Italy · Italian Medicines Agency · New drugs
Review target
90 days
law
Legal time limit
-
Not published
Steps
4
4 requirements
Application fee
€81,546
From April 2026
When another EU country leads the procedure, AIFA recognises or approves that country's assessment within 90 days and then adopts the Italian decision within 30 days of the general consensus. Italian fees and Italian-language product texts apply. A medicine authorised, or being assessed, by another EU country acting as reference member state, for which the company wants an Italian authorisation.
The official review target is 90 days (law). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The italy as concerned state, full or well-established use dossier: one strength, form and pack is €81,546 for From April 2026.
1. Send the identical dossier to AIFA; 2. Recognition or approval of the reference state assessment (90 days); 3. Disagreement procedure (if needed); 4. Italian decision (30 days).
Outcome: An Italian authorisation consistent with the agreed assessment report, product summary, labels and leaflet.
Legal basis: Legislative Decree 219/2006, articles 41, 43 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 120 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 decision after the general consensus. | 30 days |
| Review targetlaw. Recognition or approval by AIFA as concerned state. This is an official target, not an actual review time. | 90 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Italy as concerned state, full or well-established use dossier: one strength, form and packApplication · From April 2026 | €81,546 |
| Italy as concerned state, generic or hybrid dossier: one strength, form and packApplication · From April 2026 | €31,635 |
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), Decentralised procedure with Italy as reference member state, Mutual recognition procedure with Italy as reference 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.