Spain · Spanish Agency of Medicines and Medical Devices · Cell and gene therapy
Review target
-
Not published
Legal time limit
210 days
regulation
Steps
5
8 requirements
Application fee
-
Gene therapy, somatic cell therapy and tissue engineered products that a hospital prepares occasionally, under specific quality rules, to fill an individual prescription for one patient need an authorization of use from the agency. The decision limit is 210 calendar days. The authorization covers only that hospital, lasts three years and can be renewed for five-year periods. Non-industrial advanced therapy medicines prepared and used in a Spanish hospital under a doctor's responsibility for an individual patient.
1. Hospital application; 2. Admission check (10 days); 3. Assessment (210 days); 4. Authorization of use; 5. Renewal (30 days).
Outcome: An authorization of use limited to the hospital. The product cannot be used elsewhere, exported or transferred. Valid for 3 years.
Legal basis: Real Decreto Legislativo 1/2015, article 47.3; Real Decreto 477/2014
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 250 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
| Validationregulation. Admission check. | 10 days |
| Legal time limitregulation. Maximum time to notify the decision from a valid application. This is an official time limit, not an actual review time. | 210 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in Spain: National scientific and regulatory advice, Compassionate use of investigational medicines, Authorization of a pharmaceutical manufacturer or importer. See all routes on the Spain 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 (21 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.