Italy · Italian Medicines Agency · New drugs
Review target
120 days
law
Legal time limit
-
Not published
Steps
6
5 requirements
Application fee
€97,856
From April 2026
For a medicine not yet authorised anywhere in the EU, the company can ask AIFA to lead a decentralised procedure as reference member state. Italian law sets AIFA's draft assessment at 120 days and the national authorisation at 30 days after all countries agree. A medicine with no authorisation yet in any EU country, for which the company wants authorisations in Italy and other EU countries at the same time, with AIFA as the lead assessor.
The official review target is 120 days (law). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The decentralised procedure, italy as reference state, full or well-established use dossier: one strength, form and pack is €97,856 for From April 2026.
1. Ask AIFA to act as reference state; 2. Send the identical dossier; 3. Draft assessment report (120 days); 4. Review by concerned countries (90 days); 5. Disagreement procedure (if needed); 6. National authorisation in Italy (30 days).
Outcome: A national authorisation in Italy, issued within 30 days after the concerned countries agree, plus national authorisations in the other countries.
Legal basis: Legislative Decree 219/2006, articles 41, 42 and 44, implementing Directive 2001/83/EC.
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 240 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
| Decisionlaw. Italian authorisation after the concerned countries agree. | 30 days |
| Review targetlaw. Draft assessment report from AIFA as reference state. This is an official target, not an actual review time. | 120 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Decentralised procedure, Italy as reference state, full or well-established use dossier: one strength, form and packApplication · From April 2026 | €97,856 |
| Decentralised procedure, Italy as reference state, similar biological medicine: one strength, form and packApplication · From April 2026 | €63,269 |
| Decentralised procedure, Italy as reference state, generic or hybrid dossier: one strength, form and packApplication · From April 2026 | €37,961 |
Other routes in Italy: National marketing authorisation (full dossier), National marketing authorisation for a generic or hybrid medicine, National marketing authorisation (well-established use, bibliographic), 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), 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 (20 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.