Netherlands · Medicines Evaluation Board · Over-the-counter
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
6 requirements
Application fee
-
When it grants a licence, the CBG also decides the dispensing category: prescription only (UR), pharmacy only (UA), pharmacy and drugstore (UAD) or general sale (AV). For EU-licensed products that are not prescription only, the CBG sets the Dutch category. The category is shown on the pack. Every licence. A holder can also ask for a change of category based on new data.
1. Category decided with the licence; 2. New decision on new data (switch).
Outcome: A dispensing category decision.
Legal basis: Geneesmiddelenwet Articles 56 to 59; Regeling Geneesmiddelenwet Articles 4.1 and 4.2
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, 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. 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.