Italy · Italian Medicines Agency · New drugs
Review target
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Not published
Legal time limit
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Not published
Steps
6
5 requirements
Application fee
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Medicines on a special AIFA list are paid in full by the national health service when there is no valid alternative. The list can include medicines authorised abroad but not in Italy, medicines still in clinical trials, and off-label uses. Inclusion needs an opinion of the AIFA scientific and economic committee and a board decision. A serious condition with no valid authorised alternative, where completed studies of at least phase II show adequate efficacy and acceptable risk. Some off-label uses can be listed even when an alternative exists.
1. Documented request; 2. Secretariat opinion; 3. Committee opinion; 4. Board decision; 5. Publication of the listing; 6. Monitoring by prescribing centres.
Outcome: Listing in the Law 648/1996 list, published in the Official Gazette, with full coverage by the national health service.
Legal basis: Decree-Law 536/1996, article 1, paragraph 4, converted by Law 648/1996; Law 79/2014, article 3.
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 AIFA national fund (5% fund), 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.