Netherlands · National Institute for Public Health and the Environment · Vaccines
Review target
-
Not published
Legal time limit
60 days
regulation
Steps
3
3 requirements
Application fee
-
Blood products and certain vaccines and other immunological medicines may only be supplied after the national institute RIVM has released the batch. The decision is due within 60 days. A batch tested and certified by the authority of another member state does not need Dutch release, but the certificate is sent to the Minister. Blood products, live vaccines, vaccines for first vaccination of young children or risk groups, vaccines in public immunisation programmes, and new immunological products.
1. Request release and send samples; 2. Release assessment (60 days); 3. Batch released.
Yes. It relies on approvals from European Union (recognition).
Outcome: Release of the batch for the Dutch market.
Legal basis: Regeling Geneesmiddelenwet Articles 6.1 to 6.4; Geneesmiddelenwet Article 28
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 60 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 limitregulation. This is a legal or official time limit, not an actual review time. | 60 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Netherlands: Parallel import licence, Licence for public health reasons (product marketed elsewhere in the EU), Compassionate use programme, Supply on physician statement (named patient), Temporary import exemption during shortages, Parallel procedure for market access and reimbursement. 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.