 2026 | €860 |
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, Homeopathic 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 (17 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.