Italy · Italian Medicines Agency · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
6
6 requirements
Application fee
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A medicine still in clinical trials can be used outside a trial for patients with serious or rare diseases, or in life-threatening conditions, when the doctor finds no valid alternative. The manufacturer supplies it free of charge and the local ethics committee approves each patient. AIFA is notified and can intervene at any time. A patient who cannot enter a clinical trial, or who benefited in a completed trial of at least phase II, and has no valid alternative. The medicine must be in trials or under a marketing authorisation application.
1. Company programme notice (programmes only); 2. Physician request; 3. Ethics committee opinion; 4. Notice to AIFA (3 days); 5. Free supply and treatment; 6. Programme closure.
Outcome: Free supply of the medicine for the named patient or for patients in a company programme, after a favourable ethics committee opinion.
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 48 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
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 marketing authorisation (full dossier), National marketing authorisation (well-established use, bibliographic), Decentralised procedure with Italy as reference member state, Mutual recognition procedure with Italy as reference member state, Mutual recognition or decentralised procedure with Italy as concerned member state, Parallel import authorisation, 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), Advanced therapy prepared on a non-routine basis (hospital exemption), State batch control of vaccines and other immunological medicines. See all routes on the Italy page 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
What the applicant must provide or meet