Netherlands · Medicines Evaluation Board · Over-the-counter
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
3 requirements
Application fee
€3,890
2026
Homeopathic products for oral or external use, with no therapeutic indication and a high dilution, are registered without preclinical or clinical data. Products with a self-care indication must show that the homeopathic use is described in homeopathic literature. Homeopathic medicines made by a homeopathic manufacturing method.
The homeopathic product with indication or other route is €3,890 for 2026.
1. Submit the dossier; 2. Quality and safety assessment; 3. Decision.
Outcome: Registration with an RVH number.
Legal basis: Geneesmiddelenwet Article 42(3) and (4); Regeling Geneesmiddelenwet Article 7.1(d) and (e)
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 |
|---|---|
| Homeopathic product with indication or other routeApplication · 2026 | €3,890 |
| Homeopathic product without indication, oral or external useApplication · 2026 · Package price for all strengths of a series made from the same homeopathic stock. | €1,950 |
| Annual fee per homeopathic product registrationYearly · 2026 | €55 |
Other routes in Netherlands: 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, Dispensing status and non-prescription classification. See all routes on the Netherlands page or explore them in the Regulatory section.
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.