Italy · Italian Medicines Agency · New drugs
Review target
-
Not published
Legal time limit
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Not published
Steps
5
4 requirements
Application fee
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A national fund run by AIFA pays, patient by patient, for orphan medicines for rare diseases and for medicines that offer hope of therapy for serious conditions while they await marketing. The fund comes from a contribution of 5% of the promotional spending of pharmaceutical companies. A named patient with a rare or serious condition and no valid alternative, especially among reimbursed medicines, where no company or regional funds are available.
1. Request by the treating centre; 2. AIFA assessment; 3. Funding approval; 4. Treatment start; 5. Reimbursement.
Outcome: AIFA approval of funding for the named patient's treatment and later reimbursement of the costs.
Legal basis: Decree-Law 269/2003, article 48, paragraphs 18 and 19, converted by Law 326/2003.
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 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, Compassionate use of a medicine under clinical investigation, 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.