Netherlands · Health and Youth Care Inspectorate · Cell and gene therapy
Review target
-
Not published
Legal time limit
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Not published
Steps
3
2 requirements
Application fee
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Advanced therapy medicines normally need an EU licence. A hospital exemption allows custom-made preparation for an individual patient, on a non-routine basis, used in a Dutch hospital under a physician's responsibility. The inspectorate (IGJ) must approve preparation and use and checks that traceability, pharmacovigilance and quality match licensed products. A cell, gene or tissue-engineered product prepared non-routinely for an individual patient in a hospital in the Netherlands.
1. Submit the hospital exemption application form; 2. IGJ approval; 3. Ongoing supervision.
Outcome: IGJ permission to prepare and use the product.
Legal basis: Geneesmiddelenwet Article 40(3)(d) and 40(8); Regulation (EC) 1394/2007 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).
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: Compassionate use programme, 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.