Italy · Italian Medicines Agency · Cell and gene therapy
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
7 requirements
Application fee
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An advanced therapy medicine that is not authorised, and not under a specific clinical trial in Italy, can be prepared for an individual patient in an Italian public hospital, university clinic or research hospital. AIFA must authorise both the production and each use, which is allowed only in urgent cases with no valid alternative. A patient in danger of life or of serious harm to health, with no valid alternative and no authorised treatment for the same indication, treated under an individual medical prescription.
1. Production authorisation; 2. Request to use the product; 3. Use authorisation; 4. Yearly batch report.
Outcome: AIFA authorisation of production and of use for the patient. The production site reports the batches produced each year.
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 Italy: National classification after authorisation (class C(nn)) and reimbursement application, Early access through the Law 648/1996 list, Early access through the AIFA national fund (5% fund), Compassionate use of a medicine under clinical investigation. See all routes on the Italy 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.